Canadian Real-World Outcomes of Omnipod Initiation in People with Type 1 Diabetes (COPPER study): Evidence from the LMC Diabetes Registry

Aims To investigate real-world clinical outcomes in adults with type 1 diabetes who initiated the Omnipod Insulin Management System (Insulet Corp., Acton, MA, USA) compared to a matched cohort who maintained multiple daily injection therapy. Methods This retrospective observational study used data from the Canadian LMC Diabetes Registry. Adults with type 1 diabetes who switched from multiple daily injections to the Omnipod system as usual standard of care between January 2011 and April 2019 were matched to a cohort of adults with type 1 diabetes who maintained multiple daily injection therapy, using propensity-score matching. The primary outcome was change in HbA(1c) at 3- to 6-month follow-up. Results Propensity-score matching resulted in a final analytical cohort of 286 individuals (143/cohort). HbA(1c) in the Omnipod cohort was reduced by a mean +/- sd of -3 +/- 10 mmol/mol (-0.2 +/- 1.0%; P = 0.005) with no change in the MDI cohort [0 +/- 10 mmol/mol (0.0 +/- 1.0%); P = 0.74]. HbA(1c) change was seen only in persons with baseline HbA(1c) >= 75 mmol/mol (>= 9.0%) [Omnipod cohort: -15 +/- 12 mmol/mol (-1.4 +/- 1.1%); P 0.001] with a between-treatment difference [mean (95% CI)] of -12 (-18, -6) mmol/mol [-1.1 (-1.6, -0.5) %, P < 0.001]. The median total daily dose of insulin was lower following Omnipod initiation (baseline 0.63 U/kg vs follow-up 0.53 U/kg; P 0.001), with no change in the MDI cohort (baseline 0.68 U/kg vs follow-up 0.67 U/kg; P = 0.23). Conclusions Adults with type 1 diabetes who initiated use of the Omnipod system in a real-world clinical setting had lower HbA(1c) and total daily dose of insulin at 3- to 6-month follow-up compared to a matched cohort of adults who maintained multiple daily injection therapy. A treatment difference in HbA(1c) change was seen only in people with baseline HbA(1c) >= 75 mmol/mol (9.0%). (Clinical trials registration: NCT04226378).