Bionic pancreas for type 1 diabetes feasible to implement in primary care, telehealth
Key takeaways:
- The iLet bionic pancreas system conferred an average glucose of less than 183 mg/dL in 97% of adults with type 1 diabetes.
- Glycemic benefits were similar for adults attending primary care vs. an endocrinologist.
Adults with type 1 diabetes who initiated treatment with a bionic pancreas at a primary care site experienced similar glycemic benefits as those starting the device through an endocrinologist, researchers reported.
In a small study published in Clinical Diabetes, 97% of all adults achieved a continuous glucose monitoring average glucose of less than 183 mg/dL at 2 weeks with use of the iLet bionic pancreas automated insulin delivery system (Beta Bionics) and 64% had a average glucose of less than 154 mg/dL, with no differences in glucose levels between those attending primary care vs. an endocrinologist, and no differences between telehealth and in-person device initiation.
The researchers wrote that the bionic pancreas has a simpler setup than other automated insulin delivery systems, with users only needing to enter their weight for the device to determine insulin needs and dosing.
Sean M. Oser, MD, MPH, an associate professor of family medicine and associate director of the primary care diabetes lab at University of Colorado Anschutz Medical Campus, said the study revealed how the bionic pancreas could be implemented in multiple health care settings, which could increase access to automated insulin delivery.
“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. “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, and specialty teams could support starting and managing more patients on technology like this, since the time needed for system training and startup as well as for ongoing management is less.”
Researchers enrolled 40 adults aged 18 to 85 years with type 1 diabetes, an HbA1c of less than 11% and an estimated glomerular filtration rate of 30 mL/min/1.73 m2 or higher (mean age, 44.8 years; 43% women) to participate in a 4-week open-label crossover trial. There were 20 adults attending a primary care clinic and 20 adults receiving treatment through an endocrinologist enrolled in the study. Within each group, 10 adults attended in-person visits, and 10 participants received care through telehealth. Participants were randomly assigned to 2 weeks of the bionic pancreas automated insulin delivery system or 2 weeks of usual care. Adults crossed over to the opposite group at 2 weeks. The primary outcome of the trial was the proportion of adults achieving a CGM average glucose of less than 183 mg/dL, with the key secondary outcome being the percentage of participants achieving an average glucose of less than 154 mg/dL.
Glycemic benefits with bionic pancreas
At 2 weeks, 97% of adults had an average glucose of less than 183 mg/dL and 64% had an average glucose of less than 154 mg/dL. No significant differences in the percentage of adults achieving the average glucose goals were observed between primary care and endocrinologist care, or between in-person care and telehealth.
“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 said. “It certainly seems likely, therefore, that the system and its automation and its relative simplicity for both patients and practitioners alike are what drives the glucose results, not the practitioner’s specialty or level of experience.”
Adults in the primary care group had greater improvements in time below range of less than 70 mg/dL (P = .002), time below range of less than 54 mg/dL (P = .04) and coefficient of variation (P = .015) with bionic pancreas use than adults receiving care from an endocrinologist. Total daily insulin dose did not change with the bionic pancreas for any subgroup. No changes were observed in diabetes distress, hypoglycemia confidence, diabetes technology attitudes and fear of hypoglycemia between usual care and the bionic pancreas.
No diabetic ketoacidosis events, deaths or severe adverse device effects were reported. Four adults receiving care from an endocrinologist had an infusion set failure vs. none of the primary care group, whereas four adults attending primary care had a cartridge issue with the bionic pancreas vs. no participants in the endocrinologist group.
Randomized trial planned
Oser said his team is preparing to conduct a larger randomized controlled trial, which will include a larger group of primary care clinics and patients, as well as 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, compared directly to patients’ usual method of insulin delivery and glucose management, rather than compared to endocrinologists,” Oser said.
For more information:
Sean M. Oser, MD, MPH, can be reached at sean.oser@cuanschutz.edu.
Perspective
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This was a unique study comparing primary care to endocrinology care management of an automated insulin delivery system. These systems are usually started in endocrinology due to the perceived complexities of starting the pump and managing insulin adjustments. The iLet bionic pancreas is unique in that the startup is less complex since there are no programmed basal and bolus settings. The use of the pump is simpler than most others since there is no carbohydrate counting, but rather only announcing meals.
Automated insulin delivery systems are recommended first line for people with type 1 diabetes by the ADA Standards of Care; however, not every person has access to endocrinology. Being able to offer this in primary care would tremendously help increase access. This trial demonstrated that outcomes in primary care were comparable to endocrine care with this pump.
There are limitations in that it only included 40 participants, and they only used the iLet bionic pancreas for 2 weeks. Also, the care and training in a clinical trial can be different compared to real-world care. I still think this is promising to increase access to more people. I look forward to seeing future research with implementation in type 2 diabetes and it would be great to see the outcomes of real-world data.
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