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Acceptance of Advanced Technologies & Treatments for Diabetes

Is innovative telemedicine the answer to preventing and treating diabetes?

Every year the internationally held Advanced Technologies and Treatments for Diabetes (ATTD) is a unique and innovative conference that brings together the world’s leading researchers, clinical practitioners, and industrial and corporate professionals to exchange ideas and information regarding innovative technology to treat and prevent diabetes and associated complications. This year in Paris, the conference came together to share a lot of efficacy data that would allow patients with diabetes to monitor their glucose continuously and manage their insulin dosing automatically. Multiple organizations have shown their interests and ongoing studies have justified the practical acceptance of novel technologies and treatments.

T1D is a nonprofit organization that offers researchers access to aggregated clinical, biological, patient-reported outcomes and electronic health record data, all while fostering collaboration among patients, physicians, researchers, and industry. It organized a multi-center study within its clinic network and registered 226 patients with type 1 diabetes. The participants were offered a Dexcom G4 Continuous Glucose Monitoring System (CGM) with an enhanced algorithm, which they used for six months. In one study arm, 149 subjects were dosed with their insulin based on the CGM reading alone without first confirming with a blood glucose (BG) meter measurement and 77 subjects were required to confirm the CGM reading with a BG measurement before dosing insulin. The study confirmed that there was no difference in outcomes between the ones using only CGM and those using both CGM and BGM. Thus, the data confirmed FDA’s recent clearance of Dexcom G5 indication for insulin dosing and approved reimbursement of CGM by Medicare.

Another device, GlucoTrack® manufactured by Integrity Applications, is a noninvasive device for measuring glucose levels in type 2 diabetes and prediabetes. It is clipped onto the ear lobe. In one study, the company demonstrated the precision and accuracy of the GlucoTrack® Model DF-F with reducing impact of postprandial lagging effect during measurement. The key findings showed that its algorithm compensated for the tissue-lagging effect relative to BG changes during post-meal intake, significantly improved its accuracy at different post-meal states, and equalized accuracy for pre- and post-meal glucose readings. Also, the clinical accuracy measured by Consensus Error Grid (CEG) displayed 100% of the pre-prandial and 98.2% of the post-prandial readings in the A+B zones. Moreover, another study with the device demonstrated consistent glucose measurement repeatability between different GlucoTrack® devices and on each earlobe of the same subject. The repeatability is similar at all tested glucose ranges and postprandial time periods and the device average precision absolute relative difference (PARD) of 8.2% was equivalent or better than the independently reported PARD values of available CGMs.

Tempo Health, an Aspire Venture company introduced an adaptive artificial intelligence, A2I to manage blood glucose levels in diabetes. The device self-assembles and self-optimizes a vast number of algorithms to build the best possible adaptive algorithm. A small observational study performed with Netherlands-based Diabeter (one of Europe’s largest specialized treatment centers for type 1 diabetes in children and young adults), the Tempo Health system based on A2I, showed considerable increased time in range and decreased time in hypoglycemia compared to results obtained by an experienced team of doctors. On the other hand, Glytec is a cloud-based eGlycemic management system that allows providers to standardize processes and personalize treatment with significant clinical and financial improvement. In one study, A1C dropped from a baseline average of 10.2% to 7.7% at three months and 7.6% at six months. In another study, its use among 5,718 patients with subcutaneous insulin, the median time to target glucose was 0.8 days with BG readings at 67.9% between 70-180 mg/dL.

Tubeless insulin pump, Omnipod Horizon by Insulet, is a hybrid system. They conducted a 36-hour study with 24 adult participants with type 1 diabetes that included a modified version of Insulet’s Omnipod, a Dexcom® continuous glucose sensor, and Insulet’s personalized model predictive control algorithm. The hybrid closed-loop system resulted in significantly less time spent in hypoglycemic blood glucose range compared to ranges prior to the study. Patients’ target blood glucose control was achieved and maintained at 69% of the time over the course of the study and target blood glucose control was maintained at 90% during the overnight period. Another product by Valeritas, V-Go, is a wearable and disposable insulin delivery device that helps lowers A1c and optimum use of correct insulin dose in type 2 diabetes. A retrospective analysis of 107 patients (50 patients with V-Go and 57 patients with insulin pens) with similar baseline parameters evaluated A1c levels. The A1c levels between V-Go and insulin pen users leveled down by 1.96% and 1.23%, respectively. The V-Go users had fewer insulin doses than insulin pen users, with 56 versus 77 units a day, respectively (p <0.001). Additionally, insulin pen users went through 3.6 needle sticks per day while V-Go users required only one (p <0.001).

