Sessions Highlight Strides in "Artificial Pancreas" Technology

“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 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 approval.

Results presented Sunday show that not only is the technology improving, but it is also advancing on multiple fronts. That’s important to the T1DM community, as it becomes likely that patients will have choices, which could help drive down prices.

The “bionic pancreas” being developed by Boston University’s Edward Damiano, PhD, grabbed most of the attention, as results were simultaneously published in the New England Journal of Medicine.² The article highlighted separate studies among adults and teenagers and showed increased control, 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, said such a study will begin in July at the University of Virginia’s Center for Diabetes Technology.

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 smart phones, 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. By contrast, some pushed back hard last fall when Medtronic used the term “artificial pancreas” to unveil its Minimed 530G with Enlite,⁴ whose “threshold suspend” technology represented a step forward in glycemic control. 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 that Saturday symposium, from William Tamborlane, MD, of the Yale School of Medicine, and Boris Kovatchev, PhD, of the Center for Diabetes Technology at the University of Virginia, 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 Dr Kovatchev’s presentation featured photos of laptops that were running the insulin-regulating algorithms for the emerging technology only 4 years ago. Today’s smart phones do the job in a more pleasing package. Would this mean that someday, persons with T1DM could manage their disease with the same type of phone everyone else uses? Dr Brown indicated this is possible. She said the phones used in clinical trials are disabled for other functions simply because that’s what FDA protocols require.

Some T1DM patients who took part in 1 of the University of Virginia trials in January did more to generate buzz than any marketing campaign ever could.⁶ Dr Kovatchev, whose center has received significant funding from the National Institutes of Health to work on artificial pancreas technology,⁷ offered this progress report Saturday: 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. A study with adults produced better control than with their usual care, and “reduced the time that glucose levels were below 60 mg per deciliter by 67%” and by 94% during the overnight period. In a separate study with teenagers, study participants were more closely supervised, which the authors said may explain the “lack of significant between-group difference” in hypoglycemic episodes. Still, the NEJM article reported a reduction of more than 50% in the amount of carbohydrates given to treat hypoglycemia.²

University of Virginia results. Abstracts presented Sunday includes results from a study of 10 adults, who stayed at a research “home” that is part of the campus. The study’s aim was to fine-tune insulin delivery overnight, essentially “resetting” the patient to near normal glycemic levels.⁹ Dr 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 under standard care. And this happened using lower amounts of insulin, 6.1 units compared with 6.8 units 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. N Engl J Med. Published online June 15, 2014.
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. Diabetes Care. Published online ahead of print May 30, 2014.
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. diatTribe. 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/artificial-pancreas-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.