Sherry Boschert

SAN FRANCISCO – Adults with diabetes who started insulin achieved similar levels of glycemic control within 6 months whether they were managed by primary care physicians or specialists, according to a post hoc analysis of data on 17,374 patients.

Primary care physicians had more face-to-face visits and phone contacts with patients and took more time to train patients on insulin use, compared with specialists, which may be why patients seen by primary care physicians had more insulin dose adjustments and were less likely to develop hypoglycemia, Dr. Louise Faerch reported at the annual scientific sessions of the American Diabetes Association.

The data were collected prior to starting insulin and at 12 and 24 weeks after insulin initiation in the 10-country observational SOLVE (Study of Once-Daily Levemir) study (Diabetes Obes. Metab. 2012;14:654-61), which primarily studied the timing of starting insulin.

Hemoglobin A_1c (HbA_1c) levels decreased by a mean of 1.3% in the 13,230 patients managed by specialists and by 1.2% in the 4,144 patients seen in primary care. Fasting blood glucose levels decreased by a mean of 3.1 mmol/L in the specialist group and by 2.9 mmol/L in the primary care group, reported Dr. Faerch of Novo Nordisk, Søborg, Denmark.

Patients seen by primary care providers were 25% less likely to have a hypoglycemic episode after starting insulin, compared with the specialist group, a difference that was significant, she said. The incidences of minor or severe hypoglycemia fell insignificantly in the primary care group, compared with before insulin initiation. In the specialist group, the incidence of minor hypoglycemia increased significantly and the incidence of severe hypoglycemia decreased significantly, compared with before insulin initiation.

The starting dose of insulin increased by 24 weeks in both groups but significantly more in the primary care group than in the specialist group, by a difference of 0.06 units/kg, after adjustment for the effects of confounding characteristics.

Patients in the primary care group lost a mean of 1.1 kg, compared with 0.4 kg in the specialist group, and had a 7% greater odds of losing at least 1 kg than did the specialist group, a significant difference.

Rates of office visits or phone contacts and the number of insulin dose changes were significantly higher in the primary care group at the 12- and 24-week follow-ups, she reported. The insulin dose was adjusted a mean of five times within 12 weeks and three times in the next 12 weeks in the primary care group, compared with three adjustments within 12 weeks and another two adjustments by 24 weeks in the specialist group.

Primary care physicians spent an average of approximately 18 minutes in training each patient on self-injection, 13 minutes on dose adjustments, and 22 minutes on other aspects of insulin treatment (such as diet and glucose monitoring), while specialists spent approximately 14 minutes on self-injection, 11 minutes on dose adjustment, and 16 minutes on other aspects of treatment.

Clinicians in the study were asked to follow the guidelines for diabetes treatment in their countries. Other than that, treatment choices were at the discretion of each physician, Dr. Faerch said.

Before starting insulin, patients in the primary care group were significantly older (64 years) than those in the specialist group (61 years); were heavier (88 kg vs. 79 kg, respectively); and were significantly more likely to have a history of macrovascular complications (30% vs. 26%), hypoglycemia (5.6% vs. 4.7%), and severe hypoglycemia (0.1 events vs. 0 events per person-year). Patients in the primary care group were more likely to be on just one oral antidiabetic drug (40%), compared with the specialist group (27%).

The study controlled for the effects of confounders including age, duration of diabetes, body mass index, history of hypoglycemia or macrovascular disease, number of oral antidiabetic drugs being taken at baseline, change in the number of oral antidiabetics used, time of insulin initiation, HbA_1c levels at baseline, and insulin dose.

Dr. Faerch works for Novo Nordisk, which funded the study and markets diabetes medications.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

SAN FRANCISCO – Adults with diabetes who started insulin achieved similar levels of glycemic control within 6 months whether they were managed by primary care physicians or specialists, according to a post hoc analysis of data on 17,374 patients.

Primary care physicians had more face-to-face visits and phone contacts with patients and took more time to train patients on insulin use, compared with specialists, which may be why patients seen by primary care physicians had more insulin dose adjustments and were less likely to develop hypoglycemia, Dr. Louise Faerch reported at the annual scientific sessions of the American Diabetes Association.

The data were collected prior to starting insulin and at 12 and 24 weeks after insulin initiation in the 10-country observational SOLVE (Study of Once-Daily Levemir) study (Diabetes Obes. Metab. 2012;14:654-61), which primarily studied the timing of starting insulin.

Hemoglobin A_1c (HbA_1c) levels decreased by a mean of 1.3% in the 13,230 patients managed by specialists and by 1.2% in the 4,144 patients seen in primary care. Fasting blood glucose levels decreased by a mean of 3.1 mmol/L in the specialist group and by 2.9 mmol/L in the primary care group, reported Dr. Faerch of Novo Nordisk, Søborg, Denmark.

Patients seen by primary care providers were 25% less likely to have a hypoglycemic episode after starting insulin, compared with the specialist group, a difference that was significant, she said. The incidences of minor or severe hypoglycemia fell insignificantly in the primary care group, compared with before insulin initiation. In the specialist group, the incidence of minor hypoglycemia increased significantly and the incidence of severe hypoglycemia decreased significantly, compared with before insulin initiation.

The starting dose of insulin increased by 24 weeks in both groups but significantly more in the primary care group than in the specialist group, by a difference of 0.06 units/kg, after adjustment for the effects of confounding characteristics.

Patients in the primary care group lost a mean of 1.1 kg, compared with 0.4 kg in the specialist group, and had a 7% greater odds of losing at least 1 kg than did the specialist group, a significant difference.

Rates of office visits or phone contacts and the number of insulin dose changes were significantly higher in the primary care group at the 12- and 24-week follow-ups, she reported. The insulin dose was adjusted a mean of five times within 12 weeks and three times in the next 12 weeks in the primary care group, compared with three adjustments within 12 weeks and another two adjustments by 24 weeks in the specialist group.

Primary care physicians spent an average of approximately 18 minutes in training each patient on self-injection, 13 minutes on dose adjustments, and 22 minutes on other aspects of insulin treatment (such as diet and glucose monitoring), while specialists spent approximately 14 minutes on self-injection, 11 minutes on dose adjustment, and 16 minutes on other aspects of treatment.

Clinicians in the study were asked to follow the guidelines for diabetes treatment in their countries. Other than that, treatment choices were at the discretion of each physician, Dr. Faerch said.

Before starting insulin, patients in the primary care group were significantly older (64 years) than those in the specialist group (61 years); were heavier (88 kg vs. 79 kg, respectively); and were significantly more likely to have a history of macrovascular complications (30% vs. 26%), hypoglycemia (5.6% vs. 4.7%), and severe hypoglycemia (0.1 events vs. 0 events per person-year). Patients in the primary care group were more likely to be on just one oral antidiabetic drug (40%), compared with the specialist group (27%).

The study controlled for the effects of confounders including age, duration of diabetes, body mass index, history of hypoglycemia or macrovascular disease, number of oral antidiabetic drugs being taken at baseline, change in the number of oral antidiabetics used, time of insulin initiation, HbA_1c levels at baseline, and insulin dose.

Dr. Faerch works for Novo Nordisk, which funded the study and markets diabetes medications.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

SAN FRANCISCO – Adults with diabetes who started insulin achieved similar levels of glycemic control within 6 months whether they were managed by primary care physicians or specialists, according to a post hoc analysis of data on 17,374 patients.

Primary care physicians had more face-to-face visits and phone contacts with patients and took more time to train patients on insulin use, compared with specialists, which may be why patients seen by primary care physicians had more insulin dose adjustments and were less likely to develop hypoglycemia, Dr. Louise Faerch reported at the annual scientific sessions of the American Diabetes Association.

The data were collected prior to starting insulin and at 12 and 24 weeks after insulin initiation in the 10-country observational SOLVE (Study of Once-Daily Levemir) study (Diabetes Obes. Metab. 2012;14:654-61), which primarily studied the timing of starting insulin.

Hemoglobin A_1c (HbA_1c) levels decreased by a mean of 1.3% in the 13,230 patients managed by specialists and by 1.2% in the 4,144 patients seen in primary care. Fasting blood glucose levels decreased by a mean of 3.1 mmol/L in the specialist group and by 2.9 mmol/L in the primary care group, reported Dr. Faerch of Novo Nordisk, Søborg, Denmark.

Patients seen by primary care providers were 25% less likely to have a hypoglycemic episode after starting insulin, compared with the specialist group, a difference that was significant, she said. The incidences of minor or severe hypoglycemia fell insignificantly in the primary care group, compared with before insulin initiation. In the specialist group, the incidence of minor hypoglycemia increased significantly and the incidence of severe hypoglycemia decreased significantly, compared with before insulin initiation.

The starting dose of insulin increased by 24 weeks in both groups but significantly more in the primary care group than in the specialist group, by a difference of 0.06 units/kg, after adjustment for the effects of confounding characteristics.

Patients in the primary care group lost a mean of 1.1 kg, compared with 0.4 kg in the specialist group, and had a 7% greater odds of losing at least 1 kg than did the specialist group, a significant difference.

Rates of office visits or phone contacts and the number of insulin dose changes were significantly higher in the primary care group at the 12- and 24-week follow-ups, she reported. The insulin dose was adjusted a mean of five times within 12 weeks and three times in the next 12 weeks in the primary care group, compared with three adjustments within 12 weeks and another two adjustments by 24 weeks in the specialist group.

Primary care physicians spent an average of approximately 18 minutes in training each patient on self-injection, 13 minutes on dose adjustments, and 22 minutes on other aspects of insulin treatment (such as diet and glucose monitoring), while specialists spent approximately 14 minutes on self-injection, 11 minutes on dose adjustment, and 16 minutes on other aspects of treatment.

Clinicians in the study were asked to follow the guidelines for diabetes treatment in their countries. Other than that, treatment choices were at the discretion of each physician, Dr. Faerch said.

Before starting insulin, patients in the primary care group were significantly older (64 years) than those in the specialist group (61 years); were heavier (88 kg vs. 79 kg, respectively); and were significantly more likely to have a history of macrovascular complications (30% vs. 26%), hypoglycemia (5.6% vs. 4.7%), and severe hypoglycemia (0.1 events vs. 0 events per person-year). Patients in the primary care group were more likely to be on just one oral antidiabetic drug (40%), compared with the specialist group (27%).

The study controlled for the effects of confounders including age, duration of diabetes, body mass index, history of hypoglycemia or macrovascular disease, number of oral antidiabetic drugs being taken at baseline, change in the number of oral antidiabetics used, time of insulin initiation, HbA_1c levels at baseline, and insulin dose.

Dr. Faerch works for Novo Nordisk, which funded the study and markets diabetes medications.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

Mobile app interventions for people with diabetes improved glycemic control in separate studies reported at the annual scientific sessions of the American Diabetes Association, San Francisco.

Interim results from a prospective randomized controlled study of 106 patients from a medically underserved Hispanic population with poorly controlled type 2 diabetes found that hemoglobin A_1c (HbA_1c) levels decreased by an average of a relative 12% after 6 months in those who used a text-messaging intervention called Dulce Digital on their mobile phones in addition to receiving usual care, compared with a 2% relative decrease in the control patients who received usual care alone.

Mean HbA_1c levels decreased from 9.4% at baseline in the Dulce Digital group to 8.4% after 3 months and at 6 months. In the control group, mean HbA_1c levels started at 9.5%, decreased to 9.2% at 3 months, and increased to 9.3% at 6 months. The differences between groups were statistically significant, nurse practitioner Maria Isabel Garcia reported.

Changes in other measures, including weight, blood pressure, or lipids, did not differ significantly between groups, said Ms. Garcia of Scripps Health, San Diego.

Patients in the Dulce Digital group who had no cell phone or had limited text-messaging service, received a phone with unlimited messaging. They then received two or three texts per day initially, with the frequency tapering over a 6-month period. Three kinds of texts were sent. Educational messages included a reminder to "Use small plates! Portions will look larger, and you may feel more satisfied after eating." Medication reminders might say, "Tick, tock. Take your medication at the same time every day!" Blood glucose prompts reminded patients, "Time to check your blood sugar! Text back your results."

Nurses monitored blood glucose responses and called the patient if they saw one reported value greater than 250 mg/L or less than 70 mg/dL, three values in the 181- to 250-mg/dL range within 1 month, or no texts back for 1 week.

"Ninety-one percent of the U.S. population already has a cell phone. So let’s use that as a way to circumvent these barriers to access to care," Ms. Garcia said. She and her associates are pursuing funding for further study of Dulce Digital with longer follow-up.

In a separate randomized, controlled French study of 190 adults with type 2 diabetes who were starting insulin, the Telediab2 software system loaded onto patients’ phones nearly doubled the likelihood that patients would achieve HbA_1c levels of less than 7% by 13 months (31%), compared with patients in a control group or a third group who used a simplified software intervention for only the first 4 months (19%), Dr. Sylvia Franc reported in a poster presentation.

The TeleDiab2 system provides automatic basal insulin titration based on blood glucose targets and rules devised by the treating physician, as well as automatic personalized coaching for blood glucose monitoring, diet, and physical activity based on pre- and postprandial blood glucose values. The app enables remote telemonitoring and short teleconsultations, said Dr. Franc of Sud-Francilien Hospital, Corbeil Essones, France.

Physicians initiated and titrated basal insulin at baseline. Patients in the control group then received face-to-face consultations every 3 months. The simplified intervention group received phone consultations through the app for the first 4 months (and had significantly improved HbA_1c levels, compared with the control group, in that period), then had face-to-face visits every 3 months. Patients in the Telediab2 group had no face-to-face visits; they had phone consultations every 2 weeks until month 4, then monthly phone consultations.

