Medtronic Makes News at ADA With 640G Results, Samsung  Partnership, Start of Pivotal Trial

The annual Scientific Sessions of the American Diabetes As-sociation (ADA) always serves as the year’s most important coming out party for makers of insulin pumps and continuous glucose monitoring (CGM) technology. The sessions offer an opportunity to share clinical trial results and prototypes of what’s in the pipeline, and device manufacturer Medtronic did some of each this year.

The ADA sessions offered a backdrop for Medtronic to announce partnerships with Glooko and Samsung,¹ as medical device makers increasingly collaborate with leaders in consumer technology. Advocates in the diabetes community have long called for products that not only provide better glycemic control with less patient interaction, but also are better designed and more discreet,² with the ability to share data on plat-forms such as smartphones or watches. Medtronic received pushback in September 2013 when it unveiled its MiniMed 530G with Enlite, describing the system, with its “threshold suspend” technology as a “first-generation” artificial pancreas system.³While Medtronic received recognition among those with type 1 diabetes mellitus (T1DM) for taking a genuine step forward, the use of the words “artificial pancreas” was viewed by some as an overreach in the case of this product.

By contrast, Medtronic received generally positive feedback from leading reviewers on the news it rolled out at ADA in Boston.^4,5 Besides the deal with Samsung and Glooko, the company announced:

• A user evaluation study for its MiniMed 640G system, the system that will succeed the 530G, which is currently available in Australia and Europe.

• Medtronic is enrolling patients in the first pivotal trial study of a hy-brid closed-loop system, which the company said “is designed to auto-matically control glucose levels 24 hours a day with less input from patients.”⁶

• FDA approval of MiniMed Connect, a data-sharing system for its insulin pump and CGM combination. Real-time data from 2 current Medtronic CGM systems can be connected to Medtronic’s CareLink software, with data uploaded to a smartphone. Family members—such as parents of children with T1DM—can get a text message in the event of blood sugar highs or lows. The system requires a small uploader device about the size of a thumb drive, which costs $199 and will be avail-able this fall.⁷

Results From the 640G. This advance features a technology called Smart-Guard, which has a feature called “suspend before low.” The next step after “threshold suspend,” it is designed to be forward looking, and stops insulin before the sensors show a glucose level falling below a preset low limit; the tech-nology also restarts the insulin delivery once glucose levels return to normal.

The study evaluated 40 adults and chil-dren with T1DM at 3 sites in Europe for 30 days. The mean age of the participants was 31 years, and participants had lived with T1DM an average of 17 years. In that period there were 2402 events in which insulin was suspended, including 2322 “suspend before low” and 80 “suspend on low.” In 83.1% of the “suspend before low” events, insulin levels did not reach the preset low limit. Four mild adverse events were reported: 2 skin reactions, a cold, and a urinary tract infection^.6,8

Francine Kaufman, MD, chief medical officer at Medtronic Diabetes, told Evidence-Based Diabetes Management before the ADA sessions that the predictive glucose management system in the 640G is the result of input from T1DM patients. “Rather than wait until you get to the threshold, we’ll stop the insulin in anticipation of where we’ll be 30 minutes from now,” she said in an interview. This “predictive horizon” concept keeps patients from ever ap-proaching a severe hypoglycemic episode, which can cause brain injury and even death.

As Kaufman explained, the 640G also allows patients with T1DM to adjust the insulin-suspension threshold at different times of day, depending on activity levels or food consumption. In terms of quality of life, these advances are a huge step forward, because they reduce the likelihood that patients will have a hypoglycemia episode at night while sleeping, which is a major concern of persons with T1DM.

While approval for 640G is the short-term goal, the pivotal trial is a more concrete step toward a closed-loop system. “We’re not going to stop until we get there,” Kaufman said.

Working With Glooko, Samsung. Medtronic’s announcement that it will partner with Glooko, a Cloud-based diabetes management platform developed in collaboration with Joslin Diabetes Center’s Howard Wolpert, MD, will reportedly lead to better integration of data from its insulin pumps and CGM devices with other related food and wellness data. Wolpert described the Glooko technology this spring at Patient-Centered Diabetes Care, a conference jointly presented by The American Journal of Managed Care and Joslin. He said caregivers and providers will be able to access the data via smart-phones, improving care management and making it possible to find out earlier about imminent hypoglycemia events.

Samsung’s involvement (both Med-tronic and Samsung have invested in Glooko)⁹ is aimed at tapping the company’s “deep understanding of consumer mobile technology,”¹ with the goal of creating CGM products that are more user-friendly—and less obviously medical devices. In a joint statement, the companies said that Android technology is used by 80% of smartphone users globally. References

1. Medtronic and Samsung partner to enhance diabetes management and empower overall patient health [press release]. http://newsroom. medtronic.com/phoenix.zhtml?c=251324&p=irol-newsArticle&ID=2056804. Boston, MA: Medtronic; June 5, 2015.

2. Tenderich A. An open letter to Steve Jobs. DiabetesMine website. http://www.healthline. com/health/diabetesmine/innovation/open-let-ter-steve-jobs. Published April 9, 2007. Accessed June 15, 2015.

3. Medtronic gains approval of first artifi-cial pancreas device system with thresh-old suspend automation [press release]. Minneapolis, MN: Medtronic; September 27, 2013. http://newsroom.medtronic. com/phoenix.zhtml?c=251324&p=irol-newsArticle&ID=1859361.

4. Tenderich A, Hoskins M. Tech spotting at the ADA Scientific Sessions 2015. Diabetes-Mine website. http://www.healthline.com/ diabetesmine/overview-ada-scientific-sessions-2015#1Insulin Nation. Published June 10, 2015. Accessed June 11, 2015.

5. Idlebrook C. FDA approves Medtronic’s MiniMed Connect. Insulin Nation website. http://insulinnation.com/devices/fda-approves-medtronics-minimed-connect/. Published June 5, 2015. Accessed June 11, 2015.

6. Medtronic accelerates path to artificial pan-creas with new MiniMed 640G data and start of hybrid closed loop trial [press release]. Boston, MA: Medtronic; June 6, 2015. http://newsroom. medtronic.com/phoenix.zhtml?c=251324&p=irol-newsArticle&ID=2056959.

7. Medtronic receives FDA clearance for Min-iMed Connect for more convenient access to personal diabetes data [press release]. Boston, MA: Medtronic; June 5, 2015. http://newsroom. medtronic.com/phoenix.zhtml?c=251324&p=irol-newsArticle&ID=2056803.

8. Choudhary P, Olsen BS, Conget I, et al. Perfor-mance of the predictive low glucose management feature of the MiniMed 640G system in a user evaluation study. Diabetes. 2015;64(suppl 1): abstract 1080-P.

9. Parmar A. Medtronic and Samsung just invested in this company. MDDI website. http:// www.mddionline.com/blog/devicetalk/medtron-ic-and-samsung-just-invested-company-03-17-15. Published March 17, 2015. Accessed June 18, 2015.