Home Use of a Dual Hormone, Bionic Pancreas Safely Reduces Blood Glucose Levels and Hypoglycemia in Adults While Continuing Normal Daily Activities

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Jun 11, 2016, 11:09 ET

NEW ORLEANS, June 11, 2016 /PRNewswire-USNewswire/ -- Use of a biohormonal, bionic pancreas in the home setting can safely and effectively lower mean blood glucose levels and hypoglycemia (low blood glucose), compared to the use of an insulin pump, in adults with type 1 diabetes performing normal daily activities, according to a study presented at the Association's 76th Scientific Sessions^®, June 11, 2016, at the Ernest N. Morial Convention Center in New Orleans.

This is the first study to test the efficacy and safety of a fully automated, dual hormone (glucagon and insulin) bionic pancreas for adults with type 1 diabetes over multiple days in a home setting, with no restrictions on diet and exercise. The findings are consistent with those of three previous outpatient studies of children and adults with type 1 diabetes by the same researchers in more supervised settings. In a pair of random-order, crossover studies in Boston, published in 2014[1], the team compared use of a bionic pancreas with that of an insulin pump over five days by 32 adolescents and camp counselors (ages 12-20) with type 1 diabetes in a summer camp setting and 20 adults (ages 21 years and older) who were shadowed by study staff during the day and restricted to a hotel at night. In a separate study published earlier this year[2], they compared the safety and effectiveness of the bionic pancreas to that of conventional insulin pump therapy when used by 19 pre-adolescent children (ages 6-11 years) with type 1 diabetes in a summer camp setting.

"These results, in addition to the results from our previous studies, suggest that the bionic pancreas, as an autonomous system, could profoundly reduce patient burden and provider involvement in type 1 diabetes management. At the same time, it could also offer significantly improved clinical outcomes in terms of reductions in both average blood sugar levels and hypoglycemia," said one of the lead investigators Edward R. Damiano, PhD, Professor of Biomedical Engineering, Boston University.

In this random order, crossover study, 39 adults (age 33 and older) with type 1 diabetes (of a mean duration 7±10 years) used the bionic pancreas for 11 consecutive days (intervention arm) and their own insulin pump (control arm) for the same amount of time to manage their diabetes while continuing their normal daily activities at home. Patients had a mean A1C of 7.7±1.2 percent at baseline.

During bionic pancreas use, a continuous glucose monitor provided data to an autonomously adaptive algorithm, which determined how much glucagon and insulin to deliver subcutaneously to the patient and when to deliver it. When using the insulin pump, patients managed insulin delivery on their own, following their normal insulin regimens. During the entire course of the study, patients were allowed to perform all normal daily activities, including driving and exercise, and were allowed to eat meals without caloric or carbohydrate restrictions.

Use of the bionic pancreas was associated with a 20 mg/dl decrease in average blood glucose levels (141±10 vs. 162±29 mg/dl, p<0.0001), compared to that of the insulin pump, and a threefold reduction in the percentage of time experiencing hypoglycemia, defined in this study as blood glucose levels below 60 mg/dl (1.9±1.7 vs. 0.6±0.6%, p<0.0001). Compared to use of the insulin pump, the bionic pancreas was also associated with fewer hypoglycemic events per day (0.59±0.56 vs. 0.90±0.64 events per day, p=0.023). The bionic pancreas was also associated with reductions in intersubject variability relative to insulin pump therapy in both average blood glucose levels and hypoglycemia.

"The cumulative results of our four studies suggest the bionic pancreas could potentially solve the four greatest concerns of type 1 diabetes management," continued Damiano. "First, the bionic pancreas reduces mean glycemia in nearly everyone to levels that would meet or exceed the American Diabetes Association's goal for therapy and could potentially nearly eradicate long-term microvascular and neurological complications, if implemented at the time of diagnosis. Second, it profoundly curtails mild hypoglycemia and could potentially eliminate the risk of severe hypoglycemia."

"Third, it automates glycemic management, thus unburdening people with type 1 diabetes of the active management needed to comply with therapy, as the bionic pancreas itself is the first technology we aware of that is entirely compliant with the patient's needs rather than the other way around. And finally, it relieves people with type 1 diabetes and their families of the emotional hardship of daily management, of the constant fear of hypoglycemia, and of the worry and dread of hyperglycemia."

"A device that solves any one of these concerns would be groundbreaking," Damiano concluded. "A device that simultaneously solves all four of these concerns is without precedent and represents a paradigm shift in clinical outcomes and type 1 diabetes management."