Mobile technology also impressed attendees at the meeting in four small studies showing progress in early attempts to develop an "artificial pancreas." In two 5-day crossover studies, 52 U.S. adults and adolescents with type 1 diabetes using a bionic insulin-glucagon pancreas achieved better glycemic control than did patients using insulin pump therapy (N. Engl. J. Med. 2014 June 15 [doi:10.1056/NEJMoa1314474]). The FlorenceD2 closed-loop insulin delivery system seemed to improve glucose control when used by patients at home in two small European randomized crossover studies.

Dr. Garcia and Dr. Franc reported having no financial disclosures. Lifescan, which sells glucose monitoring products, supported Dr. Garcia’s study.

sboschert@frontlinemedcom.com

On Twitter @SherryBoschert

Mobile app interventions for people with diabetes improved glycemic control in separate studies reported at the annual scientific sessions of the American Diabetes Association, San Francisco.

Interim results from a prospective randomized controlled study of 106 patients from a medically underserved Hispanic population with poorly controlled type 2 diabetes found that hemoglobin A_1c (HbA_1c) levels decreased by an average of a relative 12% after 6 months in those who used a text-messaging intervention called Dulce Digital on their mobile phones in addition to receiving usual care, compared with a 2% relative decrease in the control patients who received usual care alone.

Mean HbA_1c levels decreased from 9.4% at baseline in the Dulce Digital group to 8.4% after 3 months and at 6 months. In the control group, mean HbA_1c levels started at 9.5%, decreased to 9.2% at 3 months, and increased to 9.3% at 6 months. The differences between groups were statistically significant, nurse practitioner Maria Isabel Garcia reported.

Changes in other measures, including weight, blood pressure, or lipids, did not differ significantly between groups, said Ms. Garcia of Scripps Health, San Diego.

Patients in the Dulce Digital group who had no cell phone or had limited text-messaging service, received a phone with unlimited messaging. They then received two or three texts per day initially, with the frequency tapering over a 6-month period. Three kinds of texts were sent. Educational messages included a reminder to "Use small plates! Portions will look larger, and you may feel more satisfied after eating." Medication reminders might say, "Tick, tock. Take your medication at the same time every day!" Blood glucose prompts reminded patients, "Time to check your blood sugar! Text back your results."

Nurses monitored blood glucose responses and called the patient if they saw one reported value greater than 250 mg/L or less than 70 mg/dL, three values in the 181- to 250-mg/dL range within 1 month, or no texts back for 1 week.

"Ninety-one percent of the U.S. population already has a cell phone. So let’s use that as a way to circumvent these barriers to access to care," Ms. Garcia said. She and her associates are pursuing funding for further study of Dulce Digital with longer follow-up.

In a separate randomized, controlled French study of 190 adults with type 2 diabetes who were starting insulin, the Telediab2 software system loaded onto patients’ phones nearly doubled the likelihood that patients would achieve HbA_1c levels of less than 7% by 13 months (31%), compared with patients in a control group or a third group who used a simplified software intervention for only the first 4 months (19%), Dr. Sylvia Franc reported in a poster presentation.

The TeleDiab2 system provides automatic basal insulin titration based on blood glucose targets and rules devised by the treating physician, as well as automatic personalized coaching for blood glucose monitoring, diet, and physical activity based on pre- and postprandial blood glucose values. The app enables remote telemonitoring and short teleconsultations, said Dr. Franc of Sud-Francilien Hospital, Corbeil Essones, France.

Physicians initiated and titrated basal insulin at baseline. Patients in the control group then received face-to-face consultations every 3 months. The simplified intervention group received phone consultations through the app for the first 4 months (and had significantly improved HbA_1c levels, compared with the control group, in that period), then had face-to-face visits every 3 months. Patients in the Telediab2 group had no face-to-face visits; they had phone consultations every 2 weeks until month 4, then monthly phone consultations.

Mobile technology also impressed attendees at the meeting in four small studies showing progress in early attempts to develop an "artificial pancreas." In two 5-day crossover studies, 52 U.S. adults and adolescents with type 1 diabetes using a bionic insulin-glucagon pancreas achieved better glycemic control than did patients using insulin pump therapy (N. Engl. J. Med. 2014 June 15 [doi:10.1056/NEJMoa1314474]). The FlorenceD2 closed-loop insulin delivery system seemed to improve glucose control when used by patients at home in two small European randomized crossover studies.

Dr. Garcia and Dr. Franc reported having no financial disclosures. Lifescan, which sells glucose monitoring products, supported Dr. Garcia’s study.

sboschert@frontlinemedcom.com

On Twitter @SherryBoschert

Mobile app interventions for people with diabetes improved glycemic control in separate studies reported at the annual scientific sessions of the American Diabetes Association, San Francisco.

Interim results from a prospective randomized controlled study of 106 patients from a medically underserved Hispanic population with poorly controlled type 2 diabetes found that hemoglobin A_1c (HbA_1c) levels decreased by an average of a relative 12% after 6 months in those who used a text-messaging intervention called Dulce Digital on their mobile phones in addition to receiving usual care, compared with a 2% relative decrease in the control patients who received usual care alone.

Mean HbA_1c levels decreased from 9.4% at baseline in the Dulce Digital group to 8.4% after 3 months and at 6 months. In the control group, mean HbA_1c levels started at 9.5%, decreased to 9.2% at 3 months, and increased to 9.3% at 6 months. The differences between groups were statistically significant, nurse practitioner Maria Isabel Garcia reported.

Changes in other measures, including weight, blood pressure, or lipids, did not differ significantly between groups, said Ms. Garcia of Scripps Health, San Diego.

Patients in the Dulce Digital group who had no cell phone or had limited text-messaging service, received a phone with unlimited messaging. They then received two or three texts per day initially, with the frequency tapering over a 6-month period. Three kinds of texts were sent. Educational messages included a reminder to "Use small plates! Portions will look larger, and you may feel more satisfied after eating." Medication reminders might say, "Tick, tock. Take your medication at the same time every day!" Blood glucose prompts reminded patients, "Time to check your blood sugar! Text back your results."

Nurses monitored blood glucose responses and called the patient if they saw one reported value greater than 250 mg/L or less than 70 mg/dL, three values in the 181- to 250-mg/dL range within 1 month, or no texts back for 1 week.

"Ninety-one percent of the U.S. population already has a cell phone. So let’s use that as a way to circumvent these barriers to access to care," Ms. Garcia said. She and her associates are pursuing funding for further study of Dulce Digital with longer follow-up.

In a separate randomized, controlled French study of 190 adults with type 2 diabetes who were starting insulin, the Telediab2 software system loaded onto patients’ phones nearly doubled the likelihood that patients would achieve HbA_1c levels of less than 7% by 13 months (31%), compared with patients in a control group or a third group who used a simplified software intervention for only the first 4 months (19%), Dr. Sylvia Franc reported in a poster presentation.

The TeleDiab2 system provides automatic basal insulin titration based on blood glucose targets and rules devised by the treating physician, as well as automatic personalized coaching for blood glucose monitoring, diet, and physical activity based on pre- and postprandial blood glucose values. The app enables remote telemonitoring and short teleconsultations, said Dr. Franc of Sud-Francilien Hospital, Corbeil Essones, France.

Physicians initiated and titrated basal insulin at baseline. Patients in the control group then received face-to-face consultations every 3 months. The simplified intervention group received phone consultations through the app for the first 4 months (and had significantly improved HbA_1c levels, compared with the control group, in that period), then had face-to-face visits every 3 months. Patients in the Telediab2 group had no face-to-face visits; they had phone consultations every 2 weeks until month 4, then monthly phone consultations.

Mobile technology also impressed attendees at the meeting in four small studies showing progress in early attempts to develop an "artificial pancreas." In two 5-day crossover studies, 52 U.S. adults and adolescents with type 1 diabetes using a bionic insulin-glucagon pancreas achieved better glycemic control than did patients using insulin pump therapy (N. Engl. J. Med. 2014 June 15 [doi:10.1056/NEJMoa1314474]). The FlorenceD2 closed-loop insulin delivery system seemed to improve glucose control when used by patients at home in two small European randomized crossover studies.

Dr. Garcia and Dr. Franc reported having no financial disclosures. Lifescan, which sells glucose monitoring products, supported Dr. Garcia’s study.

sboschert@frontlinemedcom.com

On Twitter @SherryBoschert

SAN DIEGO – Obstructive sleep apnea mechanisms may be quantified by polysomnography to select patients who are likely to respond to supplemental oxygen therapy if they can’t tolerate continuous positive airway pressure therapy, a study of 19 patients suggested.

"When [continuous positive airway pressure] isn’t enough, we’ve turned to supplemental oxygen," which can greatly reduce the severity of obstructive sleep apnea [OSA] in some patients but is ineffective in others, Scott A. Sands, Ph.D., said at an international conference of the American Thoracic Society.

He and his associates applied their recently validated technique to quantify "loop gain" or breathing control from routine polysomnography in an attempt to identify patients with increased peripheral chemosensitivity, thinking they might be more responsive to oxygen therapy. An elevated loop gain represents an exaggerated ventilatory effort – a sensitive and fast ventilatory drive – in response to apnea or hypopnea, he explained.

The investigators randomized patients with OSA and an apnea-hypopnea index of at least 20 events per hour in a single-blind, sham-controlled crossover study. Patients underwent full polysomnography with either supplemental oxygen or air (the sham treatment), which was repeated with the other treatment 1 week later.

The results showed that OSA improved substantially in patients with high loop gain but not in those with low loop gain, reported Dr. Sands of Brigham and Women’s Hospital, Boston.

The apnea-hypopnea index improved significantly in patients with high loop gain when they got oxygen but not in patients with low loop gain. Apnea-hypopnea events ranged from approximately 20 to 90 per hour in patients with high loop gain while on air and from approximately 0 to 45 per hour on oxygen. In patients with low loop gain, apnea-hypopnea events ranged from approximately 25 to 110 per hour while on air and from 10 to 80 per hour on oxygen.

The percentage of sleep with stable breathing improved significantly from less than 20% while on air to approximately 35% on oxygen in patients with high loop gain but hovered just under 15% with either treatment in patients with low loop gain.

The arousal index improved significantly from nearly 50 events per hour while on air to 20 events per hour on oxygen in patients with high loop gain but hovered around 50 events per hour on either treatment in patients with low loop gain. The percentage of sleep spent in stage 1 sleep improved significantly from approximately 16% while on air to approximately 6% on oxygen in patients with high loop gain and increased in patients with low loop gain from approximately 15% on air to nearly 20% on oxygen, an increase that was not statistically significant, he said.

"These are promising findings so far," Dr. Sands said. He and his associates are working to fully automate the method of assessing loop gain and to measure additional traits from polysomnography.

Dr. Sands reported having no financial disclosures.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

SAN DIEGO – Obstructive sleep apnea mechanisms may be quantified by polysomnography to select patients who are likely to respond to supplemental oxygen therapy if they can’t tolerate continuous positive airway pressure therapy, a study of 19 patients suggested.

"When [continuous positive airway pressure] isn’t enough, we’ve turned to supplemental oxygen," which can greatly reduce the severity of obstructive sleep apnea [OSA] in some patients but is ineffective in others, Scott A. Sands, Ph.D., said at an international conference of the American Thoracic Society.

He and his associates applied their recently validated technique to quantify "loop gain" or breathing control from routine polysomnography in an attempt to identify patients with increased peripheral chemosensitivity, thinking they might be more responsive to oxygen therapy. An elevated loop gain represents an exaggerated ventilatory effort – a sensitive and fast ventilatory drive – in response to apnea or hypopnea, he explained.

The investigators randomized patients with OSA and an apnea-hypopnea index of at least 20 events per hour in a single-blind, sham-controlled crossover study. Patients underwent full polysomnography with either supplemental oxygen or air (the sham treatment), which was repeated with the other treatment 1 week later.

The results showed that OSA improved substantially in patients with high loop gain but not in those with low loop gain, reported Dr. Sands of Brigham and Women’s Hospital, Boston.

The apnea-hypopnea index improved significantly in patients with high loop gain when they got oxygen but not in patients with low loop gain. Apnea-hypopnea events ranged from approximately 20 to 90 per hour in patients with high loop gain while on air and from approximately 0 to 45 per hour on oxygen. In patients with low loop gain, apnea-hypopnea events ranged from approximately 25 to 110 per hour while on air and from 10 to 80 per hour on oxygen.

The percentage of sleep with stable breathing improved significantly from less than 20% while on air to approximately 35% on oxygen in patients with high loop gain but hovered just under 15% with either treatment in patients with low loop gain.

The arousal index improved significantly from nearly 50 events per hour while on air to 20 events per hour on oxygen in patients with high loop gain but hovered around 50 events per hour on either treatment in patients with low loop gain. The percentage of sleep spent in stage 1 sleep improved significantly from approximately 16% while on air to approximately 6% on oxygen in patients with high loop gain and increased in patients with low loop gain from approximately 15% on air to nearly 20% on oxygen, an increase that was not statistically significant, he said.

"These are promising findings so far," Dr. Sands said. He and his associates are working to fully automate the method of assessing loop gain and to measure additional traits from polysomnography.

Dr. Sands reported having no financial disclosures.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

SAN DIEGO – Obstructive sleep apnea mechanisms may be quantified by polysomnography to select patients who are likely to respond to supplemental oxygen therapy if they can’t tolerate continuous positive airway pressure therapy, a study of 19 patients suggested.

"When [continuous positive airway pressure] isn’t enough, we’ve turned to supplemental oxygen," which can greatly reduce the severity of obstructive sleep apnea [OSA] in some patients but is ineffective in others, Scott A. Sands, Ph.D., said at an international conference of the American Thoracic Society.

He and his associates applied their recently validated technique to quantify "loop gain" or breathing control from routine polysomnography in an attempt to identify patients with increased peripheral chemosensitivity, thinking they might be more responsive to oxygen therapy. An elevated loop gain represents an exaggerated ventilatory effort – a sensitive and fast ventilatory drive – in response to apnea or hypopnea, he explained.

