Disclosures: Inreda Diabetic was involved in the study design and data analysis and supplied the artificial pancreas systems. Dexcom read the manuscript before submission and supplied the CGM devices with glucose sensors. Roche supplied infusion sets, pump cartridges and blood glucose meters. Blauw reports she is an employee of Inreda Diabetic. Please see the study for all other authors’ relevant financial disclosures.
February 11, 2021
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Bihormonal artificial pancreas system improves time in range, reduces hypoglycemia

Disclosures: Inreda Diabetic was involved in the study design and data analysis and supplied the artificial pancreas systems. Dexcom read the manuscript before submission and supplied the CGM devices with glucose sensors. Roche supplied infusion sets, pump cartridges and blood glucose meters. Blauw reports she is an employee of Inreda Diabetic. Please see the study for all other authors’ relevant financial disclosures.
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Adults with type 1 diabetes using a fully closed-loop, bihormonal artificial pancreas experienced improved glucose response compared with insulin pump therapy without the need to provide meal or exercise announcements, outpatient data show.

Helga Blauw

“In contrast to other hybrid closed-loop systems, this bihormonal artificial pancreas is a fully closed-loop system, thus no meal or exercise announcements are included,” Helga Blauw, MSc, a technical physician and doctoral student in the department of internal medicine at Amsterdam UMC at the University of Amsterdam, and head of medical at Inreda Diabetic in Goor, the Netherlands, told Healio. “We found that the bihormonal artificial pancreas increased the time in range and reduced the time in hypoglycemia and hyperglycemia compared with standard patient-managed insulin pump therapy. Importantly, the artificial pancreas enabled each individual patient to reach the international consensus treatment goals.”

Adults with type 1 diabetes using a fully closed-loop, bihormonal artificial pancreas spent more time in range and less time in hypoglycemia and hyperglycemia compared with those using insulin pump therapy.

In a single-center, randomized, crossover trial, Blauw and colleagues analyzed data from 23 adults with type 1 diabetes using insulin pump therapy for at least 6 months, without impaired awareness of hypoglycemia (median age, 43 years; mean diabetes duration, 23 years; mean insulin pump use, 11 years). Researchers randomly assigned participants to initiate fully closed loop on an outpatient basis using the bihormonal (insulin and glucagon) artificial pancreas for 2 weeks (Inreda Diabetic) or to continue with normal insulin pump therapy on an outpatient basis (open-loop period). Participants then switched to the other therapy for 2 weeks. During open loop, participants used a continuous glucose monitor or flash glucose monitor if available.

The artificial pancreas consists of two wireless transmitters for obtaining glucose measurements and a wearable device, which integrates the CGM, accelerometer, control algorithm, insulin pump and glucagon pump. The control algorithm included self-learning properties to adjust to the individual’s insulin sensitivity.

“No manual input such as meal or exercise announcements was possible,” the researchers wrote.

Researchers found that time in the recommended glucose range was higher during the fully closed-loop period compared with open loop (median time in range 86.6% vs. 53.9%; P < .0001). The main safety endpoints, time in a state of hypoglycemia (mean, 0.4% vs. 2%; P < .0001) and time in a state of hyperglycemia (mean, 12.8% vs. 38.8%; P < .0001), also improved during the fully closed-loop period compared with open loop. Improved glucose control during closed loop was also found for the other glucose endpoints calculated for the full study or day and night period separately, the researchers wrote.

“The bihormonal artificial pancreas enables fully closed-loop glucose control and relieves patients from making treatment decisions, carbohydrate counting, and adapting their behavior to achieve good glycemic control,” Blauw said. “The available clinical evidence resulted in the first CE-marked bihormonal artificial pancreas. Trials investigating the long-term effectiveness and safety are needed before adoption of this therapy in clinical practice.”

For more information:

Helga Blauw, MSc, can be reached at h.blauw@amsterdamumc.nl.