Lastly, advances in telemedicine and its mainstream adoption is an ongoing process that only time can tell how far it can go. Novel devices are being researched and discovered every day. Nemaura Medical Company recently showcased a still-in-development continuous glucose-monitoring patch, sugarBEAT. The device is needle-free, disposable, ~1 mm thick, and uses an electronic sensor to measure BG levels that is streamlined through bluetooth to a smartphone app. This shows how far we have advanced and how far we still have to go. Although, the outcomes of clinical trials look promising, experts have shown concerns regarding artificially increased engagement in clinical trial to a digital health intervention’s success.

Practice Pearls:

  • ATTD is an internationally held conference to share safety and efficacy data in the upcoming advancement of innovative technologies that would allow patients with diabetes to monitor their glucose continuously and manage their insulin dosing automatically.
  • FDA supported the advancement in telemedicine with the recent clearance of Dexcom G5 indication for insulin dosing and approved reimbursement of CGM by Medicare.
  • Healthcare providers should be aware of recent advancements in technologies and treatments of diabetes and help educate their patients in acceptance of these advancements.

References:

Applications, Inc. Integrity. GlucoTrack® Maker Presents Scientific Data Demonstrating Reliable Accuracy and Precision. PR Newswire: News Distribution, Targeting and Monitoring.  A Cision Co., 16 Feb. 2017. Web. 24 Feb. 2017.

http://www.prnewswire.com/news-releases/glucotrack-maker-presents-scientific-data-demonstrating-reliable-accuracy-and-precision-300408691.html

Aspire Ventures Announces Groundbreaking A2I Technology Use in Type 1 Diabetes Study. Marketwired. Aspire Ventures, 15 Feb. 2017. Web. 24 Feb. 2017.

http://www.marketwired.com/press-release/aspire-ventures-announces-groundbreaking-a2i-technology-use-in-type-1-diabetes-study-2196097.htm

Clinical Study Confirms Continuous Glucose Monitoring Is as Safe and Effective as Blood Glucose Monitoring. T1D Exchange. Unitio, 16 Feb. 2017. Web. 23 Feb. 2017. https://t1dexchange.org/pages/clinical-study-confirms-continuous-glucose-monitoring-is-as-safe-and-effective-as-blood-glucose-monitoring/

Gordone DR. First Feasibility Study on the Automated Glucose Control Algorithm Demonstrates Beneficial Results in Adults with Type 1 Diabetes. Business Wire. Insulet Corporation, 17 Feb 2017. Web. 24 Feb 2017. http://www.businesswire.com/news/home/20170217005019/en/Insulet-Presents-Strong-Omnipod%C2%AE-Horizon%E2%84%A2-Hybrid-Closed-Loop

MobilHealthNews. Roundup: News from the Advanced Technologies & Treatments for Diabetes Conference. MobiHealthNews. HIMSS Media, 17 Feb. 2017. Web. 23 Feb. 2017. http://www.mobihealthnews.com/content/roundup-news-advanced-technologies-treatments-diabetes-conference

Nemaura Medical Inc., to Present SugarBEAT® Poster at the Advanced Technologies and Treatments for Diabetes Symposium (ATTD) in Paris, February 16th 2017. Business Wire. Bashir Timol, 15 Feb. 2017. Web. 24 Feb. 2017. http://www.businesswire.com/news/home/20170215005502/en/Nemaura-Medical-present-sugarBEAT%C2%AE-Poster-Advanced-Technologies

Solutions. Glytec Systems. Glytec, 2017. Web. 24 Feb. 2017. http://www.glytecsystems.com/Solutions.html

Valeritas Presents Data Showing Greater Reductions in A1c and Insulin Dose with V-Go® Wearable Insulin Delivery Device Compared to Insulin Pen Devices in Patients with Type 2 Diabetes. P&T Community. Group Publishers, 16 Feb 2017. Web. 23 Feb 2017. https://www.ptcommunity.com/wire/valeritas-presents-data-showing-greater-reductions-a1c-and-insulin-dose-v-go-wearable-insulin