The investigators randomized patients with OSA and an apnea-hypopnea index of at least 20 events per hour in a single-blind, sham-controlled crossover study. Patients underwent full polysomnography with either supplemental oxygen or air (the sham treatment), which was repeated with the other treatment 1 week later.

The results showed that OSA improved substantially in patients with high loop gain but not in those with low loop gain, reported Dr. Sands of Brigham and Women’s Hospital, Boston.

The apnea-hypopnea index improved significantly in patients with high loop gain when they got oxygen but not in patients with low loop gain. Apnea-hypopnea events ranged from approximately 20 to 90 per hour in patients with high loop gain while on air and from approximately 0 to 45 per hour on oxygen. In patients with low loop gain, apnea-hypopnea events ranged from approximately 25 to 110 per hour while on air and from 10 to 80 per hour on oxygen.

The percentage of sleep with stable breathing improved significantly from less than 20% while on air to approximately 35% on oxygen in patients with high loop gain but hovered just under 15% with either treatment in patients with low loop gain.

The arousal index improved significantly from nearly 50 events per hour while on air to 20 events per hour on oxygen in patients with high loop gain but hovered around 50 events per hour on either treatment in patients with low loop gain. The percentage of sleep spent in stage 1 sleep improved significantly from approximately 16% while on air to approximately 6% on oxygen in patients with high loop gain and increased in patients with low loop gain from approximately 15% on air to nearly 20% on oxygen, an increase that was not statistically significant, he said.

"These are promising findings so far," Dr. Sands said. He and his associates are working to fully automate the method of assessing loop gain and to measure additional traits from polysomnography.

Dr. Sands reported having no financial disclosures.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

CHICAGO – An 8-week course in mindfulness-based stress reduction reduced the severity of irritable bowel syndrome symptoms 6 and 12 months later, compared with 8 weeks of participation in a control group, follow-up on 68 women found.

Scores for overall irritable bowel syndrome (IBS) severity on the IBS Severity Scale (IBS-SS) were similar between groups at baseline (284 in the intervention group and 288 in the control group) but had improved significantly more in the mindfulness training group at 6 months (scores decreased 151 and 108 points, respectively) and at 12 months (scores decreased 115 vs. 26 points, respectively) compared with baseline.

The investigators originally reported significant benefits from the mindfulness course, compared with the control group immediately after the group sessions and at 3 months of follow-up in the prospective, randomized, controlled trial involving 75 patients (Am. J. Gastroenterol. 2011;106:1678-88). The current follow-up to 6 and 12 months shows lasting symptomatic improvements from mindfulness training, Olafur S. Palsson, Psy.D., and his associates reported at the annual Digestive Disease Week.

Among the 68 patients who completed 1 year of follow-up in the current analysis, the 33 who got mindfulness training also showed significantly greater improvements in secondary outcomes, compared with the 35 patients in the support group, said Dr. Palsson, a professor of medicine at the University of North Carolina, Chapel Hill.

Scores on the IBS Quality of Life Instrument were similar between groups at baseline (65 in the mindfulness group and 67 in the control group) but improved significantly more in the mindfulness group by 12 months (by 15 vs. 3, respectively).

Scores for gut-focused anxiety on the Visceral Sensitivity Index – which were not significantly different between groups at baseline or immediately after the group sessions – improved significantly more in the mindfulness group than in the control group by 3 months and the gains remained significantly greater at 6 months (by 12 vs. 2, respectively) and at 12 months (by 9 vs. –1, respectively).

"To our knowledge, these follow-up findings demonstrate some of the longest-duration therapeutic effects of mindfulness training ever reported in a clinical trial," he said.

Both interventions consisted of eight weekly sessions and a half-day retreat. The control group attended a conventional support group. The mindfulness course was based on the Mindfulness-Based Stress Reduction Program of Jon Kabat-Zinn, Ph.D., and Saki F. Santorelli, Ed.D., both of the University of Massachusetts, Worcester.

The longitudinal study controlled for the effects of race and income (less than or at least $40,000/year). The results suggest that the impact of mindfulness training on bowel symptom severity and gut-focused anxiety are well maintained and that improvements in health-related quality of life develop gradually over many months after the training, Dr. Palsson said. General psychological well-being did not change significantly based on the training, he added.

Scores for mindfulness on the Five-Facet Mindfulness Questionnaire were higher at every follow-up in the mindfulness group, compared with the control group, but the differences were not statistically significant. Mindfulness scores peaked in the mindfulness group at around 6 months and were attenuated at 12 months.

Patients ranged in age from 19 to 71 years, with a mean age of 43 years. Most patients were white, and women who were minorities or had lower incomes were more likely to drop out of the trial over time.

The National Center for Complementary and Alternative Medicine funded the study. Dr. Palsson and his coinvestigators reported financial associations with Takeda Pharmaceuticals, Ono Pharmaceuticals, Ironwood Pharmaceuticals, Entera Health, and/or the Rome Foundation.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

CHICAGO – An 8-week course in mindfulness-based stress reduction reduced the severity of irritable bowel syndrome symptoms 6 and 12 months later, compared with 8 weeks of participation in a control group, follow-up on 68 women found.

Scores for overall irritable bowel syndrome (IBS) severity on the IBS Severity Scale (IBS-SS) were similar between groups at baseline (284 in the intervention group and 288 in the control group) but had improved significantly more in the mindfulness training group at 6 months (scores decreased 151 and 108 points, respectively) and at 12 months (scores decreased 115 vs. 26 points, respectively) compared with baseline.

The investigators originally reported significant benefits from the mindfulness course, compared with the control group immediately after the group sessions and at 3 months of follow-up in the prospective, randomized, controlled trial involving 75 patients (Am. J. Gastroenterol. 2011;106:1678-88). The current follow-up to 6 and 12 months shows lasting symptomatic improvements from mindfulness training, Olafur S. Palsson, Psy.D., and his associates reported at the annual Digestive Disease Week.

Among the 68 patients who completed 1 year of follow-up in the current analysis, the 33 who got mindfulness training also showed significantly greater improvements in secondary outcomes, compared with the 35 patients in the support group, said Dr. Palsson, a professor of medicine at the University of North Carolina, Chapel Hill.

Scores on the IBS Quality of Life Instrument were similar between groups at baseline (65 in the mindfulness group and 67 in the control group) but improved significantly more in the mindfulness group by 12 months (by 15 vs. 3, respectively).

Scores for gut-focused anxiety on the Visceral Sensitivity Index – which were not significantly different between groups at baseline or immediately after the group sessions – improved significantly more in the mindfulness group than in the control group by 3 months and the gains remained significantly greater at 6 months (by 12 vs. 2, respectively) and at 12 months (by 9 vs. –1, respectively).

"To our knowledge, these follow-up findings demonstrate some of the longest-duration therapeutic effects of mindfulness training ever reported in a clinical trial," he said.

Both interventions consisted of eight weekly sessions and a half-day retreat. The control group attended a conventional support group. The mindfulness course was based on the Mindfulness-Based Stress Reduction Program of Jon Kabat-Zinn, Ph.D., and Saki F. Santorelli, Ed.D., both of the University of Massachusetts, Worcester.

The longitudinal study controlled for the effects of race and income (less than or at least $40,000/year). The results suggest that the impact of mindfulness training on bowel symptom severity and gut-focused anxiety are well maintained and that improvements in health-related quality of life develop gradually over many months after the training, Dr. Palsson said. General psychological well-being did not change significantly based on the training, he added.

Scores for mindfulness on the Five-Facet Mindfulness Questionnaire were higher at every follow-up in the mindfulness group, compared with the control group, but the differences were not statistically significant. Mindfulness scores peaked in the mindfulness group at around 6 months and were attenuated at 12 months.

Patients ranged in age from 19 to 71 years, with a mean age of 43 years. Most patients were white, and women who were minorities or had lower incomes were more likely to drop out of the trial over time.

The National Center for Complementary and Alternative Medicine funded the study. Dr. Palsson and his coinvestigators reported financial associations with Takeda Pharmaceuticals, Ono Pharmaceuticals, Ironwood Pharmaceuticals, Entera Health, and/or the Rome Foundation.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

CHICAGO – An 8-week course in mindfulness-based stress reduction reduced the severity of irritable bowel syndrome symptoms 6 and 12 months later, compared with 8 weeks of participation in a control group, follow-up on 68 women found.

Scores for overall irritable bowel syndrome (IBS) severity on the IBS Severity Scale (IBS-SS) were similar between groups at baseline (284 in the intervention group and 288 in the control group) but had improved significantly more in the mindfulness training group at 6 months (scores decreased 151 and 108 points, respectively) and at 12 months (scores decreased 115 vs. 26 points, respectively) compared with baseline.

The investigators originally reported significant benefits from the mindfulness course, compared with the control group immediately after the group sessions and at 3 months of follow-up in the prospective, randomized, controlled trial involving 75 patients (Am. J. Gastroenterol. 2011;106:1678-88). The current follow-up to 6 and 12 months shows lasting symptomatic improvements from mindfulness training, Olafur S. Palsson, Psy.D., and his associates reported at the annual Digestive Disease Week.

Among the 68 patients who completed 1 year of follow-up in the current analysis, the 33 who got mindfulness training also showed significantly greater improvements in secondary outcomes, compared with the 35 patients in the support group, said Dr. Palsson, a professor of medicine at the University of North Carolina, Chapel Hill.

Scores on the IBS Quality of Life Instrument were similar between groups at baseline (65 in the mindfulness group and 67 in the control group) but improved significantly more in the mindfulness group by 12 months (by 15 vs. 3, respectively).

Scores for gut-focused anxiety on the Visceral Sensitivity Index – which were not significantly different between groups at baseline or immediately after the group sessions – improved significantly more in the mindfulness group than in the control group by 3 months and the gains remained significantly greater at 6 months (by 12 vs. 2, respectively) and at 12 months (by 9 vs. –1, respectively).

"To our knowledge, these follow-up findings demonstrate some of the longest-duration therapeutic effects of mindfulness training ever reported in a clinical trial," he said.

Both interventions consisted of eight weekly sessions and a half-day retreat. The control group attended a conventional support group. The mindfulness course was based on the Mindfulness-Based Stress Reduction Program of Jon Kabat-Zinn, Ph.D., and Saki F. Santorelli, Ed.D., both of the University of Massachusetts, Worcester.

The longitudinal study controlled for the effects of race and income (less than or at least $40,000/year). The results suggest that the impact of mindfulness training on bowel symptom severity and gut-focused anxiety are well maintained and that improvements in health-related quality of life develop gradually over many months after the training, Dr. Palsson said. General psychological well-being did not change significantly based on the training, he added.

Scores for mindfulness on the Five-Facet Mindfulness Questionnaire were higher at every follow-up in the mindfulness group, compared with the control group, but the differences were not statistically significant. Mindfulness scores peaked in the mindfulness group at around 6 months and were attenuated at 12 months.

Patients ranged in age from 19 to 71 years, with a mean age of 43 years. Most patients were white, and women who were minorities or had lower incomes were more likely to drop out of the trial over time.

The National Center for Complementary and Alternative Medicine funded the study. Dr. Palsson and his coinvestigators reported financial associations with Takeda Pharmaceuticals, Ono Pharmaceuticals, Ironwood Pharmaceuticals, Entera Health, and/or the Rome Foundation.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

SAN FRANCISCO – Unsupervised home use of a closed-loop insulin delivery system by patients with type 1 diabetes proved to be feasible and acceptable to patients and seemed to improve glucose control in two small prospective, randomized crossover studies.

The results move development of a potential artificial pancreas one step forward, though much work remains before one ever becomes commercially available.

Courtesy Dr. Lalantha Leelarathna

Both of the multicenter European studies of insulin-dependent adults with type 1 diabetes – one with 24 participants and the other with 17 participants – compared the same experimental closed-loop insulin delivery system (the FlorenceD2 system) with a control treatment that used sensor-augmented insulin pump therapy.

Courtesy Dr. Lalantha Leelarathna

In one study of overnight use, patients using the closed-loop system spent a mean of 53% of nights (midnight to 7 a.m.) with their glucose levels in the target range of 3.9-8.0 mmol/L (70-144 mg/dL), compared with 39% of nights while on the control therapy, a significant difference. In the other study of both day and night use, glucose levels were in the target ranges (3.9-10 mmol/L during the day or 3.9-8 mmol/L at night) for 73% of days and 48% of nights on the closed-loop system, significantly longer than with the control treatment (65% and 35%, respectively).

Investigators reported the findings in separate presentations at the annual scientific sessions of the American Diabetes Association.

The 24-patient night-use study randomized patients to the intervention or control therapy for 4 weeks, then had them switch to the other therapy for 4 weeks. Before taking the closed-loop system home, patients spent one night at a clinical research center for training and to assess their competency to use the automated system.

The proportion of nighttime with hyperglycemia (glucose levels above the 144 mg/dL upper limit of the target range) was significantly lower while on the closed-loop system (44%) than on the control therapy (57%), reported Dr. Hood Thabit of the University of Cambridge (England) and his associates. The proportion of nighttime with hypoglycemia did not differ significantly between groups.

Mean overnight glucose levels were significantly lower while on the closed-loop system (148 mg/dL) than on the control therapy (162 mg/dL), as were mean 24-hour glucose levels (157 mg/dL vs. 167 mg/dL, respectively), the intention-to-treat analysis showed.

Two episodes of severe hypoglycemia occurred while on the closed-loop system, one due to user error and the other for unknown reasons. Both patients made a full recovery, Dr. Thabit said.

The closed-loop system was interrupted unintentionally an average of once every 5 nights, which one physician in the audience called "very impressive."

The separate day-and-night study of 17 adults randomized them to 8 days of either therapy followed by a 1- to 3-week washout period and then 8 days on the other therapy. Again, patients received a day of training at a research facility before using the closed-loop system at home.

During the 7 days of home use with the closed-loop system, patients spent significantly less time in hyperglycemia (levels above 10 mmol/L), compared with the control therapy (21% vs. 30% of the time, respectively), reported Dr. Lalantha Leelarathna, also of the University of Cambridge. Time spent in hypoglycemia did not differ significantly between groups.

