Omnipod® Hybrid Closed-Loop Insulin Delivery System Significantly Improves Glycemic Control in Adults with Type 1 Diabetes

ORLANDO, Fla., June 23, 2018 /PRNewswire-USNewswire/ -- Adults with type 1 diabetes using the Omnipod hybrid closed-loop system (the Horizon™ Automated Glucose Control System) were studied in a supervised outpatient hotel setting with unrestricted meals and moderate-intensity exercise and  experienced significantly less hypoglycemia, more time in the target glucose range and better overnight glycemic control compared to their usual care, according to the study, "Safety and Performance of the Omnipod Hybrid Closed-Loop System in Adults with Type 1 Diabetes over Five Days Under Free-Living Conditions," presented today at the American Diabetes Association's^® (ADA's) 78th Scientific Sessions^® at the Orange County Convention Center Convention Center.

For people with type 1 diabetes (T1D), continuous glucose monitoring (CGM) devices provide around-the-clock information on blood glucose levels, which is then used to determine how much insulin is needed. Insulin pumps allow the insulin doses to be administered subcutaneously throughout the day. The new Omnipod hybrid closed-loop (HCL) system combines the technology of CGM and insulin pumps, using continuous glucose monitoring and a personalized, model-predictive control algorithm to deliver insulin throughout the day and night.

This study assessed the safety and performance of the Omnipod hybrid closed-loop system in adults with T1D over five days in a supervised hotel setting under free-living conditions. The study included 11 adults aged 18-65 years with T1D, with an average age of 28.8 years and an average diabetes duration of 14.9 years. The participants' average HbA1c level was 7.4 and the average total daily dose of insulin was 0.67 U/kg. A seven-day phase of standard therapy, either continuous subcutaneous insulin infusion or multiple daily insulin injections, plus CGM use at home preceded the 96-hour HCL phase. Meals during the five-day HCL period were unrestricted, with participants making their own food choices and delivering insulin as they thought appropriate per their usual routine. Moderate-intensity exercise was performed for at least 30 minutes each day.

The results showed that the amount of time spent in the target glucose range of 70-180 mg/dl was 11.2 percent higher during HCL compared to standard therapy overall (73.7 percent and 62.5 percent, respectively). The time in the target range was also 13.2 percent higher overnight, with 73.9 percent for HCL vs. 60.7 percent for standard therapy. The percentage of time spent in hypoglycemia (< 70 mg/dl) was reduced during HCL vs. standard therapy, both overall (1.9 percent and 5.1 percent, respectively) and overnight (0.7 percent and 5.7 percent, respectively).

"The Omnipod closed-loop system is an 'untethered' patch pump with no tubing, which is very attractive to some patients," said chief investigator Bruce A. Buckingham, MD, professor of pediatrics, endocrinology and diabetes at Stanford University School of Medicine.  "Previous studies showed that the Omnipod HCL algorithm was safe and performed well, and we were pleased to see that under free-living conditions it provides very good glucose control in a wide age range of subjects, especially overnight. Additionally, since the pump, sensor and transmitter are worn on the body at all times, the system has the potential to continue to function as a closed-loop system most of the time. The Omnipod can be very beneficial for people with type 1 diabetes, as it can function through many activities and allows patients to have full pump functions, like extended meal boluses and temporary basal rates, while using it."

The Omnipod closed-loop system is an investigational device, limited by United States law to investigational use, and manufactured by Insulet Corporation.

To speak with Dr. Buckingham, please contact the ADA Press Office on-site at the Orange County Convention Center on June 22 - 26, by phone at 407-685-4010 or by email at press@diabetes.org.

The American Diabetes Association's 78th Scientific Sessions, to be held June 22-26, 2018, at the Orange County Convention Center in Orlando, is the world's largest scientific meeting focused on diabetes research, prevention and care. During the five-day meeting, more than 16,000 health care professionals from around the world will have exclusive access to more than 3,000 original diabetes 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. Felicia Hill-Briggs, PhD, ABPP, President of Health Care and Education, will deliver her address, "The American Diabetes Association in the Era of Health Care Transformation," on Saturday, June 23, and Jane E.B. Reusch, MD, President of Medicine and Science, will present her address, "24/7/365 – Lifetime with Diabetes," on Sunday, June 24. In total, the 2018 Scientific Sessions includes 375 oral presentations; 2,117 poster presentations, including 47 moderated poster discussions; and 297 published-only abstracts. Join the Scientific Sessions conversation on social media using #2018ADA.

