A recent study suggests that the iLet bionic pancreas could be effectively implemented in primary care settings and through telehealth, offering a viable solution for adults with type 1 diabetes. This innovative automated insulin delivery system provided significant glycemic benefits, with nearly all participants achieving a glucose average of less than 183 mg/dL within two weeks, regardless of whether they were managed by a primary care provider or an endocrinologist.
The study, published in Clinical Diabetes, enrolled 40 adults with type 1 diabetes, ranging in age from 18 to 85. The participants, who had an HbA1c of less than 11% and a glomerular filtration rate above 30 mL/min/1.73 m², were randomly assigned to either use the bionic pancreas or receive usual care for two weeks. Half of the participants attended primary care clinics, while the other half were treated by endocrinologists. Each group was further divided into those who received in-person care versus those who were managed via telehealth.
The results were striking: 97% of participants achieved a continuous glucose monitoring (CGM) average of less than 183 mg/dL, and 64% reached an average below 154 mg/dL. Crucially, no significant differences were found between those receiving care from primary care providers and those under the care of endocrinologists, nor between in-person and telehealth management.
Dr. Sean M. Oser, an associate professor of family medicine at the University of Colorado Anschutz Medical Campus, highlighted the study’s findings as an indication that the bionic pancreas could be deployed in a variety of healthcare settings, improving access to automated insulin delivery. He emphasized that the device’s simpler setup — where users only need to input their weight for insulin dosing — could make it easier for primary care providers to adopt and manage the technology, thus making it more accessible for a larger number of patients.
“If these kinds of glucose levels can be achieved with less intensive engagement required by the treating practitioner and less work by the patient, imagine how many more patients could be transitioned to a system like this,” Oser told Healio. He noted that primary care settings could sustainably manage patients on the bionic pancreas, particularly in comparison to traditional insulin pump systems that have had limited success in primary care environments.
The study also revealed that adults in the primary care group showed greater improvements in time spent with glucose levels below the target range of 70 mg/dL, as well as a reduced coefficient of variation in glucose levels, compared to those treated by endocrinologists. However, no changes in daily insulin doses, diabetes distress, or attitudes toward diabetes technology were observed between the groups.
Notably, there were no severe adverse events, such as diabetic ketoacidosis or device-related deaths, during the study. While four patients in the endocrinologist group experienced infusion set failures, none in the primary care group did. However, four participants in the primary care group did encounter issues with the bionic pancreas cartridge, while no such issues were reported in the endocrinologist group.
Dr. Oser’s team is now preparing for a larger randomized controlled trial, which will include a wider range of primary care settings and patients, as well as adults with insulin-treated type 2 diabetes. This next phase of research aims to provide more definitive evidence on the bionic pancreas’ effectiveness in real-world primary care settings, particularly in comparison to traditional insulin delivery methods.
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