Mean glucose levels were significantly lower while patients were on the closed-loop system (8.1 mmol/L) than on the sensor-augmented pump (8.8 mmol/L), he said.

The closed-loop system was interrupted unintentionally every 12 hours on average, mainly because the pump was not connected, the continuous glucose monitor was unavailable, or the user changed pump settings. Two severe hypoglycemic episodes occurred, one during use of the closed-loop system and one during the crossover period. Both patients recovered fully. Four episodes of high glucose because of failure of the insulin infusion set did not lead to ketosis or hospitalization.

"We need to improve portability and connectivity between devices," Dr. Leelarathna said.

The Artificial Pancreas at Home (AP@home) consortium next will test the system in a 3-monthy study of day-and-night use by 30 adults with type 1 diabetes, compared with optimized sensor-augmented pump therapy, Dr. Leelarathna said.

Previous studies conducted exclusively in clinical research facilities have shown that closed-loop insulin delivery systems can improve glucose control, but these are among the first studies to show that they may do the same when used by patients at home.

Dr. Leelarathna and Dr. Thabit reported having no financial disclosures.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

SAN FRANCISCO – Unsupervised home use of a closed-loop insulin delivery system by patients with type 1 diabetes proved to be feasible and acceptable to patients and seemed to improve glucose control in two small prospective, randomized crossover studies.

The results move development of a potential artificial pancreas one step forward, though much work remains before one ever becomes commercially available.

Courtesy Dr. Lalantha Leelarathna

Both of the multicenter European studies of insulin-dependent adults with type 1 diabetes – one with 24 participants and the other with 17 participants – compared the same experimental closed-loop insulin delivery system (the FlorenceD2 system) with a control treatment that used sensor-augmented insulin pump therapy.

Courtesy Dr. Lalantha Leelarathna

In one study of overnight use, patients using the closed-loop system spent a mean of 53% of nights (midnight to 7 a.m.) with their glucose levels in the target range of 3.9-8.0 mmol/L (70-144 mg/dL), compared with 39% of nights while on the control therapy, a significant difference. In the other study of both day and night use, glucose levels were in the target ranges (3.9-10 mmol/L during the day or 3.9-8 mmol/L at night) for 73% of days and 48% of nights on the closed-loop system, significantly longer than with the control treatment (65% and 35%, respectively).

Investigators reported the findings in separate presentations at the annual scientific sessions of the American Diabetes Association.

The 24-patient night-use study randomized patients to the intervention or control therapy for 4 weeks, then had them switch to the other therapy for 4 weeks. Before taking the closed-loop system home, patients spent one night at a clinical research center for training and to assess their competency to use the automated system.

The proportion of nighttime with hyperglycemia (glucose levels above the 144 mg/dL upper limit of the target range) was significantly lower while on the closed-loop system (44%) than on the control therapy (57%), reported Dr. Hood Thabit of the University of Cambridge (England) and his associates. The proportion of nighttime with hypoglycemia did not differ significantly between groups.

Mean overnight glucose levels were significantly lower while on the closed-loop system (148 mg/dL) than on the control therapy (162 mg/dL), as were mean 24-hour glucose levels (157 mg/dL vs. 167 mg/dL, respectively), the intention-to-treat analysis showed.

Two episodes of severe hypoglycemia occurred while on the closed-loop system, one due to user error and the other for unknown reasons. Both patients made a full recovery, Dr. Thabit said.

The closed-loop system was interrupted unintentionally an average of once every 5 nights, which one physician in the audience called "very impressive."

The separate day-and-night study of 17 adults randomized them to 8 days of either therapy followed by a 1- to 3-week washout period and then 8 days on the other therapy. Again, patients received a day of training at a research facility before using the closed-loop system at home.

During the 7 days of home use with the closed-loop system, patients spent significantly less time in hyperglycemia (levels above 10 mmol/L), compared with the control therapy (21% vs. 30% of the time, respectively), reported Dr. Lalantha Leelarathna, also of the University of Cambridge. Time spent in hypoglycemia did not differ significantly between groups.

Mean glucose levels were significantly lower while patients were on the closed-loop system (8.1 mmol/L) than on the sensor-augmented pump (8.8 mmol/L), he said.

The closed-loop system was interrupted unintentionally every 12 hours on average, mainly because the pump was not connected, the continuous glucose monitor was unavailable, or the user changed pump settings. Two severe hypoglycemic episodes occurred, one during use of the closed-loop system and one during the crossover period. Both patients recovered fully. Four episodes of high glucose because of failure of the insulin infusion set did not lead to ketosis or hospitalization.

"We need to improve portability and connectivity between devices," Dr. Leelarathna said.

The Artificial Pancreas at Home (AP@home) consortium next will test the system in a 3-monthy study of day-and-night use by 30 adults with type 1 diabetes, compared with optimized sensor-augmented pump therapy, Dr. Leelarathna said.

Previous studies conducted exclusively in clinical research facilities have shown that closed-loop insulin delivery systems can improve glucose control, but these are among the first studies to show that they may do the same when used by patients at home.

Dr. Leelarathna and Dr. Thabit reported having no financial disclosures.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

SAN FRANCISCO – Unsupervised home use of a closed-loop insulin delivery system by patients with type 1 diabetes proved to be feasible and acceptable to patients and seemed to improve glucose control in two small prospective, randomized crossover studies.

The results move development of a potential artificial pancreas one step forward, though much work remains before one ever becomes commercially available.

Courtesy Dr. Lalantha Leelarathna

Both of the multicenter European studies of insulin-dependent adults with type 1 diabetes – one with 24 participants and the other with 17 participants – compared the same experimental closed-loop insulin delivery system (the FlorenceD2 system) with a control treatment that used sensor-augmented insulin pump therapy.

Courtesy Dr. Lalantha Leelarathna

In one study of overnight use, patients using the closed-loop system spent a mean of 53% of nights (midnight to 7 a.m.) with their glucose levels in the target range of 3.9-8.0 mmol/L (70-144 mg/dL), compared with 39% of nights while on the control therapy, a significant difference. In the other study of both day and night use, glucose levels were in the target ranges (3.9-10 mmol/L during the day or 3.9-8 mmol/L at night) for 73% of days and 48% of nights on the closed-loop system, significantly longer than with the control treatment (65% and 35%, respectively).

Investigators reported the findings in separate presentations at the annual scientific sessions of the American Diabetes Association.

The 24-patient night-use study randomized patients to the intervention or control therapy for 4 weeks, then had them switch to the other therapy for 4 weeks. Before taking the closed-loop system home, patients spent one night at a clinical research center for training and to assess their competency to use the automated system.

The proportion of nighttime with hyperglycemia (glucose levels above the 144 mg/dL upper limit of the target range) was significantly lower while on the closed-loop system (44%) than on the control therapy (57%), reported Dr. Hood Thabit of the University of Cambridge (England) and his associates. The proportion of nighttime with hypoglycemia did not differ significantly between groups.

Mean overnight glucose levels were significantly lower while on the closed-loop system (148 mg/dL) than on the control therapy (162 mg/dL), as were mean 24-hour glucose levels (157 mg/dL vs. 167 mg/dL, respectively), the intention-to-treat analysis showed.

Two episodes of severe hypoglycemia occurred while on the closed-loop system, one due to user error and the other for unknown reasons. Both patients made a full recovery, Dr. Thabit said.

The closed-loop system was interrupted unintentionally an average of once every 5 nights, which one physician in the audience called "very impressive."

The separate day-and-night study of 17 adults randomized them to 8 days of either therapy followed by a 1- to 3-week washout period and then 8 days on the other therapy. Again, patients received a day of training at a research facility before using the closed-loop system at home.

During the 7 days of home use with the closed-loop system, patients spent significantly less time in hyperglycemia (levels above 10 mmol/L), compared with the control therapy (21% vs. 30% of the time, respectively), reported Dr. Lalantha Leelarathna, also of the University of Cambridge. Time spent in hypoglycemia did not differ significantly between groups.

Mean glucose levels were significantly lower while patients were on the closed-loop system (8.1 mmol/L) than on the sensor-augmented pump (8.8 mmol/L), he said.

The closed-loop system was interrupted unintentionally every 12 hours on average, mainly because the pump was not connected, the continuous glucose monitor was unavailable, or the user changed pump settings. Two severe hypoglycemic episodes occurred, one during use of the closed-loop system and one during the crossover period. Both patients recovered fully. Four episodes of high glucose because of failure of the insulin infusion set did not lead to ketosis or hospitalization.

"We need to improve portability and connectivity between devices," Dr. Leelarathna said.

The Artificial Pancreas at Home (AP@home) consortium next will test the system in a 3-monthy study of day-and-night use by 30 adults with type 1 diabetes, compared with optimized sensor-augmented pump therapy, Dr. Leelarathna said.

Previous studies conducted exclusively in clinical research facilities have shown that closed-loop insulin delivery systems can improve glucose control, but these are among the first studies to show that they may do the same when used by patients at home.

Dr. Leelarathna and Dr. Thabit reported having no financial disclosures.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

SAN FRANCISCO – The U.S. incidence of adult diabetes doubled between 1980 and 2008 but has fallen a bit since then, which may be a sign that the diabetes epidemic is abating, according to Linda S. Geiss a health statistician with the Centers for Disease Control and Prevention.

This potentially good news does not apply to everyone, however. Both the incidence and prevalence of diabetes continue to increase in Hispanics, non-Hispanic blacks, and adults with less than a high school education, Ms. Geiss and her associates reported at the annual scientific session of the American Diabetes Association.

They studied annual data from the 1980-2012 National Health Interview Surveys to identify diabetes trends in U.S. residents aged 20-79 years. The age-adjusted prevalence and incidence of diagnosed diabetes changed little in the 1980s but each doubled between 1990 and 2008, she said.

During that time period, the U.S. population became older, less white, and better educated, she noted.

The age-adjusted incidence of diabetes increased from approximately 4/1,000 people in 1980 to more than 9/1,000 in 2008 and then declined to less than 8/1,000 in 2012, a statistically insignificant decrease after 2008. The age-adjusted prevalence of diabetes increased from approximately 4/100 people in 1980 to approximately 8/100 in 2008, with a slight increase after that, "although at a slower rate of pace," Ms. Geiss said.

Even when incidence declines, prevalence can continue to rise if the number of deaths among people with diabetes is smaller than the number of new diagnoses.

"Overall and for some subpopulations, incidence and/or prevalence slowed or plateaued around 2008. Some groups slowed earlier in the 2000s," she said. "After a steady 15- to 20-year increase in prevalence and incidence, we are seeing the first signs that the growth may be slowing or abating. However, given the uncertainty about the reasons behind these changes, future trends are uncertain. Given the large burden of diabetes in the United States, we need to sustain efforts to prevent diabetes and its complications," especially among population groups whose incidence and prevalence rates continue to climb.

Throughout the time period studied, the incidence and prevalence of diabetes were lowest among people aged 20-44 years and highest among people aged 65-79 years. For those two age groups, the incidence of diabetes increased throughout the time period. For middle-aged people of 45-64 years, the incidence plateaued in 2002. The prevalence of diabetes plateaued in 2008 for the middle-aged group and in 2003 for the oldest age group.

Incidence rates for men started to exceed those for women around 1997, continued increasing until 2008, and then declined, though not significantly. The incidence for women increased throughout the time period studied. The prevalence of diabetes plateaued for men in 2001 and for women in 2008.

For adults with a high school education, the incidence of diabetes increased until 2008 and then decreased insignificantly. For other educational levels (more than or less than a high school education), the incidence increased throughout the period. The prevalence slowed among people with more than a high school education in 2000, but increased throughout the time period for the other educational levels.

The incidence and prevalence of diabetes were higher among Hispanics and non-Hispanic blacks than among whites between 1997 and 2012. For whites, the incidence increased from approximately 5/1,000 people in 1997 to 8/1,000 in 2008, then decreased insignificantly to 6/1,000 in 2012. The prevalence of diabetes in whites slowed its rate of increase starting in 2005, Ms. Geiss reported.

"With these cross-sectional data, you can’t determine the reasons behind trend changes," she said. The nationally representative data spanning 3 decades give strength to the findings, but the surveys did not include institutionalized residents or people with undiagnosed diabetes. The study could not distinguish trends for type 1 vs. type 2 diabetes.

One physician in the audience asked if the global financial crisis in 2008 may have been a factor in slowing the diabetes epidemic.

Ms. Geiss said she hadn’t considered that possible explanation. Other factors that may have affected the incidence of diabetes include the adoption of hemoglobin A_1c (HbA_1c) for the diagnosis of diabetes, she speculated. "We know that HbA_1c tends to identify fewer people who have hyperglycemia," she said. Also, U.S. obesity rates have not increased since 2003-2004, and a couple of separate studies have reported declining caloric intake by the U.S. population. Each of these factors may be "prominent drivers" of the slowing incidence of diabetes, she said.

Ms. Geiss reported having no financial disclosures.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

SAN FRANCISCO – The U.S. incidence of adult diabetes doubled between 1980 and 2008 but has fallen a bit since then, which may be a sign that the diabetes epidemic is abating, according to Linda S. Geiss a health statistician with the Centers for Disease Control and Prevention.

This potentially good news does not apply to everyone, however. Both the incidence and prevalence of diabetes continue to increase in Hispanics, non-Hispanic blacks, and adults with less than a high school education, Ms. Geiss and her associates reported at the annual scientific session of the American Diabetes Association.

They studied annual data from the 1980-2012 National Health Interview Surveys to identify diabetes trends in U.S. residents aged 20-79 years. The age-adjusted prevalence and incidence of diagnosed diabetes changed little in the 1980s but each doubled between 1990 and 2008, she said.

During that time period, the U.S. population became older, less white, and better educated, she noted.

