Artificial pancreas closed-loop insulin delivery system provides better glycemic control and reduces risk of hypoglycemia underscores study presented at this year's European Association for the Study of Diabetes Annual Meeting (EASD) in Berlin, and published in the Lancet. In summary, the trial shows that the use of a day-night closed-loop hybrid insulin delivery system is better than enhanced sensor pump therapy for glycemic control in the treatment of diabetes mellitus. poorly controlled type 1.
Reminders:
- sensor pump therapy combines the technology of an insulin pump with a continuous glucose monitoring sensor that transmits glucose readings to the person wearing the device. With this device, the wearer of the device is informed and responsible for the dosage of insulin.
- The “artificial pancreas” takes technology to the next level: it combines continuous glucose monitoring with the insulin pump and an algorithm that automates the administration of insulin.
- Hybrid closed-loop systems are characterized by the coexistence of automated insulin delivery, via an algorithm, and user-triggered insulin delivery, for example by delivering mealtime boluses. In 2017, the first hybrid closed-loop system entered clinical use based on a non-randomized single-arm pivotal safety trial.
The study is conducted by Dr. Roman Hovorka, from the University of Cambridge among 86 participants (44 men and 42 women), type 1 diabetics, and aged 6 to 65 years. These participants were assigned to receive either hybrid closed-loop therapy (N=46) or sensor pump therapy (N=40) for 12 weeks. Training in the insulin pump and continuous glucose monitoring took place over a prior period of 4 weeks. The test shows that:
- The proportion of time that blood glucose remains within the target range (between 3.9 and 10.0 mmol/l) is significantly higher in the closed-loop group (65%) vs control group (54%);
- in the closed-loop hybrid treatment group, glycated hemoglobin (HbA1c), a measure of blood sugar control was reduced from 8.3% to 8.0% after training and before the intervention to 7.4% at the end of the study. In the control group, these values were 8.2%, 7.8% and 7.7%; reductions in HbA1c levels are found to be significantly greater in the closed-loop group vs control group (mean difference in change of 0.36%).
- time spent with blood glucose below 3.9 mmol/l (very low blood sugar or hypoglycaemia) is 12 minutes lower on average in the closed-loop group;
- time spent above 10.0 mmol/L (hyperglycemia) was lower by an average of 2 hours and 24 minutes in the closed-loop group;
- the proportion of time spent in these hazardous conditions is found to be reduced overall by an average of 3.5% in the closed-loop group, falling to an average of 2.6% after the study;
- the total daily insulin dose and the change in body weight remained similar in the 2 groups;
- no cases of severe hypoglycemia were observed, however, diabetic ketoacidosis occurred in one participant in the closed-loop group due to infusion failure.
- Thus, the use of a hybrid, day-and-night, closed-loop insulin delivery device improves glycemic control while reducing the risk of hypoglycemia in adults, adolescents and children with type 1 diabetes. 1 compared to conventional pump or sensor pump therapy.
Results that support the adoption of closed-loop artificial pancreas technology in clinical practice and for all age groups.
.jpg)
