Multi-center study compares Diabeloop DBLG1 closed-loop device to standard open-loop system in a home setting.
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 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,” was presented at the American Diabetes Association’s® (ADA’s) 78th Scientific Sessions®.
The Diabeloop DBLG1 system is an advanced, closed-loop insulin delivery system with a complex, customizable algorithm that predicts future 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 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 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 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.
- 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 Diabeloop closed-loop system was efficient regarding metabolic outcomes.
247-OR 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. ADA 78th Scientific Sessions 2018