The age-adjusted incidence of diabetes increased from approximately 4/1,000 people in 1980 to more than 9/1,000 in 2008 and then declined to less than 8/1,000 in 2012, a statistically insignificant decrease after 2008. The age-adjusted prevalence of diabetes increased from approximately 4/100 people in 1980 to approximately 8/100 in 2008, with a slight increase after that, "although at a slower rate of pace," Ms. Geiss said.

Even when incidence declines, prevalence can continue to rise if the number of deaths among people with diabetes is smaller than the number of new diagnoses.

"Overall and for some subpopulations, incidence and/or prevalence slowed or plateaued around 2008. Some groups slowed earlier in the 2000s," she said. "After a steady 15- to 20-year increase in prevalence and incidence, we are seeing the first signs that the growth may be slowing or abating. However, given the uncertainty about the reasons behind these changes, future trends are uncertain. Given the large burden of diabetes in the United States, we need to sustain efforts to prevent diabetes and its complications," especially among population groups whose incidence and prevalence rates continue to climb.

Throughout the time period studied, the incidence and prevalence of diabetes were lowest among people aged 20-44 years and highest among people aged 65-79 years. For those two age groups, the incidence of diabetes increased throughout the time period. For middle-aged people of 45-64 years, the incidence plateaued in 2002. The prevalence of diabetes plateaued in 2008 for the middle-aged group and in 2003 for the oldest age group.

Incidence rates for men started to exceed those for women around 1997, continued increasing until 2008, and then declined, though not significantly. The incidence for women increased throughout the time period studied. The prevalence of diabetes plateaued for men in 2001 and for women in 2008.

For adults with a high school education, the incidence of diabetes increased until 2008 and then decreased insignificantly. For other educational levels (more than or less than a high school education), the incidence increased throughout the period. The prevalence slowed among people with more than a high school education in 2000, but increased throughout the time period for the other educational levels.

The incidence and prevalence of diabetes were higher among Hispanics and non-Hispanic blacks than among whites between 1997 and 2012. For whites, the incidence increased from approximately 5/1,000 people in 1997 to 8/1,000 in 2008, then decreased insignificantly to 6/1,000 in 2012. The prevalence of diabetes in whites slowed its rate of increase starting in 2005, Ms. Geiss reported.

"With these cross-sectional data, you can’t determine the reasons behind trend changes," she said. The nationally representative data spanning 3 decades give strength to the findings, but the surveys did not include institutionalized residents or people with undiagnosed diabetes. The study could not distinguish trends for type 1 vs. type 2 diabetes.

One physician in the audience asked if the global financial crisis in 2008 may have been a factor in slowing the diabetes epidemic.

Ms. Geiss said she hadn’t considered that possible explanation. Other factors that may have affected the incidence of diabetes include the adoption of hemoglobin A_1c (HbA_1c) for the diagnosis of diabetes, she speculated. "We know that HbA_1c tends to identify fewer people who have hyperglycemia," she said. Also, U.S. obesity rates have not increased since 2003-2004, and a couple of separate studies have reported declining caloric intake by the U.S. population. Each of these factors may be "prominent drivers" of the slowing incidence of diabetes, she said.

Ms. Geiss reported having no financial disclosures.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

SAN FRANCISCO – The U.S. incidence of adult diabetes doubled between 1980 and 2008 but has fallen a bit since then, which may be a sign that the diabetes epidemic is abating, according to Linda S. Geiss a health statistician with the Centers for Disease Control and Prevention.

This potentially good news does not apply to everyone, however. Both the incidence and prevalence of diabetes continue to increase in Hispanics, non-Hispanic blacks, and adults with less than a high school education, Ms. Geiss and her associates reported at the annual scientific session of the American Diabetes Association.

They studied annual data from the 1980-2012 National Health Interview Surveys to identify diabetes trends in U.S. residents aged 20-79 years. The age-adjusted prevalence and incidence of diagnosed diabetes changed little in the 1980s but each doubled between 1990 and 2008, she said.

During that time period, the U.S. population became older, less white, and better educated, she noted.

The age-adjusted incidence of diabetes increased from approximately 4/1,000 people in 1980 to more than 9/1,000 in 2008 and then declined to less than 8/1,000 in 2012, a statistically insignificant decrease after 2008. The age-adjusted prevalence of diabetes increased from approximately 4/100 people in 1980 to approximately 8/100 in 2008, with a slight increase after that, "although at a slower rate of pace," Ms. Geiss said.

Even when incidence declines, prevalence can continue to rise if the number of deaths among people with diabetes is smaller than the number of new diagnoses.

"Overall and for some subpopulations, incidence and/or prevalence slowed or plateaued around 2008. Some groups slowed earlier in the 2000s," she said. "After a steady 15- to 20-year increase in prevalence and incidence, we are seeing the first signs that the growth may be slowing or abating. However, given the uncertainty about the reasons behind these changes, future trends are uncertain. Given the large burden of diabetes in the United States, we need to sustain efforts to prevent diabetes and its complications," especially among population groups whose incidence and prevalence rates continue to climb.

Throughout the time period studied, the incidence and prevalence of diabetes were lowest among people aged 20-44 years and highest among people aged 65-79 years. For those two age groups, the incidence of diabetes increased throughout the time period. For middle-aged people of 45-64 years, the incidence plateaued in 2002. The prevalence of diabetes plateaued in 2008 for the middle-aged group and in 2003 for the oldest age group.

Incidence rates for men started to exceed those for women around 1997, continued increasing until 2008, and then declined, though not significantly. The incidence for women increased throughout the time period studied. The prevalence of diabetes plateaued for men in 2001 and for women in 2008.

For adults with a high school education, the incidence of diabetes increased until 2008 and then decreased insignificantly. For other educational levels (more than or less than a high school education), the incidence increased throughout the period. The prevalence slowed among people with more than a high school education in 2000, but increased throughout the time period for the other educational levels.

The incidence and prevalence of diabetes were higher among Hispanics and non-Hispanic blacks than among whites between 1997 and 2012. For whites, the incidence increased from approximately 5/1,000 people in 1997 to 8/1,000 in 2008, then decreased insignificantly to 6/1,000 in 2012. The prevalence of diabetes in whites slowed its rate of increase starting in 2005, Ms. Geiss reported.

"With these cross-sectional data, you can’t determine the reasons behind trend changes," she said. The nationally representative data spanning 3 decades give strength to the findings, but the surveys did not include institutionalized residents or people with undiagnosed diabetes. The study could not distinguish trends for type 1 vs. type 2 diabetes.

One physician in the audience asked if the global financial crisis in 2008 may have been a factor in slowing the diabetes epidemic.

Ms. Geiss said she hadn’t considered that possible explanation. Other factors that may have affected the incidence of diabetes include the adoption of hemoglobin A_1c (HbA_1c) for the diagnosis of diabetes, she speculated. "We know that HbA_1c tends to identify fewer people who have hyperglycemia," she said. Also, U.S. obesity rates have not increased since 2003-2004, and a couple of separate studies have reported declining caloric intake by the U.S. population. Each of these factors may be "prominent drivers" of the slowing incidence of diabetes, she said.

Ms. Geiss reported having no financial disclosures.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

SAN FRANCISCO – A once-daily subcutaneous injection of an experimental 3-mg dose of liraglutide was significantly more effective than the approved 1.8-mg dose or placebo for weight loss in a randomized, double-blind study of 846 overweight or obese adults with diabetes.

All treatment arms also employed caloric reduction and exercise for weight management. After 56 weeks of therapy, body weight decreased by 5.9% in the 3-mg group, 4.6% in the 1.8-mg group, and 2% in patients on placebo. The mean changes in both liraglutide groups were significantly better than on placebo, and the greater loss on 3 mg, compared with 1.8 mg of liraglutide, also was statistically significant, Dr. Melanie Davies and her associates reported at the annual scientific sessions of the American Diabetes Association.

The percentages of patients who lost at least 5% of body weight by 56 weeks were 50% in the 3-mg group, 36% in the 1.8-mg group, and 14% on placebo. Again, liraglutide at either dose was significantly more effective than placebo, and the higher dose of liraglutide worked significantly better than the lower dose, reported Dr. Davies, professor of diabetes medicine at the University of Leicester (England).

The percentages of patients who lost at least 10% of body weight were 23% in the 3-mg group, 14% in the 1.8-mg group, and 4% on placebo. The same statistical trends were seen, with the higher dose being significantly more effective.

Among secondary outcomes in the SCALE-Diabetes trial (Effect of Liraglutide on Body Weight in Overweight or Obese Subjects with Type 2 Diabetes), greater reductions were seen in hemoglobin A_1c levels after 56 weeks on the higher drug dose. HbA_1c levels fell by 1.3% on the 3-mg dose, compared with 1.1% on the 1.8-mg dose or 0.3% on placebo, Dr. Davies said.

The proportions of patients achieving an HbA_1c level of 6.5% or lower were 57% in the 3-mg group, 46% in the 1.8-mg group, and 15% on placebo. The proportions of patients achieving an HbA_1c level below 7% were 69% in the 3-mg group, 67% in the 1.8-mg group, and 27% in the placebo group. Fasting glucose levels decreased by 34 mg/dL in the 3-mg group, 25 mg/dL in the 1.8-mg group, and 2 mg/dL on placebo. In each case, the 3-mg dose was more effective than the lower dose or placebo, except that the likelihood of getting HbA_1c below 7% was not significantly different between the 3-mg and 1.8-mg liraglutide groups.

Systolic blood pressure measurements decreased by a mean of 3.5 mmHg in the 3-mg group, 2.8 mmHg in the 1.8-mg group, and 0.4 mmHg in the placebo group.

Thirty-four percent in the 3-mg group withdrew before the end of the study, as did 22% in the 1.8-mg group and 23% on placebo.

Rates of side effects were not significantly different between the two liraglutide groups, except for gastrointestinal events, Dr. Davies said. Adverse events were seen in 93% on 3 mg liraglutide, 90% on the 1.8-mg dose, and 86% on placebo. Serious adverse events occurred in 9% in either liraglutide group and in 6% on placebo, and side effects led to withdrawal from the study in 9% of either drug group and in 3% on placebo. Severe episodes of adverse events occurred in 12% in the 3-mg group, 14% in the 1.8-mg group, and 10% on placebo. One death in the 1.8-mg group that occurred after the study ended was not considered to be related to treatment, she said.

The most common side effects were nausea (in 33% on 3 mg, 31% on 1.8 mg, and 14% on placebo), diarrhea (26%, 18%, and 13%, respectively), constipation (16%, 10%, and 6%, respectively), and vomiting (16%, 10%, and 6%, respectively). Most of the increase in nausea among those on the drug resolved by 24 weeks.

Hypoglycemia occurred in 44% of the 3-mg group, 40% of the 1.8-mg group, and 28% in the placebo group and was more common in patients on liraglutide and in patients who also were taking sulfonylurea drugs, she said.

A separate SCALE study in 3,731 nondiabetic patients (Effect of Liraglutide on Body Weight in Non-diabetic Obese Subjects or Overweight Subjects with Comorbidities) found that the 3-mg dose was more effective for weight loss than placebo in adults without diabetes. Although that study detected rates of pancreatitis and gallbladder disorders that were more than twice as common (though still rare) with liraglutide, compared with placebo, there were no episodes of pancreatitis in the current trial, Dr. Davies said. There was no difference in levels of amylase, which is a marker of pancreatitis, between the two drug arms.

Increased lipase levels were seen in 12% on the 3-mg dose, 10% on the 1.8-mg dose, and 7% on placebo, she said. The drug groups showed roughly a 10-unit increase in lipase that occurred early and was maintained during the duration of the study.

"Obviously, there are still some concerns around pancreatitis with GLP1 drugs as a class, but certainly in this study there were no cases of pancreatitis," Dr. Davies said. Only eight patients developed gallstones in the current study, too few to compare rates between groups, she added.

Liraglutide, in formulations of 1.2 mg and 1.8 mg for daily injections, was approved in 2010 for the treatment of type 2 diabetes and is marketed in those doses as Victoza.

Dr. Davies reported having financial associations with Novo Nordisk, which manufactures liraglutide, and with eight other pharmaceutical companies.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

SAN FRANCISCO – A once-daily subcutaneous injection of an experimental 3-mg dose of liraglutide was significantly more effective than the approved 1.8-mg dose or placebo for weight loss in a randomized, double-blind study of 846 overweight or obese adults with diabetes.

All treatment arms also employed caloric reduction and exercise for weight management. After 56 weeks of therapy, body weight decreased by 5.9% in the 3-mg group, 4.6% in the 1.8-mg group, and 2% in patients on placebo. The mean changes in both liraglutide groups were significantly better than on placebo, and the greater loss on 3 mg, compared with 1.8 mg of liraglutide, also was statistically significant, Dr. Melanie Davies and her associates reported at the annual scientific sessions of the American Diabetes Association.

The percentages of patients who lost at least 5% of body weight by 56 weeks were 50% in the 3-mg group, 36% in the 1.8-mg group, and 14% on placebo. Again, liraglutide at either dose was significantly more effective than placebo, and the higher dose of liraglutide worked significantly better than the lower dose, reported Dr. Davies, professor of diabetes medicine at the University of Leicester (England).

The percentages of patients who lost at least 10% of body weight were 23% in the 3-mg group, 14% in the 1.8-mg group, and 4% on placebo. The same statistical trends were seen, with the higher dose being significantly more effective.

Among secondary outcomes in the SCALE-Diabetes trial (Effect of Liraglutide on Body Weight in Overweight or Obese Subjects with Type 2 Diabetes), greater reductions were seen in hemoglobin A_1c levels after 56 weeks on the higher drug dose. HbA_1c levels fell by 1.3% on the 3-mg dose, compared with 1.1% on the 1.8-mg dose or 0.3% on placebo, Dr. Davies said.