The American Diabetes Association's 76th Scientific Sessions, to be held June 10-14, 2016, at the Ernest N. Morial Convention Center in New Orleans, is the world's largest scientific meeting focused on diabetes. The 2016 Scientific Sessions is expected to attract more than 16,000 attendees and offers researchers and health care professionals from around the world the opportunity to share ideas and learn about the significant advances in diabetes research, treatment and care. During the five-day meeting, attendees receive exclusive access to more than 2,500 original research presentations, participate in provocative and engaging exchanges with leading diabetes experts, and can earn Continuing Medical Education (CME) or Continuing Education (CE) credits for educational sessions. The program is grouped into eight theme areas: Acute and Chronic Complications; Behavioral Medicine, Clinical Nutrition, Education and Exercise; Clinical Diabetes/Therapeutics; Epidemiology/Genetics; Immunology/Transplantation; Insulin Action/Molecular Metabolism; Integrated Physiology/Obesity; and Islet Biology/Insulin Secretion. Margaret A. Powers, PhD, RD, CDE, President, Health Care & Education, will deliver her address on Saturday, June 11, and Desmond Schatz, MD, President, Medicine & Science, will present his address on Sunday, June 12. The top eight abstracts of this year's Scientific Sessions will be presented on Tuesday, June 14, in the Presidents Oral Session. In total, the 2016 Scientific Sessions includes 378 abstracts in 50 oral sessions, 2,021 poster presentations including 59 moderated poster discussions, and 335 published-only abstracts. The Association's 2016 Scientific Achievement Awards and Lectures are:

Barbara B. Kahn, MD, Banting Medal for Scientific Achievement, the Association's highest honor. Kahn will deliver the Banting Medal Lecture, "Adipose Tissue, Inter-organ Communication, and the Path to T2D," on Sunday, June 12.
Tamas L. Horvath, DVM, PhD, Outstanding Scientific Achievement Award (OSAA), will present his OSAA Lecture, "Hunger-promoting Hypothalamic Neurons Control System Metabolism and Drive Complex Behaviors and Longevity," on Monday, June 13.
Sheri R. Colberg-Ochs, PhD, FACSM, Outstanding Diabetes Educator, will present her Lecture, "From Froot Loops^® to Fitness—My Journey as an Educator and PWD," on Saturday, June 11.
Edward W. Gregg, PhD, Kelly West Award for Outstanding Achievement in Epidemiology, will deliver his Lecture, "The Changing Tides of the Diabetes Epidemic—Smooth Sailing or Troubled Waters Ahead?," on Sunday, June 12.

Additional scientific research will be presented during 110 Symposia and nine Professional Interest Group sessions. The 76th Scientific Sessions also includes presence from more than 130 corporate and organizational exhibitors in nearly 100,000 square feet of exhibit space. Join the Scientific Sessions conversation on Twitter, #2016ADA.

[1] Russell SJ, El-Khatib FH, Sinha M, et al. Outpatient glycemic control with a bionic pancreas in type 1 diabetes. N Engl J Med 2014; 371:313-325.

[2] Russell SJ, Hilliard MA, Balliro C, et al. Day and night glycaemic control with a bionic pancreas versus conventional insulin pump therapy in preadolescent children with type 1 diabetes: a randomised crossover trial. The Lancet Diabetes & Endocrinology 2016; Vol. 4, No. 3: 233-243.

About the American Diabetes Association
The American Diabetes Association is leading the fight to Stop Diabetes^® and its deadly consequences and fighting for those affected by diabetes. The Association funds research to prevent, cure and manage diabetes; delivers services to hundreds of communities; provides objective and credible information; and gives voice to those denied their rights because of diabetes. Founded in 1940, the Association's mission is to prevent and cure diabetes, and to improve the lives of all people affected by diabetes. For more information, please call the American Diabetes Association at 1-800-DIABETES (1-800-342-2383) or visit diabetes.org. Information from both of these sources is available in English and Spanish. Find us on Facebook (American Diabetes Association), Twitter (@AmDiabetesAssn) and Instagram (@AmDiabetesAssn).

76th Scientific Sessions
News Briefing: Closed-Loop Systems, Friday, June 10, 1:00-1:45 p.m.

