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Artificial Pancreas for Type 1 Diabetes

Closed-loop system at home over 12 weeks feasible in type 1 patients.

An artificial beta cell or closed-loop insulin-delivery system expands on the concept of sensor-responsive insulin delivery to reduce the risk of hypoglycemia. The system is different from the conventional insulin pump because it automatically and continuously increases and decrease the delivery of insulin on the basis of real-time sensor glucose levels. However, the feasibility, safety, and efficacy of prolonged use of an artificial beta cell in the home setting has not been established.

Researchers conducted two multicenter, crossover, randomized, controlled studies under free-living home conditions to compare the closed-loop insulin delivery system with sensor-augmented pump therapy. The study included 58 participants with type 1 diabetes; 33 of the participants were adults and 25 were children or adolescents. All participants were fitted with both a glucose sensor and an insulin pump. During the trial, a computer program automatically calculated an appropriate amount of insulin and every 12 minutes would wirelessly communicate with the pump and tell it how much insulin to release. The duration of the study was 12 weeks and primary endpoint was the proportion of time that the glucose level was between 70 mg/dl and 180 mg/dl for adults and between 70 mg/dl and 145 mg/dl for children and adolescents.

Results showed that the 33 adults stayed in target glucose range 68% of the time when the software controlled insulin release compared to 57% of the time when participants controlled their insulin release (P<0.001). Improvements were most significant at night as levels in the normal range was 59% of the time compared to 29% without using the software. Among the 25 children and adolescents, nighttime glucose levels stayed in the target range 60% of the time with the system and 34% of the time without using the software. The children and adolescents only used the system at night after their evening meal and turning it off before breakfast.

In conclusion, extended use of a closed-loop system at home over a period of 12-weeks during free daily living is feasible in adults, children, and adolescents with type 1 diabetes and compared to sensor-augmented pump therapy, the closed system improved glucose control and reduced hypoglycemia.

Practice Pearls:

  • Adults stayed in target glucose range 68% of the time when the software controlled insulin release compared to 57% of the time when participants controlled their insulin release (P<0.001).
  • Children and adolescents nighttime glucose levels stayed in the target range 60% of the time with the system and 34% of the time without using the software.
  • Extended use of a closed-loop system at home over a period of 12-weeks during free daily living is feasible in adults, children, and adolescents with type 1 diabetes and compared to sensor-augmented pump therapy, the closed system improved glucose control and reduced hypoglycemia.

Thabit H, Tauschmann M, Allen JM, et al. “Home Use of an Artificial Beta Cell in Type 1 Diabetes.” N Engl J Med. 2015.