The proportions of patients achieving an HbA_1c level of 6.5% or lower were 57% in the 3-mg group, 46% in the 1.8-mg group, and 15% on placebo. The proportions of patients achieving an HbA_1c level below 7% were 69% in the 3-mg group, 67% in the 1.8-mg group, and 27% in the placebo group. Fasting glucose levels decreased by 34 mg/dL in the 3-mg group, 25 mg/dL in the 1.8-mg group, and 2 mg/dL on placebo. In each case, the 3-mg dose was more effective than the lower dose or placebo, except that the likelihood of getting HbA_1c below 7% was not significantly different between the 3-mg and 1.8-mg liraglutide groups.

Systolic blood pressure measurements decreased by a mean of 3.5 mmHg in the 3-mg group, 2.8 mmHg in the 1.8-mg group, and 0.4 mmHg in the placebo group.

Thirty-four percent in the 3-mg group withdrew before the end of the study, as did 22% in the 1.8-mg group and 23% on placebo.

Rates of side effects were not significantly different between the two liraglutide groups, except for gastrointestinal events, Dr. Davies said. Adverse events were seen in 93% on 3 mg liraglutide, 90% on the 1.8-mg dose, and 86% on placebo. Serious adverse events occurred in 9% in either liraglutide group and in 6% on placebo, and side effects led to withdrawal from the study in 9% of either drug group and in 3% on placebo. Severe episodes of adverse events occurred in 12% in the 3-mg group, 14% in the 1.8-mg group, and 10% on placebo. One death in the 1.8-mg group that occurred after the study ended was not considered to be related to treatment, she said.

The most common side effects were nausea (in 33% on 3 mg, 31% on 1.8 mg, and 14% on placebo), diarrhea (26%, 18%, and 13%, respectively), constipation (16%, 10%, and 6%, respectively), and vomiting (16%, 10%, and 6%, respectively). Most of the increase in nausea among those on the drug resolved by 24 weeks.

Hypoglycemia occurred in 44% of the 3-mg group, 40% of the 1.8-mg group, and 28% in the placebo group and was more common in patients on liraglutide and in patients who also were taking sulfonylurea drugs, she said.

A separate SCALE study in 3,731 nondiabetic patients (Effect of Liraglutide on Body Weight in Non-diabetic Obese Subjects or Overweight Subjects with Comorbidities) found that the 3-mg dose was more effective for weight loss than placebo in adults without diabetes. Although that study detected rates of pancreatitis and gallbladder disorders that were more than twice as common (though still rare) with liraglutide, compared with placebo, there were no episodes of pancreatitis in the current trial, Dr. Davies said. There was no difference in levels of amylase, which is a marker of pancreatitis, between the two drug arms.

Increased lipase levels were seen in 12% on the 3-mg dose, 10% on the 1.8-mg dose, and 7% on placebo, she said. The drug groups showed roughly a 10-unit increase in lipase that occurred early and was maintained during the duration of the study.

"Obviously, there are still some concerns around pancreatitis with GLP1 drugs as a class, but certainly in this study there were no cases of pancreatitis," Dr. Davies said. Only eight patients developed gallstones in the current study, too few to compare rates between groups, she added.

Liraglutide, in formulations of 1.2 mg and 1.8 mg for daily injections, was approved in 2010 for the treatment of type 2 diabetes and is marketed in those doses as Victoza.

Dr. Davies reported having financial associations with Novo Nordisk, which manufactures liraglutide, and with eight other pharmaceutical companies.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

SAN FRANCISCO – A once-daily subcutaneous injection of an experimental 3-mg dose of liraglutide was significantly more effective than the approved 1.8-mg dose or placebo for weight loss in a randomized, double-blind study of 846 overweight or obese adults with diabetes.

All treatment arms also employed caloric reduction and exercise for weight management. After 56 weeks of therapy, body weight decreased by 5.9% in the 3-mg group, 4.6% in the 1.8-mg group, and 2% in patients on placebo. The mean changes in both liraglutide groups were significantly better than on placebo, and the greater loss on 3 mg, compared with 1.8 mg of liraglutide, also was statistically significant, Dr. Melanie Davies and her associates reported at the annual scientific sessions of the American Diabetes Association.

The percentages of patients who lost at least 5% of body weight by 56 weeks were 50% in the 3-mg group, 36% in the 1.8-mg group, and 14% on placebo. Again, liraglutide at either dose was significantly more effective than placebo, and the higher dose of liraglutide worked significantly better than the lower dose, reported Dr. Davies, professor of diabetes medicine at the University of Leicester (England).

The percentages of patients who lost at least 10% of body weight were 23% in the 3-mg group, 14% in the 1.8-mg group, and 4% on placebo. The same statistical trends were seen, with the higher dose being significantly more effective.

Among secondary outcomes in the SCALE-Diabetes trial (Effect of Liraglutide on Body Weight in Overweight or Obese Subjects with Type 2 Diabetes), greater reductions were seen in hemoglobin A_1c levels after 56 weeks on the higher drug dose. HbA_1c levels fell by 1.3% on the 3-mg dose, compared with 1.1% on the 1.8-mg dose or 0.3% on placebo, Dr. Davies said.

The proportions of patients achieving an HbA_1c level of 6.5% or lower were 57% in the 3-mg group, 46% in the 1.8-mg group, and 15% on placebo. The proportions of patients achieving an HbA_1c level below 7% were 69% in the 3-mg group, 67% in the 1.8-mg group, and 27% in the placebo group. Fasting glucose levels decreased by 34 mg/dL in the 3-mg group, 25 mg/dL in the 1.8-mg group, and 2 mg/dL on placebo. In each case, the 3-mg dose was more effective than the lower dose or placebo, except that the likelihood of getting HbA_1c below 7% was not significantly different between the 3-mg and 1.8-mg liraglutide groups.

Systolic blood pressure measurements decreased by a mean of 3.5 mmHg in the 3-mg group, 2.8 mmHg in the 1.8-mg group, and 0.4 mmHg in the placebo group.

Thirty-four percent in the 3-mg group withdrew before the end of the study, as did 22% in the 1.8-mg group and 23% on placebo.

Rates of side effects were not significantly different between the two liraglutide groups, except for gastrointestinal events, Dr. Davies said. Adverse events were seen in 93% on 3 mg liraglutide, 90% on the 1.8-mg dose, and 86% on placebo. Serious adverse events occurred in 9% in either liraglutide group and in 6% on placebo, and side effects led to withdrawal from the study in 9% of either drug group and in 3% on placebo. Severe episodes of adverse events occurred in 12% in the 3-mg group, 14% in the 1.8-mg group, and 10% on placebo. One death in the 1.8-mg group that occurred after the study ended was not considered to be related to treatment, she said.

The most common side effects were nausea (in 33% on 3 mg, 31% on 1.8 mg, and 14% on placebo), diarrhea (26%, 18%, and 13%, respectively), constipation (16%, 10%, and 6%, respectively), and vomiting (16%, 10%, and 6%, respectively). Most of the increase in nausea among those on the drug resolved by 24 weeks.

Hypoglycemia occurred in 44% of the 3-mg group, 40% of the 1.8-mg group, and 28% in the placebo group and was more common in patients on liraglutide and in patients who also were taking sulfonylurea drugs, she said.

A separate SCALE study in 3,731 nondiabetic patients (Effect of Liraglutide on Body Weight in Non-diabetic Obese Subjects or Overweight Subjects with Comorbidities) found that the 3-mg dose was more effective for weight loss than placebo in adults without diabetes. Although that study detected rates of pancreatitis and gallbladder disorders that were more than twice as common (though still rare) with liraglutide, compared with placebo, there were no episodes of pancreatitis in the current trial, Dr. Davies said. There was no difference in levels of amylase, which is a marker of pancreatitis, between the two drug arms.

Increased lipase levels were seen in 12% on the 3-mg dose, 10% on the 1.8-mg dose, and 7% on placebo, she said. The drug groups showed roughly a 10-unit increase in lipase that occurred early and was maintained during the duration of the study.

"Obviously, there are still some concerns around pancreatitis with GLP1 drugs as a class, but certainly in this study there were no cases of pancreatitis," Dr. Davies said. Only eight patients developed gallstones in the current study, too few to compare rates between groups, she added.

Liraglutide, in formulations of 1.2 mg and 1.8 mg for daily injections, was approved in 2010 for the treatment of type 2 diabetes and is marketed in those doses as Victoza.

Dr. Davies reported having financial associations with Novo Nordisk, which manufactures liraglutide, and with eight other pharmaceutical companies.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

SAN FRANCISCO – Even small improvements to the quality of diet can help stave off diabetes.

More specifically, adults whose diet quality scores improved by at least 10% were 9% less likely to develop type 2 diabetes in the next 4 years, and those whose diet quality scores worsened by at least 10% were 18% more likely to develop diabetes, according to an analysis of data from three longitudinal observational studies involving 184,417 people.

Those changes in diabetes risk were statistically significant, Sylvia H. Ley, Ph.D., reported at the annual scientific sessions of the American Diabetes Association.

They analyzed data on participants in the Nurses Health Study I, Nurses Health Study II, and the Health Professionals Follow-Up Study who were followed for at least 20 years in each study and asked every 2 years about incident diabetes and every 4 years about the contents of their diet, among other topics. Dr. Ley and her associates used the Alternative Healthy Eating Index to assess diet quality.

Nearly 10,000 new cases of type 2 diabetes were reported during more than 2 million person-years of follow-up, Dr. Ley of Harvard University’s School of Public Health, Boston, said in a press briefing.

The associations between dietary changes and diabetes risk affected all people, whether they ate well or poorly, according to subset analyses of participants grouped as those having the poorest quality diet, medium quality, or highest quality diet. "Regardless of where you start, improving your diet quality is helpful in diabetes prevention," Dr. Ley said.

The reduced diabetes risk from improving diet quality was independent of effects from physical activity or reduced body weight, she said.

The Alternative Healthy Eating Index focused on intake of 11 components: red meat, nuts, sugar-sweetened beverages, fruits, vegetables, polyunsaturated fat, trans fat, omega fats, alcohol, sodium, and whole grains, with up to 10 points for intake of each. A perfect diet score was 110, so a mere 11-point gain provided a 10% improvement in diet quality, she said.

A 10% improvement in diet quality is "not that difficult" to make, Dr. Ley said. Nearly everyone in the study started with a poor-quality diet, and many made more than a 10% improvement in diet quality scores.

The bottom line is that changing one’s diet can be helpful, she said. "I think healthy eating is somewhat abstract, and that people still have difficulty understanding what that means," Dr. Ley said. "I think it’s helpful to provide more information on what is healthy and what is better quality eating."

A separate study by Dr. Ley and her associates found that the quality of foods and drinks consumed is more important than the quantity and that a number of different dietary strategies can reduce diabetes risk (including a Mediterranean diet, vegetarian diet, low-glycemic-index diet, or moderately low carbohydrate diet) because they are rich in whole grains, fruits, vegetables, legumes, and nuts, with moderate to low amounts of alcohol, refined grains, red or processed meats, and sugar-sweetened beverages (Lancet 2014;383:1999-2007).

Other previous randomized, controlled studies had shown that restricting dietary calories can help protect against development of diabetes, but that dietary strategy is difficult for people to maintain, Dr. Ley said. "That has led us to take more food-based approaches," she said. In addition, those studies predominantly looked at people who were at high risk for diabetes, whereas the current study looked at a normal healthy population.

The current findings can’t be generalized to the entire population without further study, however, because participants in the three studies in the analysis were relatively well-educated health care professionals and 98% were white.

Dr. Ley reported having no financial disclosures.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

SAN FRANCISCO – Even small improvements to the quality of diet can help stave off diabetes.

More specifically, adults whose diet quality scores improved by at least 10% were 9% less likely to develop type 2 diabetes in the next 4 years, and those whose diet quality scores worsened by at least 10% were 18% more likely to develop diabetes, according to an analysis of data from three longitudinal observational studies involving 184,417 people.

Those changes in diabetes risk were statistically significant, Sylvia H. Ley, Ph.D., reported at the annual scientific sessions of the American Diabetes Association.

They analyzed data on participants in the Nurses Health Study I, Nurses Health Study II, and the Health Professionals Follow-Up Study who were followed for at least 20 years in each study and asked every 2 years about incident diabetes and every 4 years about the contents of their diet, among other topics. Dr. Ley and her associates used the Alternative Healthy Eating Index to assess diet quality.

Nearly 10,000 new cases of type 2 diabetes were reported during more than 2 million person-years of follow-up, Dr. Ley of Harvard University’s School of Public Health, Boston, said in a press briefing.

The associations between dietary changes and diabetes risk affected all people, whether they ate well or poorly, according to subset analyses of participants grouped as those having the poorest quality diet, medium quality, or highest quality diet. "Regardless of where you start, improving your diet quality is helpful in diabetes prevention," Dr. Ley said.

The reduced diabetes risk from improving diet quality was independent of effects from physical activity or reduced body weight, she said.

The Alternative Healthy Eating Index focused on intake of 11 components: red meat, nuts, sugar-sweetened beverages, fruits, vegetables, polyunsaturated fat, trans fat, omega fats, alcohol, sodium, and whole grains, with up to 10 points for intake of each. A perfect diet score was 110, so a mere 11-point gain provided a 10% improvement in diet quality, she said.

A 10% improvement in diet quality is "not that difficult" to make, Dr. Ley said. Nearly everyone in the study started with a poor-quality diet, and many made more than a 10% improvement in diet quality scores.

The bottom line is that changing one’s diet can be helpful, she said. "I think healthy eating is somewhat abstract, and that people still have difficulty understanding what that means," Dr. Ley said. "I think it’s helpful to provide more information on what is healthy and what is better quality eating."

A separate study by Dr. Ley and her associates found that the quality of foods and drinks consumed is more important than the quantity and that a number of different dietary strategies can reduce diabetes risk (including a Mediterranean diet, vegetarian diet, low-glycemic-index diet, or moderately low carbohydrate diet) because they are rich in whole grains, fruits, vegetables, legumes, and nuts, with moderate to low amounts of alcohol, refined grains, red or processed meats, and sugar-sweetened beverages (Lancet 2014;383:1999-2007).