Oral Presentation: Closing the Loop on Insulin Management—Are We There Yet?
Poster Presentation: La Nouvelle Orleans AB
Session Time: Saturday, June 11, 2016, 8:00 a.m.–10:00 a.m. CT

77-OR Home Use of a Bihormonal Bionic Pancreas vs. Conventional Insulin Pump Therapy in Adults with Type 1 Diabetes—A Multicenter, Randomized Clinical Trial

FIRAS ELKHATIB, BRUCE A. BUCKINGHAM, JOHN B. BUSE, DAVID M. HARLAN, KENDRA MAGYAR, TRANG T. LY, M. SUE KIRKMAN, SAMIR MALKANI, MICHAEL J. THOMPSON, JOHN PAUL LOCK, LAYA EKHLASPOUR, PAULA CLINTON, JAIMIE DINER, MILANA DEZUBE, CELIA HARTIGAN, COURTNEY BALLIRO, RAJENDRANATH SELAGAMSETTY, ARYAN ESMAEILI, MANASI SINHA, MALLORY HILLARD, DEBBIE MONDESIR, EDWARD R. DAMIANO, STEVEN J. RUSSELL, Boston, MA, Stanford, CA, Chapel Hill, NC, Worcester, MA

The safety and effectiveness of continuous, multi-day, automated glycemic control using insulin and glucagon have not been tested in a home-use setting. We evaluated the efficacy of a bihormonal bionic pancreas versus conventional insulin pump therapy pancreas in adults with type 1 diabetes living at home and performing their normal activities without restrictions on diet or exercise. We performed a random-order cross-over study comparing glycemic regulation with a bihormonal bionic pancreas versus an insulin pump over 11 days each. During the bionic pancreas arm, data from a continuous glucose monitor was used by an autonomously adaptive algorithm to control subcutaneous delivery of insulin and glucagon. During the comparator arm, participants managed their own conventional insulin pump therapy. The co-primary outcomes were the mean glucose level and time <60 mg/dl by continuous glucose monitoring analyzed over days 2-11 in participants completing both arms of the study according to a modified intention-to-treat principle. The bionic pancreas was associated with a reduction in the mean glucose level (162±29 versus 141±10 mg/dl, p<0.0001) and reduced percent time <60 mg/dl (1.9±1.7 versus 0.6±0.6%, p<0.0001) relative to the comparator. Over the entire study period the bionic pancreas was associated with a reduction in the mean number of symptomatic hypoglycemia events per day (0.59±0.56 versus 0.90±0.64 events per day, p=0.023). The mean total daily dose (TDD) of insulin delivered by the bionic pancreas varied widely between participants and was ~6% greater during the bionic pancreas period than during the comparator period (0.66±0.15 versus 0.62±0.18 units/kg/day, p=0.01).The bionic pancreas was associated with a reduction in the mean glucose level and a reduction in hypoglycemia when compared to conventional insulin pump therapy in adults with type 1 diabetes living at home and participating in their normal daily activities.

Author Disclosure Block:
F. Elkhatib: VP, Product Development; Stock/Shareholder; Author; Beta Bionics, Inc. B.A. Buckingham: Research Support; Author; Medtronic, Inc. J.B. Buse: Consultant; Author; PhaseBio Pharmaceuticals, Inc.. Research Support; Author; AstraZeneca, Boehringer Ingelheim GmbH, Eli Lilly and Company, GI Dynamics, Inc., Johnson & Johnson, Lexicon Pharmaceuticals, Inc., Novo Nordisk Inc, Orexigen Therapeutics, Inc., Bristol-Myers Squibb Company. Stock/Shareholder; Author; Phase Bio. Other Relationship; Author; AstraZeneca, Dance Biopharm, Eli Lilly and Company, Elcelyx Therapeutics, Inc., GI Dynamics, Inc., Lexicon Pharmaceuticals, Inc., Merck & Co., Inc, Metavention, Novo Nordisk Inc, Orexigen Therapeutics, Inc., vTv Therapeutics. D.M. Harlan: None. K. Magyar: Other Relationship; Author; Tandem Diabetes Care, Inc. T.T. Ly: Research Support; Author; Medtronic, Inc. M. Kirkman: Research Support; Author; Novo Nordisk Inc. S. Malkani: None. M.J. Thompson: None. J. Lock: None. L. Ekhlaspour: None. P. Clinton: Consultant; Author; Johnson & Johnson Diabetes Institute. J. Diner: None. M. Dezube: None. C. Hartigan: None. C. Balliro: None. R. Selagamsetty: None. A. Esmaeili: None. M. Sinha: None. M. Hillard: None. D. Mondesir: None. E.R. Damiano: President and CEO; Stock/Shareholder; Author; Beta Bionics, Inc. S.J. Russell: Advisory Panel; Author; Tandem Diabetes Care, Inc., Campanion Medical. Consultant; Author; Sanofi U.S.. Other Relationship; Author; Sanofi U.S., Dexcom, Inc., Tandem Diabetes Care, Inc., Eli Lilly and Company, Abbott Diabetes Care Inc., Insulet Corporation, Medtronic MiniMed, Inc., International Biomedical.