About the American Diabetes Association
Nearly half of American adults have diabetes or prediabetes; more than 30 million adults and children have diabetes; and every 21 seconds, another individual is diagnosed with diabetes in the U.S. Founded in 1940, the American Diabetes Association (ADA) is the nation's leading voluntary health organization whose mission is to prevent and cure diabetes, and to improve the lives of all people affected by diabetes. The ADA drives discovery by funding research to treat, manage and prevent all types of diabetes, as well as to search for cures; raises voice to the urgency of the diabetes epidemic; and works to safeguard policies and programs that protect people with diabetes. In addition, the ADA supports people living with diabetes, those at risk of developing diabetes, and the health care professionals who serve them through information and programs that can improve health outcomes and quality of life. For more information, please call the ADA 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). 

207-OR Safety and Performance of the Omnipod^® Hybrid Closed-Loop System in Adults with Type 1 Diabetes over Five Days Under Free-Living Conditions

78th Scientific Sessions
News Briefing: Advances in Technology, Saturday, June 23, 11:30 a.m. ET

Session Type: Oral Presentations
Session Title: Clinical Trials in Type 1 Diabetes
Location: W308
Session Time:Sunday, June 24, 2018, 2:15 pm - 4:15 pm
Presentation Number: 207-OR

BRUCE A. BUCKINGHAM, JENNIFER SHERR, GREGORY P. FORLENZA, THOMAS A. PEYSER, JOON BOK LEE, JASON B. OCONNOR, BONNIE DUMAIS, LAUREN M. HUYETT, JENNIFER E. LAYNE, TRANG T. LY, Palo Alto, CA, New Haven, CT, Aurora, CO, Billerica, MA

The safety and performance of the Omnipod® hybrid closed-loop (HCL) personalized model predictive control algorithm was assessed in adults with type 1 diabetes (T1D) using an investigational device over 5 days in a supervised hotel setting under free-living conditions. Eligible participants were aged 18-65.0 y with A1C <10.0% using CSII or MDI. A 7-day open-loop (OL) phase of standard therapy (CSII/MDI) plus CGM use at home preceded the 96 h HCL phase. Meals during HCL were unrestricted, with boluses administered per usual routine. Moderate-intensity exercise was performed for ≥30 min/d. An adaptive approach was used to update participant parameters after the first 48 h of HCL. Eleven participants (MDI n=3) studied were (mean ± SD): age 28.8 ± 7.9 y, diabetes duration 14.9 ± 6.9 y, A1C 7.4 ± 1.2% and TDD 0.67 ± 0.24 U/kg. Glycemic outcomes are reported in the table. The percentage of time 70-180 mg/dL was 11.2% higher during HCL compared to OL overall (HCL 73.7 ± 7.5 vs. OL 62.5 ± 16.0) and 13.2% higher overnight (HCL 73.9 ± 21.0 vs. OL 60.7 ± 21.8). A concomitant reduction in the percentage of time <70mg/dL during HCL vs. OL occurred both overall (HCL 1.9 ± 1.3 vs. OL 5.1 ± 4.8) and overnight (HCL 0.7 ± 1.1 vs. OL 5.7 ± 7.4). The Omnipod HCL algorithm was safe and performed well over 5 days of use in adults with T1D under free-living conditions with unrestricted meals and moderate-intensity exercise.

Author Disclosure Block: B.A. Buckingham: Advisory Panel; Self; ConvaTec Inc., Novo Nordisk Inc. Consultant; Self; Becton, Dickinson and Company, Tandem Diabetes Care, Inc. Research Support; Self; Dexcom, Inc., Insulet Corporation, Medtronic, Tandem Diabetes Care, Inc. J. Sherr: Advisory Panel; Self; Bigfoot Biomedical, Eli Lilly and Company, Insulet Corporation. Consultant; Self; Medtronic MiniMed, Inc. G.P. Forlenza: Advisory Panel; Self; Dexcom, Inc. Research Support; Self; Bigfoot Biomedical, Dexcom, Inc., Insulet Corporation, Medtronic, Novo Nordisk Inc., Tandem Diabetes Care, Inc. T.A. Peyser: Consultant; Self; Biolinq, Dexcom, Inc., Insulet Corporation. Employee; Self; ModeAGC. J. Lee: Employee; Self; Insulet Corporation. J.B. O'Connor: None. B. Dumais: Employee; Self; Insulet Corporation. L.M. Huyett: Employee; Self; Insulet Corporation. J.E. Layne: Employee; Self; Insulet Corporation. T.T. Ly: Employee; Self; Insulet Corporation.

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SOURCE American Diabetes Association