Other previous randomized, controlled studies had shown that restricting dietary calories can help protect against development of diabetes, but that dietary strategy is difficult for people to maintain, Dr. Ley said. "That has led us to take more food-based approaches," she said. In addition, those studies predominantly looked at people who were at high risk for diabetes, whereas the current study looked at a normal healthy population.

The current findings can’t be generalized to the entire population without further study, however, because participants in the three studies in the analysis were relatively well-educated health care professionals and 98% were white.

Dr. Ley reported having no financial disclosures.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

SAN FRANCISCO – Even small improvements to the quality of diet can help stave off diabetes.

More specifically, adults whose diet quality scores improved by at least 10% were 9% less likely to develop type 2 diabetes in the next 4 years, and those whose diet quality scores worsened by at least 10% were 18% more likely to develop diabetes, according to an analysis of data from three longitudinal observational studies involving 184,417 people.

Those changes in diabetes risk were statistically significant, Sylvia H. Ley, Ph.D., reported at the annual scientific sessions of the American Diabetes Association.

They analyzed data on participants in the Nurses Health Study I, Nurses Health Study II, and the Health Professionals Follow-Up Study who were followed for at least 20 years in each study and asked every 2 years about incident diabetes and every 4 years about the contents of their diet, among other topics. Dr. Ley and her associates used the Alternative Healthy Eating Index to assess diet quality.

Nearly 10,000 new cases of type 2 diabetes were reported during more than 2 million person-years of follow-up, Dr. Ley of Harvard University’s School of Public Health, Boston, said in a press briefing.

The associations between dietary changes and diabetes risk affected all people, whether they ate well or poorly, according to subset analyses of participants grouped as those having the poorest quality diet, medium quality, or highest quality diet. "Regardless of where you start, improving your diet quality is helpful in diabetes prevention," Dr. Ley said.

The reduced diabetes risk from improving diet quality was independent of effects from physical activity or reduced body weight, she said.

The Alternative Healthy Eating Index focused on intake of 11 components: red meat, nuts, sugar-sweetened beverages, fruits, vegetables, polyunsaturated fat, trans fat, omega fats, alcohol, sodium, and whole grains, with up to 10 points for intake of each. A perfect diet score was 110, so a mere 11-point gain provided a 10% improvement in diet quality, she said.

A 10% improvement in diet quality is "not that difficult" to make, Dr. Ley said. Nearly everyone in the study started with a poor-quality diet, and many made more than a 10% improvement in diet quality scores.

The bottom line is that changing one’s diet can be helpful, she said. "I think healthy eating is somewhat abstract, and that people still have difficulty understanding what that means," Dr. Ley said. "I think it’s helpful to provide more information on what is healthy and what is better quality eating."

A separate study by Dr. Ley and her associates found that the quality of foods and drinks consumed is more important than the quantity and that a number of different dietary strategies can reduce diabetes risk (including a Mediterranean diet, vegetarian diet, low-glycemic-index diet, or moderately low carbohydrate diet) because they are rich in whole grains, fruits, vegetables, legumes, and nuts, with moderate to low amounts of alcohol, refined grains, red or processed meats, and sugar-sweetened beverages (Lancet 2014;383:1999-2007).

Other previous randomized, controlled studies had shown that restricting dietary calories can help protect against development of diabetes, but that dietary strategy is difficult for people to maintain, Dr. Ley said. "That has led us to take more food-based approaches," she said. In addition, those studies predominantly looked at people who were at high risk for diabetes, whereas the current study looked at a normal healthy population.

The current findings can’t be generalized to the entire population without further study, however, because participants in the three studies in the analysis were relatively well-educated health care professionals and 98% were white.

Dr. Ley reported having no financial disclosures.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

A free app to help patients with obstructive sleep apnea become accustomed to using continuous positive airway pressure improved adherence during the first 11 weeks of therapy in a randomized, controlled trial with 61 patients.

The mean percentage of nights in which patients used continuous positive airway pressure (CPAP) for at least 4 hours was significantly higher in the 30 patients randomized to usual care plus use of the SleepMapper app (54%), compared with the 31 patients in the control group who got usual care alone (37%), Karen Sheikh reported at the annual meeting of the Associated Professional Sleep Societies in Minneapolis.

Courtesy of Philips Respironics, Murrysville, Penn.

Patients in the app group also used the CPAP device for significantly more nights, compared with the control group – an average of 78% of nights vs. 55%, respectively, said Ms. Sheikh of the research arm of Linthicum, Md.–based Respira, a durable medical equipment company that sponsored the study. Dr. Jordanna M. Hostler of Walter Reed National Medical Center, Bethesda, Md., led the study, which was conducted at Walter Reed (Sleep 2014;37:A106-7).

All patients used the same kind of CPAP equipment and were introduced to the therapy through a 4-hour group session, lectures giving an overview of obstructive sleep apnea, CPAP, and good sleep habits, and a follow-up appointment with a respiratory therapist 30 days later, according to Ms. Sheikh.

The 17% improvement in the SleepMapper group, compared with the control group, in nights in which CPAP was used for at least 4 hours was seen after the influences of maximum PAP pressure and sleep efficiency were controlled for, she reported.

The app can be used with any CPAP equipment made by Philips, the company that developed SleepMapper, according to Mark S. Aloia, Ph.D. In addition to providing information about PAP devices, the app individualizes feedback for patients about their adherence using algorithms based on psychological theories of behavior change.

SleepMapper also performed well in a separate retrospective study of 15,242 patients released by Philips. Compared with 7,601 patients who received standard care without the app, the 7,641 patients using SleepMapper were significantly more likely to be adhering to CPAP therapy in the first 90 days of therapy (78% vs. 56%, respectively).

Among the 12% of app users and 32% of the control group who were considered "struggling users" because they used CPAP an average of fewer than 2 hours per night during the first 2 weeks, 33% of strugglers in the app group and 11% of strugglers in the control group went on to meet CPAP adherence criteria set by the Centers for Medicare & Medicaid Services, according to Philips.

"We are confident that our study demonstrates that SleepMapper can improve patient lives at a population level," Dr. Aloia of Denver, who is senior director of global clinical research for Philips Healthcare, said in an e-mail interview.

Other sleep-related apps – and there are thousands – may not be as effective.

Pulmonologist Ambra Ferraris reported in a separate presentation at the Sleep 2014 meeting that results from the Sleep Time app (by Azumio) for iPhones did not correlate with in-laboratory polysomnography results in a pilot trial in 12 healthy volunteers. The Sleep Time app is not accurate enough for clinical use, suggested Dr. Ferraris of the New Jersey Neuroscience Institute at JFK Medical Center, Seton Hall University, South Orange, N.J.

The Sleep Time app (free or $1.99 version) uses the iPhone’s accelerometer to detect the sleeper’s movements during the night and claims to adjust the wake-up time that the user has set in the phone’s alarm clock so that the alarm goes off during the lightest sleep phase and the person wakes up refreshed instead of groggy.

In the study, volunteers simultaneously used the app and underwent polysomnography in the lab. There was no correlation between the two sets of results for sleep efficiency, percentage of light or deep sleep, or sleep latency, according to Dr. Ferraris's abstract. The app’s overall accuracy was 46% (Sleep 2014;37:A367-8), though it’s unclear whether the app or the smartphones were to blame for the poor accuracy, she said in an e-mail interview.

Ms. Sheikh reported that the investigators in the SleepMapper study had no disclosures. Dr. Aloia works for Philips Healthcare, which markets SleepMapper. Dr. Ferraris reported having no disclosures.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

A free app to help patients with obstructive sleep apnea become accustomed to using continuous positive airway pressure improved adherence during the first 11 weeks of therapy in a randomized, controlled trial with 61 patients.

The mean percentage of nights in which patients used continuous positive airway pressure (CPAP) for at least 4 hours was significantly higher in the 30 patients randomized to usual care plus use of the SleepMapper app (54%), compared with the 31 patients in the control group who got usual care alone (37%), Karen Sheikh reported at the annual meeting of the Associated Professional Sleep Societies in Minneapolis.

Courtesy of Philips Respironics, Murrysville, Penn.

Patients in the app group also used the CPAP device for significantly more nights, compared with the control group – an average of 78% of nights vs. 55%, respectively, said Ms. Sheikh of the research arm of Linthicum, Md.–based Respira, a durable medical equipment company that sponsored the study. Dr. Jordanna M. Hostler of Walter Reed National Medical Center, Bethesda, Md., led the study, which was conducted at Walter Reed (Sleep 2014;37:A106-7).

All patients used the same kind of CPAP equipment and were introduced to the therapy through a 4-hour group session, lectures giving an overview of obstructive sleep apnea, CPAP, and good sleep habits, and a follow-up appointment with a respiratory therapist 30 days later, according to Ms. Sheikh.

The 17% improvement in the SleepMapper group, compared with the control group, in nights in which CPAP was used for at least 4 hours was seen after the influences of maximum PAP pressure and sleep efficiency were controlled for, she reported.

The app can be used with any CPAP equipment made by Philips, the company that developed SleepMapper, according to Mark S. Aloia, Ph.D. In addition to providing information about PAP devices, the app individualizes feedback for patients about their adherence using algorithms based on psychological theories of behavior change.

SleepMapper also performed well in a separate retrospective study of 15,242 patients released by Philips. Compared with 7,601 patients who received standard care without the app, the 7,641 patients using SleepMapper were significantly more likely to be adhering to CPAP therapy in the first 90 days of therapy (78% vs. 56%, respectively).

Among the 12% of app users and 32% of the control group who were considered "struggling users" because they used CPAP an average of fewer than 2 hours per night during the first 2 weeks, 33% of strugglers in the app group and 11% of strugglers in the control group went on to meet CPAP adherence criteria set by the Centers for Medicare & Medicaid Services, according to Philips.

"We are confident that our study demonstrates that SleepMapper can improve patient lives at a population level," Dr. Aloia of Denver, who is senior director of global clinical research for Philips Healthcare, said in an e-mail interview.

Other sleep-related apps – and there are thousands – may not be as effective.

Pulmonologist Ambra Ferraris reported in a separate presentation at the Sleep 2014 meeting that results from the Sleep Time app (by Azumio) for iPhones did not correlate with in-laboratory polysomnography results in a pilot trial in 12 healthy volunteers. The Sleep Time app is not accurate enough for clinical use, suggested Dr. Ferraris of the New Jersey Neuroscience Institute at JFK Medical Center, Seton Hall University, South Orange, N.J.

The Sleep Time app (free or $1.99 version) uses the iPhone’s accelerometer to detect the sleeper’s movements during the night and claims to adjust the wake-up time that the user has set in the phone’s alarm clock so that the alarm goes off during the lightest sleep phase and the person wakes up refreshed instead of groggy.

In the study, volunteers simultaneously used the app and underwent polysomnography in the lab. There was no correlation between the two sets of results for sleep efficiency, percentage of light or deep sleep, or sleep latency, according to Dr. Ferraris's abstract. The app’s overall accuracy was 46% (Sleep 2014;37:A367-8), though it’s unclear whether the app or the smartphones were to blame for the poor accuracy, she said in an e-mail interview.

Ms. Sheikh reported that the investigators in the SleepMapper study had no disclosures. Dr. Aloia works for Philips Healthcare, which markets SleepMapper. Dr. Ferraris reported having no disclosures.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

A free app to help patients with obstructive sleep apnea become accustomed to using continuous positive airway pressure improved adherence during the first 11 weeks of therapy in a randomized, controlled trial with 61 patients.

The mean percentage of nights in which patients used continuous positive airway pressure (CPAP) for at least 4 hours was significantly higher in the 30 patients randomized to usual care plus use of the SleepMapper app (54%), compared with the 31 patients in the control group who got usual care alone (37%), Karen Sheikh reported at the annual meeting of the Associated Professional Sleep Societies in Minneapolis.

Courtesy of Philips Respironics, Murrysville, Penn.

Patients in the app group also used the CPAP device for significantly more nights, compared with the control group – an average of 78% of nights vs. 55%, respectively, said Ms. Sheikh of the research arm of Linthicum, Md.–based Respira, a durable medical equipment company that sponsored the study. Dr. Jordanna M. Hostler of Walter Reed National Medical Center, Bethesda, Md., led the study, which was conducted at Walter Reed (Sleep 2014;37:A106-7).

All patients used the same kind of CPAP equipment and were introduced to the therapy through a 4-hour group session, lectures giving an overview of obstructive sleep apnea, CPAP, and good sleep habits, and a follow-up appointment with a respiratory therapist 30 days later, according to Ms. Sheikh.

The 17% improvement in the SleepMapper group, compared with the control group, in nights in which CPAP was used for at least 4 hours was seen after the influences of maximum PAP pressure and sleep efficiency were controlled for, she reported.

The app can be used with any CPAP equipment made by Philips, the company that developed SleepMapper, according to Mark S. Aloia, Ph.D. In addition to providing information about PAP devices, the app individualizes feedback for patients about their adherence using algorithms based on psychological theories of behavior change.

SleepMapper also performed well in a separate retrospective study of 15,242 patients released by Philips. Compared with 7,601 patients who received standard care without the app, the 7,641 patients using SleepMapper were significantly more likely to be adhering to CPAP therapy in the first 90 days of therapy (78% vs. 56%, respectively).

Among the 12% of app users and 32% of the control group who were considered "struggling users" because they used CPAP an average of fewer than 2 hours per night during the first 2 weeks, 33% of strugglers in the app group and 11% of strugglers in the control group went on to meet CPAP adherence criteria set by the Centers for Medicare & Medicaid Services, according to Philips.

"We are confident that our study demonstrates that SleepMapper can improve patient lives at a population level," Dr. Aloia of Denver, who is senior director of global clinical research for Philips Healthcare, said in an e-mail interview.

