Patients with Type 1 diabetes must monitor their blood glucose levels regularly and administer insulin injections, but another treatment option may soon become available that has been shown to be more effective at delivering insulin when it is needed and avoiding dangerous falls in blood glucose levels, especially at night.
Clinical trials of a new closed loop artificial pancreas have shown the system to be more effective than the technologies currently used by type 1 diabetes sufferers at regulating blood sugar levels and keeping them within the ideal range.
The system being tested is an all-in-one diabetes management system that continuously monitors blood glucose levels and delivers insulin via an insulin pump when it is required. Current methods used by type 1 diabetes sufferers are either finger prick tests or a continuous glucose monitoring solution with either manual injections or a separate user-controlled insulin pump.
The randomized, multicenter clinical trial tested five different artificial pancreas clinical protocols at 10 research centers over a 6-month period. Patients were able to go about their daily routines to determine how the artificial pancreas functioned in a real-world setting and to assess its safety and effectiveness.
The International Diabetes Closed-Loop (iDCL) Study was conducted on 168 type 1 diabetes sufferers aged 14 and over. The participants were split into two different groups. One used the artificial pancreas system (Control-IQ) which contained algorithms that used patients’ glucose monitoring data to deliver the required dose of insulin. The other group used a sensor-augmented pump and continuous glucose monitor that did not automatically adjust insulin throughout the day.
All patients met with the researchers every 2-4 weeks who downloaded their data, but they were not otherwise monitored to more closely reflect a real-world usage scenario.
Patients with the artificial pancreas maintained blood glucose levels in the ideal range for an average of 2.6 hours per day longer than those using the sensor-augmented pump. The period of time spent with high or low blood glucose, hemoglobin A1c, and other diabetes control measurements was also reduced in the group using the artificial pancreas system.
None of the patients in either group experienced a severe hypoglycemic event during the period of study and only one case of diabetic ketoacidosis occurred, which was due to the failure of the artificial pancreas to deliver insulin on one occasion.
“This study demonstrated that in participants with type 1 diabetes, use of the Control IQ system led to improved glucose control during both the day and night for a wide range of ages including adolescents to older adults,” said R. Paul Wadwa, MD, associate professor of pediatrics at the Barbara Davis Center for Childhood Diabetes at Colorado University Anschutz and co-author of the study. “We are hopeful that the system studied in this trial will potentially offer a valued treatment option to benefit people with type 1 diabetes.”
The results of the clinical trial can be are detailed in the paper – Six-Month Randomized, Multicenter Trial of Closed-Loop Control in Type 1 Diabetes – which was recently published in the New England Journal of Medicine. DOI: 10.1056/NEJMoa1907863