(Excerpts from NIH, Oct. 16, 2019): A multicenter randomized clinical trial evaluating a new artificial pancreas system has found that the new system was more effective than existing treatments at controlling blood glucose levels in people with type 1 diabetes. The research is published in the New England Journal of Medicine.

The NIH-funded study of people with type 1 diabetes showed that the system improved participants’ blood glucose control throughout the day and overnight.

The International Diabetes Closed-Loop (iDCL) Study involves five separate artificial pancreas clinical protocols implemented by 10 research centers in the United States and Europe.

The iDCL protocol enrolled 168 participants age 14 or older. They were randomly assigned to use either the artificial pancreas system (Control-IQ) or sensor-augmented pump (SAP) therapy with a continuous glucose monitor (CGM) and insulin pump that did not automatically adjust insulin throughout the day. Participants had contact with study staff every two to four weeks to download and review device data. No remote monitoring of the systems was done, so that the study would reflect real-world use.

• Users of the artificial pancreas system significantly increased the amount of time with their blood glucose levels in the target range of 70 to 180 mg/dL by an average of 2.6 hours per day since beginning the trial, while the time in range in the SAP group remained unchanged over six months.
• Artificial pancreas users also showed improvements in time spent with high and low blood glucose, hemoglobin A1c, and other measurements related to diabetes control compared to the SAP group.
• High adherence to device use in both groups and 100% participant retention were important strengths of the study.
• no severe hypoglycemia events occurred in either group.
• Diabetic ketoacidosis occurred in one participant in the artificial pancreas group due to a problem with equipment that delivers insulin from the pump. 

Dr KK Aggarwal

Padma Shri Awardee

President Confederation of Medical Associations in Asia and Oceania (CMAAO)

Group Editor-in-Chief IJCP Publications

President Heart Care Foundation of India

Past National President IMA