Abstract
BACKGROUND: Continuous subcutaneous insulin infusion (CSII) treatment with a tubeless patch pump has not been previously evaluated in a large cohort of patients. METHODS: This multisite, retrospective study evaluated glycemic control in patients with type 1 diabetes (n = 873) after 3 months treatment the Omnipod(®) insulin management system (Insulet Corporation, Billerica, MA) compared to prior treatment with multiple daily injections (MDI) (78.1%) or CSII (21.9%). The primary outcome was change in HbA1c from baseline at 3 months post-Omnipod treatment initiation. Secondary outcomes included shifts in HbA1c to target levels, change in total daily dose (TDD) of insulin and in the frequency and severity of hypoglycemic episodes. RESULTS: HbA1c was significantly improved at 3 months post-Omnipod treatment for the total population (mean ± SD): -0.6% ± 1.3 (P < .001). HbA1c was also significantly lower compared to MDI: -0.3% ± 1.3, -0.4% ± 1.4, -0.8% ± 1.3 and -0.6% ± 1.3 (P = .002 to P < .001) and CSII: -0.3% ± 0.8, -1.1% ± 1.6 (P < .01), -0.4% ± 1.1 (P < .001), and -0.5% ± 1.1 (P < .001) for pediatric, adolescent, adult, and total populations, respectively. There was a 37.9% change increase in the proportion of patients ≥18 years and a 39.3% change increase in those <18 years achieving ADA treatment targets (P = .004 to P < .001). There was a 16.4% change decrease in TDD of insulin at 3 months for the total population (P < .001). The frequency of self-reported hypoglycemia decreased significantly (P < .001) by 1.0 ± 2.4 episodes per week. CONCLUSIONS: Treatment with the Omnipod insulin management system was associated with clinically meaningful and statistically significant improvement in glycemic control, reduction in daily insulin requirement and reduction in the frequency and severity of hypoglycemic episodes.