The Effect of Omnipod 5 Automated Insulin Delivery on Glycemic Control in Adolescents and Adults with Cystic Fibrosis-Related Diabetes

Abstract

Background: Studies investigating the safety and efficacy of automated insulin delivery (AID) systems in people with cystic fibrosis-related diabetes are limited. There are no published studies investigating the tubeless Omnipod 5 (OP5) AID system. Methods: This dual-center retrospective cohort study compared 14 days of baseline continuous glucose monitoring (CGM) data with days 1-90 and 91-180 post-OP5 initiation. Multivariable mixed-effects linear regression models were used to assess changes in glycemic metrics. Results: Among the 26 individuals with sufficient data initiating OP5, 65% were female, with a median age of 27.3 years and median diabetes duration of 10.9 years. Six (23%) had a history of solid organ transplant, and 2 (8%) were receiving enteral tube feeds. Participants transitioned to OP5 from multiple daily injections (54%), prior Omnipod generation (31%), or another AID system (15%). CGM time in range (70-180 mg/dL) increased from 54% (95% confidence interval [CI]: 45.0, 63.0) to 64% (95% CI: 57, 71.8, P < 0.001) during the first 90 days and to 62.7% (95% CI: 54.9, 70.5, P < 0.001) during 91-180 days. Time above range (TAR) 181-250 mg/dL and TAR >250 mg/dL improved at 1-90 days and 91-180 days compared with baseline (P = 0.001 and P = 0.002, respectively). There were no significant changes in time below range (54-69 mg/dL, <54 mg/dL) or coefficient of variation. Two individuals discontinued OP5 within 14 days due to persistent hypoglycemia. One adult experienced a hypoglycemic seizure after 3 months of use. Conclusions: Use of the OP5 system in youth and adults with CFRD led to significant improvements in multiples measures of hyperglycemia without a change in CGM-measured hypoglycemia over a 6-month period, although patient experience with hypoglycemia may limit sustained use. Given the unique comorbidities and pathophysiology of CFRD, these results emphasize the need for future studies to investigate the safety and efficacy of AID devices in this patient population.

Keywords: Omnipod 5; automated insulin delivery; continuous glucose monitoring; cystic fibrosis; cystic fibrosis-related diabetes.