Feb 17,2017

Roundup: News from the Advanced Technologies & Treatments for Diabetes

Nonprofit organization T1D Exchange published a major study in Diabetes Care yesterday (and presented the research at the conference). The data re-affirms the FDA's recent clearance of Dexcom's CGM for insulin dosing. The study looked at 226 adult CGM users for six months. Of those, 149 dosed their insulin using the CGM and 77 used a fingerstick glucometer in addition, as is currently required for most CGMs. There was no difference in outcomes between the two groups.

CLINICAL STUDY

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Feb 01,2017

Performance of the FreeStyle Libre Flash glucose monitoring system in patients with type 1 and 2 diabetes mellitus

The research aims to evaluate the performance of the FreeStyle Libre Flash continuous glucose monitoring (FSL-CGM) system against established central laboratory methods. 20 subjects (8 type 1 diabetes mellitus, 12 type 2 diabetes mellitus) were analyzed. FSL-CGM sensor measurements (inserted in arm and abdomen) were compared with capillary blood glucose results analyzed with StatStrip as semigold standard. The glucose response after a standardized oral glucose load was measured by FSL-CGM and capillary samples analyzed by perchloric acid hexokinase (PCA-HK) method, StatStrip and FSL test strip (FSLC), and a commonly used CGM system (iPro2).

CLINICAL STUDY

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Feb 17,2017

Insulet Presents Strong Omnipod® Horizon™ Hybrid Closed-Loop Study Results at ATTD in Paris

Insulet Corporation, the leader in tubeless insulin pump technology with its Omnipod® Insulin Management System (Omnipod System), today announced positive results from the first feasibility study of the Omnipod Horizon™ hybrid closed-loop system. Study participants included 24 adults with type 1 diabetes. The 36-hour study1 included a modified version of Insulet's Omnipod, a Dexcom® continuous glucose sensor, and Insulet's personalized model predictive control algorithm. Results showed use of the Company's hybrid closed-loop system was associated with significantly less time spent in hypoglycemic blood glucose range compared to ranges prior to the study.

CLINICAL STUDY

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Mar 09,2017

Researchers build 4mm patch that monitors glucose from sweat, delivers drugs

As exciting as the near future of diabetes management is, with numerous efforts underway to perfect closed-loop CGM and pump systems for automated insulin delivery, the systems of the future could be even easier. A paper in Science Advances details the prototype for a 4 millimeter wearable patch that could not only noninvasively detect glucose levels from sweat, but also deliver the diabetes medication Metformin through microneedles in response to the sensor's readings.

CLINICAL STUDY

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Mar 24,2017

Medicare Announces Criteria Covering Dexcom G5 Mobile CGM for All People with Diabetes on Intensive Insulin Therapy

Dexcom is pleased to announce that the U.S. Centers for Medicare & Medicaid Services (CMS) has published an article clarifying criteria for coverage and coding of the Dexcom G5 Mobile system, the only therapeutic CGM under this CMS classification. People covered by Medicare who have either Type 1 or Type 2 diabetes and intensively manage their insulin will now be able to obtain reimbursement.

PRODUCT

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Apr 24,2017

Nemaura Medical Inc. successfully completes development of second-generation sugarBEAT® non-invasive Continuous Glucose Monitoring skin-patch.

Nemaura Medical Inc. (OTCBB: NMRD), a medical device company has today announced the successful completion of the development and testing of its second-generation sugarBEAT® wireless skin-patch as a non-invasive, needle-free Continuous Glucose Monitoring (CGM) system for use by diabetics. The first-generation sugarBEAT® received CE approval in Q1 2016, as a wired wrist-watch based non-invasive, needle-free CGM system.

PRODUCT

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May 12,2017

Senseonics, TypeZero partner on artificial pancreas research

Senseonics, a Germantown, Maryland company working on a pill-sized, implantable continuous glucose monitor that can last 90 days without needing replacement, will work with digital, personalized medicine company TypeZero Technologies on a project to integrate readings from Senseonics devices into TypeZero’s inControl software platform, which can either be used for decision support for manual insulin dosing or automatically adjust and regulate insulin delivery via an insulin pump. The two have signed an R&D licensing agreement.

COLLABORATION PARTNERSHIP

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Jun 01,2017

Glooko and Dexcom take relationship further with cloud integration

Digital diabetes management company Glooko and device maker Dexcom have expanded their partnership, effectively creating on-demand access to continuous glucose monitor data for both physicians and patients who use the two companies’ products. Glooko and Dexcom began working together in June 2015, when Glooko first began integrating CGMs and insulin pumps into its platform.

COLLABORATION PARTNERSHIP

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Jun 29,2017

Insulin delivery, workout routes, and more added to Apple HealthKit

Apple has upgraded its HealthKit app framework to provide more tracking options for people with diabetes. Insulin delivery is a big addition and one that shows that Apple is interested in being involved in “closed loop” diabetes interventions that include both glucose tracking and insulin dosing. HealthKit will track both basal and bolus insulin in units. Dexcom will take advantage of the Apple Watch’s native Bluetooth to allow users of Dexcom’s CGM to access their blood glucose data directly from the Watch, even if they’ve left their phone at home.

PRODUCT

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Jun 07,2017

Dexcom Announces FDA Approval of G5 Mobile App for Android Devices

Dexcom is pleased to announce the Food and Drug Administration (FDA) approval of the Dexcom G5 mobile app for Android devices. Beginning in June, Android users will have access to the free app for the Dexcom G5 Mobile CGM System, allowing people with diabetes to view and monitor their glucose levels on their mobile devices to manage their diabetes in real time. The Dexcom G5 Mobile CGM System is the first and only CGM platform available for Android in the United States, complementing the 2015 iOS launch.

REGULATORY FDA

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