Bionic Pancreas Improves Glycemic Control in Patients With Cystic Fibrosis-related Diabetes
Key Findings
- Cystic fibrosis-related diabetes (CFRD) creates unique challenges for patients and can make achieving good glycemic control difficult
- A study led by Massachusetts General Hospital researchers investigated the safety and efficacy of automated insulin delivery with the iLet bionic pancreas in adults with CFRD
- They report that, compared to usual care, the bionic pancreas improved glucose control over two weeks without an increase in continuous glucose monitoring-measured hypoglycemia
- These results suggest the bionic pancreas may be an effective therapeutic option for adults with CFRD
Up to 50% of adults with cystic fibrosis (CF) are also affected by cystic fibrosis-related diabetes (CFRD), which adds significant morbidity and treatment burden. Patients with CFRD face unique challenges with glycemic control, including pancreatic exocrine insufficiency, high caloric dietary requirements, frequent pulmonary exacerbations, and systemic glucocorticoid treatment.
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In the first randomized trial of a diabetes technology in this patient population, a team of researchers investigated the safety and efficacy of the insulin-only iLet bionic pancreas (BP), an automated insulin delivery technology, in adults with CFRD. They report that BP improved glucose control compared to usual care, without increased continuous glucose monitoring (CGM)-measured hypoglycemia.
Melissa S. Putman, MD, an endocrinologist in the Diabetes Clinical Research Center at Massachusetts General Hospital, Jordan S. Sherwood, MD, a pediatric endocrinologist in the Center, and colleagues share the results in Diabetes Care.
About the Study
In a single-center, open-label, random-order crossover trial, the researchers compared the insulin-only configuration BP to usual diabetes care among 20 adults with CFRD. Participants were all ≥18 years old (50% female), had been diagnosed with cystic fibrosis and diabetes, managed their glucose with insulin (total daily dose of >0.1 units/kg/day), and were required to have a baseline hemoglobin A1c (HbA1c) ≥6% or a mean CGM glucose ≥125 mg/dL.
The study duration was two weeks and visits took place at the Mass General Diabetes Research Center. Participants were randomly assigned to either BP or usual care for 14 days each.
- Primary Outcome: the percent time sensor-measured glucose was in the target range 70–180mg/dL (time in range [TIR]) on days 3–14 of each arm
- Key Secondary Outcomes: mean CGM glucose and the percent time sensor-measured glucose was in the hypoglycemic range <54mg/dL
Study Results
The primary outcome, TIR, was higher in the BP group than the usual care group (75 ± 11% vs. 62 ± 22%, P=0.001) with an estimated 12% treatment difference. Mean CGM glucose was lower in the BP group than in the usual care group (150 ± 19 vs. 171 ± 45 mg/dL, P=0.007).
No significant difference in percent time with sensor-measured glucose <54 mg/dL was reported. However, self-reported symptomatic hypoglycemia episodes were higher during the BP group than in the usual care group. There were no episodes of diabetic ketoacidosis or severe hypoglycemia in either group.
These results support the potential of automated insulin delivery technology as a therapeutic option for adults with CFRD. The researchers note that larger and longer clinical trials are needed to further investigate the safety and efficacy of the BP device in adults with CFRD and other diabetes populations.