FDA Allows Implantable CGM to Integrate With Insulin Pumps

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<root generator="drupal.xsl" gversion="1.7"> <header> <fileName>167927</fileName> <TBEID>0C04FE8F.SIG</TBEID> <TBUniqueIdentifier>MD_0C04FE8F</TBUniqueIdentifier> <newsOrJournal>News</newsOrJournal> <publisherName>Frontline Medical Communications</publisherName> <storyname/> <articleType>2</articleType> <TBLocation>QC Done-All Pubs</TBLocation> <QCDate>20240503T181438</QCDate> <firstPublished>20240506T134609</firstPublished> <LastPublished>20240506T134609</LastPublished> <pubStatus qcode="stat:"/> <embargoDate/> <killDate/> <CMSDate>20240506T134609</CMSDate> <articleSource/> <facebookInfo/> <meetingNumber/> <byline>MIRIAM E. TUCKER</byline> <bylineText>MIRIAM E. TUCKER</bylineText> <bylineFull>MIRIAM E. TUCKER</bylineFull> <bylineTitleText/> <USOrGlobal/> <wireDocType/> <newsDocType/> <journalDocType/> <linkLabel/> <pageRange/> <citation/> <quizID/> <indexIssueDate/> <itemClass qcode="ninat:text"/> <provider qcode="provider:imng"> <name>IMNG Medical Media</name> <rightsInfo> <copyrightHolder> <name>Frontline Medical News</name> </copyrightHolder> <copyrightNotice>Copyright (c) 2015 Frontline Medical News, a Frontline Medical Communications Inc. company. All rights reserved. This material may not be published, broadcast, copied, or otherwise reproduced or distributed without the prior written permission of Frontline Medical Communications Inc.</copyrightNotice> </rightsInfo> </provider> <abstract/> <metaDescription>The US Food and Drug Administration (FDA) has designated the Eversense (Sensionics, Inc; Ascencia Diabetes Care) implanted continuous glucose monitor (CGM) an “</metaDescription> <articlePDF/> <teaserImage/> <teaser>The Eversense CGM joins Dexcom’s G6 and G7 and the Freestyle Libre 2 Plus in being compatible with multiple different branded insulin pumps.</teaser> <title>FDA Allows Implantable CGM to Integrate With Insulin Pumps</title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear/> <pubPubdateMonth/> <pubPubdateDay/> <pubVolume/> <pubNumber/> <wireChannels/> <primaryCMSID/> <CMSIDs/> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>endo</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>fp</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>im</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> </publications_g> <publications> <term canonical="true">34</term> <term>15</term> <term>21</term> </publications> <sections> <term canonical="true">39313</term> <term>37225</term> </sections> <topics> <term canonical="true">205</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>FDA Allows Implantable CGM to Integrate With Insulin Pumps</title> <deck/> </itemMeta> <itemContent> <p>The US Food and Drug Administration (FDA) has designated the Eversense (Sensionics, Inc; Ascencia Diabetes Care) implanted continuous glucose monitor (CGM) an “integrated CGM,” meaning it can be used in conjunction with <a href="https://emedicine.medscape.com/article/2089224-overview">insulin</a> pumps as part of an automated insulin delivery system (AID). </p> <p>The Eversense now joins Dexcom’s G6 and G7 and the Freestyle Libre 2 Plus in being compatible with multiple different branded insulin pumps as part of AID systems, and it is the only implantable one. <br/><br/>The sensor device is inserted under the skin of the patient’s upper arm by a healthcare provider and a transmitter is worn over it on the skin. The <a href="https://www.medscape.com/viewarticle/898418">FDA approved the Eversense</a> in June 2018 for 3-month use and in <a href="https://www.medscape.com/viewarticle/968365">February 2022 </a> for use up to 6 months. It is indicated for people with diabetes aged 18 years and older.<br/><br/>Fingerstick blood glucose measurements are still required for calibration once a day after day 21, when symptoms don’t match the CGM information, or when taking <a href="https://reference.medscape.com/drug/tetracycline-342550">tetracycline</a> medications. <br/><br/>According to Sensionics, the Eversense is “the most accurate CGM in the critical low glucose ranges with essentially no compression lows.” The latter refers to ‘false low’ alarms that sometimes occur when a person presses on the device, such as during sleep.<br/><br/>“As we look ahead, we are focused on progressing our partnership discussions and software developments, and look forward to providing more updates,” Sensionics said in a statement.<br/><br/><span class="end"/></p> <p> <em>A version of this article first appeared on <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/fda-allows-implantable-cgm-integrate-insulin-pumps-2024a10008fn">Medscape.com</a></span>.</em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>