Use of an Insulin-Only Bionic Pancreas Effectively Controls Blood Glucose Levels

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Jun 11, 2016, 11:48 ET

NEW ORLEANS, June 11, 2016 /PRNewswire-USNewswire/ -- Use of an insulin-only bionic pancreas effectively controls blood glucose levels, with no difference in episodes of hypoglycemia (low blood glucose levels), compared to a bihormonal (insulin plus glucagon) bionic pancreas, when both insulin-only and bihormonal configurations used a target blood sugar of 130 mg/dl, according to a study presented at the American Diabetes Association's 76th Scientific Sessions^® at the Ernest N. Morial Convention Center in New Orleans.

Previous studies have demonstrated that a bihormonal bionic pancreas can effectively manage blood glucose levels in people with type 1 diabetes, with minimal episodes of hypoglycemia. In this study, an insulin-only bionic pancreas using the same insulin-dosing algorithm as a bihormonal bionic pancreas, but configured with a higher glucose target than the 100 mg/dl used in all previous bionic pancreas trials, was tested to determine if it could both effectively control blood glucose levels and maintain low rates of hypoglycemia.

In this random-order, crossover study, two insulin-only configurations of the bionic pancreas (at glucose targets of 130 mg/dl and 145 mg/dl) were compared to three bihormonal configurations (insulin and glucagon; glucose target of 130 mg/dl, 115 mg/dl, and 100 mg/dl) and to usual care (patient-managed, conventional insulin pump therapy) over the course of three days. A total of 20 subjects (9 males and 11 females) completed the study. The age range was between 20 and 77 years old. During the 72-hour study, participants were allowed to perform normal daily activities with no limitations on diet or exercise. Hypoglycemia was defined as the percentage of time spent with blood glucose levels less than or equal to 60 mg/dl.

The study found that raising the blood glucose target to 130 mg/dl increased the mean glucose achieved by the bihormonal bionic pancreas (156±12 mg/dl in the 130 mg/dl configuration vs. 146±15 mg/dl in the 115 mg/dl target configuration vs. 136±14 mg/dl in the 100 mg/dl configuration, p≤0.016 for each comparison). When a target glucose of 130 mg/dl was used there was no significant difference between the mean glucose achieved by the insulin-only configuration and the bihormonal configuration of the bionic pancreas (161±17 mg/dl vs.156±12 mg/dl, p>0.28, respectively), and no difference in hypoglycemia between the two bionic pancreas configurations (0.8±1.4% vs. 0.6±1.0%, p>0.28).Likewise, both bionic pancreas configurations at the 130 mg/dl target had similar mean glucose and hypoglycemia vs. the usual care arm (158±31 mg/dl, 1.4±2.6%, p>0.28 for all comparisons). Mean glucose levels for the insulin-only bionic pancreas with a target of 145 mg/dl were higher (174±23 mg/dl) than all other arms (p<0.034 for all comparisons), and raising the glucose target did not result in a reduction in hypoglycemia (1.0±1.5%, p>0.28 for all comparisons). Total daily insulin dose for all of the bionic pancreas arms was similar (insulin-only with set point of 145 mg/dl: 0.56±0.21 U/kg, insulin-only with set point of 130 mg/dl: 0.57±0.19, bihormonal with set point of 130 mg/dl: 0.53±0.16).

"We were encouraged to find that the insulin-only bionic pancreas was safe, with minimal hypoglycemia. However, we'd like to see whether we can safely achieve a lower mean glucose with the insulin-only system while still maintaining low levels of hypoglycemia," said lead study author Laya Ekhlaspour, MD, a clinical and research fellow in pediatric endocrinology at Massachusetts General Hospital for Children, Boston. "With this mind, we are now investigating an insulin-only bionic pancreas with a glucose target lower than 130 mg/dl (110 mg/dl) in order to find the glucose target that will provide the best balance between mean glucose and hypoglycemia in the insulin-only configuration."

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.

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?
Oral Presentation: La Nouvelle Orleans AB
Session Time: Saturday, June 11, 2016, 8 a.m.–10 a.m.

79-OR Outpatient Glycemic Management in Type 1 Diabetes with Insulin-Only vs. Bihormonal Configurations of a Bionic Pancreas

LAYA EKHLASPOUR, FIRAS ELKHATIB, COURTNEY BALLIRO, RAJENDRANATH SELAGAMSETTY, ARYAN ESMAEILI, MALLORY HILLARD, DEBBIE MONDESIR, STEVEN J. RUSSELL, EDWARD R. DAMIANO, Boston, MA

Previous studies have shown that a bihormonal bionic pancreas (BP) is capable of effective glucose regulation with minimal hypoglycemia. We hypothesized that an insulin-only configuration of the BP using the same insulin dosing algorithm could also achieve effective glycemic control, but that a higher glucose target than the 100 mg/dl value used in previous trials should be used to minimize hypoglycemia. In a random order cross-over study we compared two insulin-only configurations of the BP (glucose targets of 130 and 145 mg/dl) with a bihormonal configuration (glucose target of 130 mg/dl), and usual care (patient managed insulin pump therapy). Subjects went about their daily routines with no limitations on diet or exercise during each 3-day test period. The co-primary outcomes were the mean continuous glucose monitor (CGM) glucose level and time <60 mg/dl during days 2-3 of each arm.
There was no significant difference in aggregate mean CGM glucose and time <60 mg/dl between the bihormonal 130 mg/dl target configuration (156±12 mg/dl, 0.6±1.0%), the insulin-only 130 mg/dl target configuration (161±17 mg/dl, 0.8±1.4%), and usual-care (158±31 mg/dl, 1.4±2.6%) - all p-values were >0.10. The mean CGM glucose for the insulin-only 145 mg/dl target configuration was higher (174±23 mg/dl) than both 130 mg/dl target configurations and than usual care (p-values 0.0014, <0.0001, and 0.034, respectively) with no significant reduction in time <60 mg/dl (1.0±1.5%, all p-values were >0.28). There were no significant differences in insulin total dose between any of the bionic pancreas arms.
The insulin-only and bihormonal configurations of the BP with targets of 130 mg/dl both performed similarly to usual care with low levels of hypoglycemia. The mean glucose was increased with a glucose target of 145 mg/dl without a compensatory decrease in hypoglycemia. The performance of insulin-only BP configurations with glucose targets lower than 130 mg/dl should be explored.

Author Disclosure Block:
L. Ekhlaspour: None. F. Elkhatib: None. C. Balliro: None. R. Selagamsetty: None. A. Esmaeili: None. M. Hillard: None. D. Mondesir: None. S.J. Russell: Advisory Panel; Author; Tandem Diabetes Care, Inc., Campanion Medical. Consultant; Author; Sanofi U.S., Flexion Therapeutics. Research Support; Author; Eli Lilly and Company, Dexcom, Inc., Tandem Diabetes Care, Inc., Sweetspot Diabetes, International Biomedical, Abbott Diabetes Care Inc., Insulet Corporation, Medtronic MiniMed, Inc.. 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, Novo Nordisk A/S, Beta Bionics. E.R. Damiano: Research Support; Author; Eli Lilly and Company, Tandem Diabetes Care, Inc., Dexcom, Inc., Sweetspot Diabetes, NOVA Biomedical. Other Relationship; Author; Eli Lilly and Company, Dexcom, Inc., Tandem Diabetes Care, Inc., Beta Bionics.