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Evidence-Based Diabetes Management July 2014

Sessions Highlight Strides in

Mary K. Caffrey
ADA 74th Scientific Sessions
“Are we there yet?” The opening line in the recent editorial in Diabetes Care,1 appearing just ahead of the 74th Scientific Sessions of the American Diabetes Association (ADA) in San Francisco, sums up the hopes of those in the type 1 diabetes mellitus (T1DM) community, as they await word that “artificial pancreas” technology nears FDA approval.

Results presented at ADA on June 15, 2014, show that not only is the technology improving, but also that it is advancing on multiple fronts. Competition is important to the T1DM community, and it is becoming apparent that patients will have choices. This could help drive down prices for devices when they reach the market. The “bionic pancreas” being developed by Edward Damiano, PhD, associate professor of biomedical engineering at Boston University, grabbed most of the attention, as results were simultaneously published in the New England Journal of Medicine.2 The article, which highlighted separate studies among adults and teenagers, showed increased glycemic control with the investigational technology, especially among the adults overnight. “At home” studies, the next important step in the road toward FDA approval, will start soon among several study groups. Sue A. Brown, MD, assistant professor in the Department of Medicine at the University of Virginia, said such a study will begin there in July 2014.

Current technology requires T1DM patients to use an insulin pump and a continuous glucose monitor (CGM), but the patient largely tells the pump what to do. Overnight insulin regulation can remain tricky. Systems under study involve the use of specially programmed smartphones, which run algorithms that finely regulate release of insulin, more closely resembling what occurs in a person with a healthy pancreas. The Boston University model also dispenses the hormone glucagon, which commenters told The New York Times was a “clear advance.”3

Persons with T1DM and their advocates seemed to react favorably to the developments at the ADA conference. By contrast, some reacted negatively last fall when Medtronic, Inc used the term “artificial pancreas” to unveil its Minimed 530G with Enlite, whose “threshold suspend” technology was described by the company and in news reports as a major step forward in glycemic control.4 However, in the view of many T1DM patients, the device did not represent an advance worthy of the “artificial pancreas” label.

That experience did not mute the anticipation at the San Francisco meeting, which saw hundreds crowd a small lecture hall for what was officially billed as highlights from the journal Diabetes Care. Two talks within the June 14, 2014, symposium, from William V. Tamborlane, MD, professor of pediatrics (endocrinology) at the Yale Diabetes Research Center, and Boris Kovatchev, PhD, professor in the Department of Psychiatry and Neurobehavioral Science and director of the University of Virginia’s Center for Diabetes Technology, filled an overflow room and left dozens camped out in the hallways to watch the proceedings on a small screen.

Results that were published online ahead of the ADA sessions show that closed-loop technology of diabetes being developed at the University of Virginia trimmed the number of hypoglycemic episodes without adverse events.5 Kovatchev’s presentation featured photos of laptops that were running the insulin-regulating algorithms for the emerging technology only 4 years ago. Today’s smartphones do the job in a more convenient package.

Would this mean that persons with T1DM could soon manage their disease with the same portable device that most people carry in their pocket? Brown indicated this is possible. She said the phones used in clinical trials are disabled for other functions only because that’s what FDA protocols require.

Some T1DM patients who took part in the University of Virginia trial in January are also well-known bloggers, and they did more to generate buzz than any marketing campaign ever could.6 Kovatchev, whose center has received significant funding from the National Institutes of Health to work on artificial pancreas technology,7 offered this progress report June 14, 2014: algorithms,
which decide how much insulin to deliver, are ready. The technology is almost ready, but needs some fine-tuning.

What’s left is putting the devices into clinical settings on a broad basis, which will generate the results that FDA must evaluate before giving approval. That’s what the “at home” tests will do next.
Artificial pancreas technology has raced forward since 2012, when the FDA published its road map outlining what the agency needed to see for approval.8

Boston University results. Results were published from 2 studies involving 20 adults and 32 adolescents with T1DM who wore a “bionic pancreas” for 5 days. Instead of the patient  programming insulin delivery, the device was managed by an algorithm, which received data from a CGM and automatically controlled subcutaneous delivery of insulin and glucagon. In the adult study, the mean plasma glucose level during the study period was 138 mg/dL, and the mean percentage of time with a low glucose level (<70 mg/dL) was 4.8%. After using the device for 1 day, mean glucose levels were lower than mean levels during the control period (133 ± 13 vs 150 ± 30 mg/dL, P <.001.) Time with a low glucose reading was lower (4.1% vs 7.3%, P =.01). Among the adolescents, the mean plasma glucose level during the period using the device was also lower than during the control period (138 ± 18 vs 157 ± 27 mg/dL, P =.04), but the percentage of time with low glucose readings were similar (6.1% vs 7.6%, P =.23%). The authors reported significantly better control among the adults at night, and a reduction of more than 50% in the amount of carbohydrates given to treat hypoglycemia.2

University of Virginia results. Abstracts presented June 15, 2014, included results from a study of 10 adults, who stayed at a research “home” that is part of the university campus. The study’s aim was to fine-tune insulin delivery overnight, essentially “resetting” the patient to near normal glycemic levels.9 Brown said the technology aimed for an average 7 am reading of 120 mg/dL, and came in with an average of 119.3 mg/dL, compared with 152.9 mg/dL, P <.001, under standard care. And this happened using lower amounts of insulin, 6.1 units compared with 6.8 units, P =.1, under standard care. According to the study, improved glucose control carried over to the next day.
References.

1. Cefalu WT, Tamborlane WV. The artificial pancreas: are we there yet? Diabetes Care. 2014;37:1182-1183.

2. Russell SJ, El-Khatib FH, Sinha M. Outpatient glycemic control with a bionic pancreas in type 1 diabetes [published online June 15, 2014]. N Engl J Med. doi:10.1056/NEJMoa1314474.

3. Bakalar N. Artificial pancreas shows promise in diabetes test. The New York Times, June 15, 2014. http://www.nytimes.com/2014/06/16/us/artificial-pancreas-shows-promise-in-diabetes-test.html. Accessed July 16, 2014.

4. Introducing Minimed 530G with Enlite. Medtronic website. http://professional.medtronicdiabetes.com/minimed-530-g. Accessed June 15, 2014.

5. Ly TT, Breton MD, Keith-Hynes P, et al. Overnight glucose control with an automated, unified safety system in children and adolescents with type 1 diabetes at diabetes camp [published online May 30, 2014]. Diabetes Care. doi:10.2337/ dc14-0147.

6. Berg EG. The artificial pancreas aces new tests.Diabetes Forecast. http://www.diabetesforecast.org/2014/mar/the-artificial-pancreas-aces.html.Published March 2014. Accessed June 15, 2014.

7. UVA Receives $3.4 million NIH Grant for Artificial Pancreas Trial with 250 Participants in Network Closed-Loop System. diaTribe. http://diatribe.org/issues/60/new-now-next/5. Published January 21, 2014. Accessed June 15, 2014.

8. The artificial pancreas project. JDRF website.http://advocacy.jdrf.org/our-work/artificialpancreas-project/. Accessed June 15, 2014.

9. Brown SA, Brutomesso D, Breton MD, et al.Multi-night bedside artificial pancreas for patients with type 1 diabetes improves glycemic control. Diabetes. 2014;63(suppl 1): Abstract 104-LB.
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