Adults with type 1 diabetes who initiated treatment with the iLet Bionic Pancreas through primary care physicians achieved comparable glycemic benefits to those starting the device with endocrinologists, according to new research published in Clinical Diabetes. This finding suggests the automated insulin delivery system could significantly expand access to advanced diabetes technology.
In the open-label, random-order crossover trial, 97% of participants achieved an average glucose (AG) of less than 183 mg/dL after two weeks of using the bionic pancreas, with 64% reaching an AG below 154 mg/dL. Notably, researchers found no significant differences in glucose control between primary care and specialty settings, or between telehealth and in-person device initiation.
"The iLet Bionic Pancreas system was previously studied only in diabetes subspecialty centers, although half of adults with type 1 diabetes receive care from primary care providers," explained corresponding author Sean M. Oser, MD, MPH, associate professor of family medicine at University of Colorado Anschutz Medical Campus.
Study Design and Participant Demographics
Researchers enrolled 40 adults with type 1 diabetes aged 18 to 85 years with HbA1c levels below 11% and adequate renal function. The cohort had a mean age of 44.8 years and was 43% female. Participants were evenly distributed between primary care (20) and endocrinology (20) settings, with half of each group receiving care via telehealth.
The four-week study randomly assigned participants to either two weeks with the bionic pancreas or two weeks of usual care before crossing over to the alternate treatment. This design allowed researchers to directly compare outcomes between care settings and delivery methods.
Key Findings and Glycemic Outcomes
The primary outcome—achieving an average glucose below 183 mg/dL—was met by nearly all participants (97%), regardless of care setting. The secondary target of AG below 154 mg/dL was achieved by 64% of participants.
Interestingly, patients in the primary care group experienced greater improvements in several important metrics compared to those under endocrinologist care:
- Time below range <70 mg/dL (P = .002)
- Time below range <54 mg/dL (P = .04)
- Coefficient of variation (P = .015)
"Every group had remarkable glucose level results during their time using the iLet bionic pancreas system, with no clinically meaningful differences whether their device onboarding and management was done in person or by telehealth, or whether it was done by the diabetes specialty team that has more experience with the system than anyone else in the world, or by a primary care team that had never managed the device before this study," Oser told Healio.
Simplified Technology May Expand Access
The iLet Bionic Pancreas differs from other automated insulin delivery systems by its simplified setup process. Users only need to enter their weight for the device to determine insulin needs and dosing, potentially reducing barriers to adoption for both patients and healthcare providers.
"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 noted. "In theory, primary care could support this system and start people on it more sustainably than other insulin pump systems that have very low primary care penetration."
Safety and Patient Experience
No diabetic ketoacidosis events, deaths, or severe adverse device effects occurred during the study. Minor technical issues were reported, with four participants in the endocrinology group experiencing infusion set failures and four in the primary care group reporting cartridge issues.
The researchers found no significant changes in patient-reported outcomes including diabetes distress, hypoglycemia confidence, diabetes technology attitudes, and fear of hypoglycemia between usual care and bionic pancreas use.
Future Research Directions
Building on these promising results, Oser's team is planning a larger randomized controlled trial that will include more primary care clinics and expand to include adults with insulin-treated type 2 diabetes.
"The longer duration, larger number of providers and patients, the inclusion of type 2 diabetes and the randomized nature will provide more definitive evidence of how the system performs in real-world primary care settings," Oser explained.
Implications for Diabetes Care
These findings suggest that the iLet Bionic Pancreas could help address significant gaps in diabetes technology access, particularly for patients who lack access to endocrinologists due to geographic or healthcare system limitations.
"These findings suggest that this device, with its uniquely simplified initialization and use, may expand access to AID technology to more patients who otherwise may be limited by geography and/or access limitations to subspecialty care," the researchers concluded.
As automated insulin delivery systems continue to evolve, the ability to effectively implement these technologies in primary care settings could democratize access to advanced diabetes management tools, potentially improving outcomes for a broader population of people living with type 1 diabetes.
