Abstract

The Omnipod® 5 Automated Insulin Delivery (AID) System was shown to be safe and effective following 3 months of use in people with type 1 diabetes (T1D); however, data on the durability of these results are limited. This study evaluated the long-term safety and effectiveness of Omnipod 5 use in people with T1D during up to 2 years of use.After a 3-month single-arm, multicenter, pivotal trial in children (6-13.9y) and adolescents/adults (14-70y), participants could continue system use in an extension phase. HbA1c was measured every 3 months for up to 15 months; CGM metrics were collected for up to 2 years.Participants (N=224) completed median [IQR] 22.3 [21.7, 22.7] months of AID. HbA1c was reduced in the pivotal trial from 7.7±0.9% in children and 7.2±0.9% in adolescents/adults to 7.0±0.6% and 6.8±0.7%, respectively, (p<0.0001), and was maintained at 7.2±0.7% and 6.9±0.6% after 15 months (p<0.0001 from baseline). Time in target range (70-180mg/dL) increased from 52.4±15.6% in children and 63.6±16.5% in adolescents/adults at baseline to 67.9±8.0% and 73.8±10.8%, respectively, during the pivotal trial (p<0.0001), and was maintained at 65.9±8.9% and 72.9±11.3% during the extension (p<0.0001 from baseline). One episode of diabetic ketoacidosis and 7 episodes of severe hypoglycemia occurred during the extension. Children and adolescents/adults spent median 96.1% and 96.3% of time in Automated Mode, respectively.Our study supports that long-term use of the Omnipod 5 AID System can safely maintain improvements in glycemic outcomes for up to 2 years of use in people with T1D.

View details for DOI 10.1089/dia.2023.0364

View details for PubMedID 37850941