Orlando, Florida - New research finds that people with type 1 diabetes (T1D) who used the Diabeloop DBLG1 therapeutic, closed-loop insulin delivery system in a home setting experienced a greater percentage of time in the target blood glucose range and fewer hypoglycemic events compared to patients who used an open-loop system, consisting of their regular pump and sensor. The findings from the study, “Twelve-Week Home Use of Hybrid Closed-Loop Insulin Delivery System vs. Sensor-Assisted Pump Therapy in Adults with Type 1 Diabetes—Intermediate Results of the Multicenter Randomized Crossover Diabeloop WP7 Trial,” were presented at the American Diabetes Association’s® (ADA’s) 78th Scientific Sessions® at the Orange County Convention Center Convention Center.
The Diabeloop DBLG1 system is an advanced, closed-loop insulin delivery system with a complex, customizable algorithm that predicts future blood glucose levels and instructs insulin delivery by connecting three devices: a glucose sensor, a patch insulin pump and a smartphone-like terminal device hosting the algorithm. The continuous glucose sensor monitors the user’s blood glucose level and sends data to the terminal, integrating the algorithm. The terminal controls the connected insulin pump by calculating and ordering the optimal amount of insulin. For maximum accuracy, users enter their food and physical activity information.
The goal of this new study, a follow-up to a 2016, three-day study, was to assess whether patients using the DBLG1 system could achieve better glucose control compared to sensor-assisted pump therapy in a home setting. The trial was conducted at 12 centers in France and enrolled 68 adults (average age 47.2 years) with T1D and an average HbA1c level of 7.6. The patients were randomly assigned to two groups, with 33 patients using the DBLG1 system, and 35 patients using their normal, open-loop system (i.e., their usual pump and sensor). The study was a crossover trial in which both groups of patients were evaluated using the DBLG1 system for 12 weeks. This study details the results of the first 12-week timeframe.
The results showed that the percentage of time spent in the target blood glucose range of 70-180 mg/dl was 69.3 percent for patients using the DBLG1 system compared to 56.6 percent for patients using an open-loop system. While the average glycemic level was lower for patients with the DBLG1 system compared to the one for patients with standard care, the lowered glucose level did not lead to more hypoglycemic events. The percentage of time spent in hypoglycemia (< 70 mg/dl) was about half the amount with the DBLG1 than with the usual, open-loop system (2 percent and 4.5 percent, respectively).
“The DBLG1 is a powerful and customizable algorithm system for type 1 diabetes treatment that may enable patients to significantly and durably reduce their glucose levels without an increase in hypoglycemic events,” said lead study author Sylvia Franc, MD, research director and vice-president of CERITD—Centre of Study and Research on Intensification of Treatment of Diabetes—in France. “The results of our study confirm in real life, over a 12-week period, the positive results previously observed in an inpatient setting. This system has the potential to substantially improve the glycemic control and the quality of life for patients with type 1 diabetes, decrease long-term chronic diabetes complications, and reduce the burden of the dozens of daily calculations and therapeutic decisions they currently have to make themselves.”
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.
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
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.