Other sleep-related apps – and there are thousands – may not be as effective.

Pulmonologist Ambra Ferraris reported in a separate presentation at the Sleep 2014 meeting that results from the Sleep Time app (by Azumio) for iPhones did not correlate with in-laboratory polysomnography results in a pilot trial in 12 healthy volunteers. The Sleep Time app is not accurate enough for clinical use, suggested Dr. Ferraris of the New Jersey Neuroscience Institute at JFK Medical Center, Seton Hall University, South Orange, N.J.

The Sleep Time app (free or $1.99 version) uses the iPhone’s accelerometer to detect the sleeper’s movements during the night and claims to adjust the wake-up time that the user has set in the phone’s alarm clock so that the alarm goes off during the lightest sleep phase and the person wakes up refreshed instead of groggy.

In the study, volunteers simultaneously used the app and underwent polysomnography in the lab. There was no correlation between the two sets of results for sleep efficiency, percentage of light or deep sleep, or sleep latency, according to Dr. Ferraris's abstract. The app’s overall accuracy was 46% (Sleep 2014;37:A367-8), though it’s unclear whether the app or the smartphones were to blame for the poor accuracy, she said in an e-mail interview.

Ms. Sheikh reported that the investigators in the SleepMapper study had no disclosures. Dr. Aloia works for Philips Healthcare, which markets SleepMapper. Dr. Ferraris reported having no disclosures.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

Several new mobile applications and platforms for managing diabetes will be announced at the American Diabetes Association annual scientific sessions in San Francisco this month, and the results of a handful of trials of apps will be reported there. As a prelude, it’s helpful to know what’s been reported about diabetes apps previously.

Diabetes management has been one of the most talked-about goals of app development, given the immense costs in patients’ lives and in health care dollars from the disease. Although there are more than 1,000 specific diabetes apps for iOS and Android devices, only 1.2% of people with diabetes who have a smartphone or tablet use these apps, according to the Germany-based market research and consultancy firm research2guidance. The company expects that to grow to 7.8% (24 million people) by 2018. As of now, few diabetes apps incorporate seven standards for quality and functionality, or include them only at the most basic level, according to a recent report for sale on the company’s website.

German investigators analyzed information for 656 currently available diabetes apps and used a representative 65 of them to evaluate their usability for patients aged 50 years or older. Most were for English speakers (85%), and 54% were free, with no clear differences in user ratings between free and paid apps. The majority of apps offered just one function (54%), and only 5% offered an interface to a measurement device such as a glucometer. For older patients, the usability of the 65 tested apps was moderate to good but worsened if the app offered more than one function, especially documentation or analysis functions (J. Med. Internet Res. 2014;16:e101).

A Cochrane meta-analysis of data from 16 randomized controlled trials of Internet-based self-management interventions involving 3,578 adults with type 2 diabetes found 1-12 months of use reduced hemoglobin A_1c (HbA_1c) levels by 0.2%, compared with HbA_1c levels in control groups. Results were somewhat better, however, in the three trials of mobile phone-based interventions, which reduced HbA_1c levels by 0.5%, compared with controls. The other interventions studied were on computers or a touch-screen in homes or clinics (Cochrane Database Syst. Rev. 2013 March 28;3[doi:10.1002/14651858.CD008776.pub2]).

An earlier meta-analysis of results from a variety of mobile phone interventions in 15 studies involving a total of 929 children and adults with diabetes suggested overall benefits in managing blood glucose and HbA_1c levels, adhering to medical therapy, and maintaining a healthy lifestyle. The 12 trials that measured HbA_1c levels showed an average 0.4% reduction after 1-12 months of the intervention, compared with before (J. Mob. Technol. Med. 2012;1:17-24).

Combining usual care with use of the Glucose Buddy smartphone app and weekly text-message feedback from a diabetes educator significantly reduced HbA_1c levels, compared with usual care alone, in a randomized controlled trial of 72 Australians with type 1 diabetes. Among 53 patients who completed the 6-month intervention and 3-month follow-up, HbA_1c levels decreased from 9% at baseline to 7.8% in the 25 patients in the intervention group and increased from 8.5% at baseline to 8.6% in the control group of 28 patients (J. Med. Internet Res. 2013;15:e235).

A recent pilot study found that 60 adults with diabetes were enthusiastic about using the free SightBook app to monitor visual acuity changes at home but suggested that improvements will be needed to incorporate such apps into existing electronic medical records if they are to facilitate coordination between patients, diabetologists, and ophthalmologists in managing the risk of diabetic retinopathy (J. Diabetes Sci. Technol. 2014 April 14 [doi:10.1177/1932296814529637]).

Several trials have looked at text message–based interventions, including one that found no significant difference in HbA_1c levels but found improved medication adherence in 128 adults with poorly controlled diabetes who often relied on emergency departments for care. The effects were larger among Spanish speakers (Ann. Emerg. Med. 2014;63:745-54). A separate randomized controlled trial found that patients receiving text-message reminders when they forgot their diabetes medication took significantly more doses within 1 hour and 4 hours of the appropriate time (Int. J. Med. Inform. 2012;81:594-604).

Health care professionals who want to guide patients seeking to use diabetes apps may want to consider some key factors, a recent article suggested. These may include the age of the patient, the cost of the technology, the fact that most apps work only on Apple operating systems, and whether the app includes features such as blood glucose logging, nutritional databases or tracking, physical activity trackers, data sharing and social support, and text-message reminders. Patients should try using an app for at least a couple of weeks before judging it and be reminded that these are adjuncts, not substitutes for regular visits with their physician, the authors wrote (Diabetes Spectr. 2013;26:211-5).

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

Several new mobile applications and platforms for managing diabetes will be announced at the American Diabetes Association annual scientific sessions in San Francisco this month, and the results of a handful of trials of apps will be reported there. As a prelude, it’s helpful to know what’s been reported about diabetes apps previously.

Diabetes management has been one of the most talked-about goals of app development, given the immense costs in patients’ lives and in health care dollars from the disease. Although there are more than 1,000 specific diabetes apps for iOS and Android devices, only 1.2% of people with diabetes who have a smartphone or tablet use these apps, according to the Germany-based market research and consultancy firm research2guidance. The company expects that to grow to 7.8% (24 million people) by 2018. As of now, few diabetes apps incorporate seven standards for quality and functionality, or include them only at the most basic level, according to a recent report for sale on the company’s website.

German investigators analyzed information for 656 currently available diabetes apps and used a representative 65 of them to evaluate their usability for patients aged 50 years or older. Most were for English speakers (85%), and 54% were free, with no clear differences in user ratings between free and paid apps. The majority of apps offered just one function (54%), and only 5% offered an interface to a measurement device such as a glucometer. For older patients, the usability of the 65 tested apps was moderate to good but worsened if the app offered more than one function, especially documentation or analysis functions (J. Med. Internet Res. 2014;16:e101).

A Cochrane meta-analysis of data from 16 randomized controlled trials of Internet-based self-management interventions involving 3,578 adults with type 2 diabetes found 1-12 months of use reduced hemoglobin A_1c (HbA_1c) levels by 0.2%, compared with HbA_1c levels in control groups. Results were somewhat better, however, in the three trials of mobile phone-based interventions, which reduced HbA_1c levels by 0.5%, compared with controls. The other interventions studied were on computers or a touch-screen in homes or clinics (Cochrane Database Syst. Rev. 2013 March 28;3[doi:10.1002/14651858.CD008776.pub2]).

An earlier meta-analysis of results from a variety of mobile phone interventions in 15 studies involving a total of 929 children and adults with diabetes suggested overall benefits in managing blood glucose and HbA_1c levels, adhering to medical therapy, and maintaining a healthy lifestyle. The 12 trials that measured HbA_1c levels showed an average 0.4% reduction after 1-12 months of the intervention, compared with before (J. Mob. Technol. Med. 2012;1:17-24).

Combining usual care with use of the Glucose Buddy smartphone app and weekly text-message feedback from a diabetes educator significantly reduced HbA_1c levels, compared with usual care alone, in a randomized controlled trial of 72 Australians with type 1 diabetes. Among 53 patients who completed the 6-month intervention and 3-month follow-up, HbA_1c levels decreased from 9% at baseline to 7.8% in the 25 patients in the intervention group and increased from 8.5% at baseline to 8.6% in the control group of 28 patients (J. Med. Internet Res. 2013;15:e235).

A recent pilot study found that 60 adults with diabetes were enthusiastic about using the free SightBook app to monitor visual acuity changes at home but suggested that improvements will be needed to incorporate such apps into existing electronic medical records if they are to facilitate coordination between patients, diabetologists, and ophthalmologists in managing the risk of diabetic retinopathy (J. Diabetes Sci. Technol. 2014 April 14 [doi:10.1177/1932296814529637]).

Several trials have looked at text message–based interventions, including one that found no significant difference in HbA_1c levels but found improved medication adherence in 128 adults with poorly controlled diabetes who often relied on emergency departments for care. The effects were larger among Spanish speakers (Ann. Emerg. Med. 2014;63:745-54). A separate randomized controlled trial found that patients receiving text-message reminders when they forgot their diabetes medication took significantly more doses within 1 hour and 4 hours of the appropriate time (Int. J. Med. Inform. 2012;81:594-604).

Health care professionals who want to guide patients seeking to use diabetes apps may want to consider some key factors, a recent article suggested. These may include the age of the patient, the cost of the technology, the fact that most apps work only on Apple operating systems, and whether the app includes features such as blood glucose logging, nutritional databases or tracking, physical activity trackers, data sharing and social support, and text-message reminders. Patients should try using an app for at least a couple of weeks before judging it and be reminded that these are adjuncts, not substitutes for regular visits with their physician, the authors wrote (Diabetes Spectr. 2013;26:211-5).

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

Several new mobile applications and platforms for managing diabetes will be announced at the American Diabetes Association annual scientific sessions in San Francisco this month, and the results of a handful of trials of apps will be reported there. As a prelude, it’s helpful to know what’s been reported about diabetes apps previously.

Diabetes management has been one of the most talked-about goals of app development, given the immense costs in patients’ lives and in health care dollars from the disease. Although there are more than 1,000 specific diabetes apps for iOS and Android devices, only 1.2% of people with diabetes who have a smartphone or tablet use these apps, according to the Germany-based market research and consultancy firm research2guidance. The company expects that to grow to 7.8% (24 million people) by 2018. As of now, few diabetes apps incorporate seven standards for quality and functionality, or include them only at the most basic level, according to a recent report for sale on the company’s website.

German investigators analyzed information for 656 currently available diabetes apps and used a representative 65 of them to evaluate their usability for patients aged 50 years or older. Most were for English speakers (85%), and 54% were free, with no clear differences in user ratings between free and paid apps. The majority of apps offered just one function (54%), and only 5% offered an interface to a measurement device such as a glucometer. For older patients, the usability of the 65 tested apps was moderate to good but worsened if the app offered more than one function, especially documentation or analysis functions (J. Med. Internet Res. 2014;16:e101).

A Cochrane meta-analysis of data from 16 randomized controlled trials of Internet-based self-management interventions involving 3,578 adults with type 2 diabetes found 1-12 months of use reduced hemoglobin A_1c (HbA_1c) levels by 0.2%, compared with HbA_1c levels in control groups. Results were somewhat better, however, in the three trials of mobile phone-based interventions, which reduced HbA_1c levels by 0.5%, compared with controls. The other interventions studied were on computers or a touch-screen in homes or clinics (Cochrane Database Syst. Rev. 2013 March 28;3[doi:10.1002/14651858.CD008776.pub2]).

An earlier meta-analysis of results from a variety of mobile phone interventions in 15 studies involving a total of 929 children and adults with diabetes suggested overall benefits in managing blood glucose and HbA_1c levels, adhering to medical therapy, and maintaining a healthy lifestyle. The 12 trials that measured HbA_1c levels showed an average 0.4% reduction after 1-12 months of the intervention, compared with before (J. Mob. Technol. Med. 2012;1:17-24).

Combining usual care with use of the Glucose Buddy smartphone app and weekly text-message feedback from a diabetes educator significantly reduced HbA_1c levels, compared with usual care alone, in a randomized controlled trial of 72 Australians with type 1 diabetes. Among 53 patients who completed the 6-month intervention and 3-month follow-up, HbA_1c levels decreased from 9% at baseline to 7.8% in the 25 patients in the intervention group and increased from 8.5% at baseline to 8.6% in the control group of 28 patients (J. Med. Internet Res. 2013;15:e235).

A recent pilot study found that 60 adults with diabetes were enthusiastic about using the free SightBook app to monitor visual acuity changes at home but suggested that improvements will be needed to incorporate such apps into existing electronic medical records if they are to facilitate coordination between patients, diabetologists, and ophthalmologists in managing the risk of diabetic retinopathy (J. Diabetes Sci. Technol. 2014 April 14 [doi:10.1177/1932296814529637]).

Several trials have looked at text message–based interventions, including one that found no significant difference in HbA_1c levels but found improved medication adherence in 128 adults with poorly controlled diabetes who often relied on emergency departments for care. The effects were larger among Spanish speakers (Ann. Emerg. Med. 2014;63:745-54). A separate randomized controlled trial found that patients receiving text-message reminders when they forgot their diabetes medication took significantly more doses within 1 hour and 4 hours of the appropriate time (Int. J. Med. Inform. 2012;81:594-604).

Health care professionals who want to guide patients seeking to use diabetes apps may want to consider some key factors, a recent article suggested. These may include the age of the patient, the cost of the technology, the fact that most apps work only on Apple operating systems, and whether the app includes features such as blood glucose logging, nutritional databases or tracking, physical activity trackers, data sharing and social support, and text-message reminders. Patients should try using an app for at least a couple of weeks before judging it and be reminded that these are adjuncts, not substitutes for regular visits with their physician, the authors wrote (Diabetes Spectr. 2013;26:211-5).

sboschert@frontlinemedcom.com

On Twitter @sherryboschert