Insulet Corporation presented positive results from its first randomized controlled trial (RCT) showing improved glycemic and patient-reported outcomes in type 1 diabetes with the Omnipod 5 Automated Insulin Delivery System (Omnipod 5). The OP5-003 Trialresults were presented at the 17thInternational Conference on Advanced Technologies & Treatments for Diabetes (ATTD) in Florence, Italy. Professor Eric Renard, MD, PhD of Montpellier University Hospital, shared evidence of the efficacy and safety of the automated Omnipod 5 System compared to insulin pump therapy with continuous glucose monitoring (CGM) in adults with type 1 diabetes (T1D) in the United States and France.

Omnipod 5 use led to a 17.5% improvement in time in range (TIR), decreased HbA1c, decreased percentage of time in hypoglycemia, and decreased mean glucose in individuals with baseline HbA1c levels above the recommended target. It is the first Omnipod 5 randomized controlled trial to date, and the first time the system has been evaluated by international participants. Study Overview A key objective of the OP5-003 trial was to evaluate Omnipod 5 in a population that was representative of the real world, primarily participants with an HbA1c above 8% at baseline.

Insulet presented data for 194 adults who had used traditional (non-AID) insulin pump therapy (including 87% using the Omnipod or Omnipod DASH Insulin Management System) for three months or longer and had a HbA1c between 7 and 11% (mean 8.5%). The participants had type 1 diabetes for at least one year and were enrolled at 14 institutions across the United States (61%) and France (39%). The participants were randomized into two groups and studied over the course of 13 weeks.

The control group (n=62) continued to use their usual insulin pump with a Dexcom G6 CGM, while the intervention group (n=132) used Omnipod 5 with Dexcom G6. Key Data Highlights The participants using Omnipod 5 showed a significantly greater TIR (70-180 mg/dL) by 17.5% (43.8% in Control group versus 61.2% in Intervention group), or an additional 4.2 hours per day, and a greater reduction in HbA1c by 0.58% (1.24% with Omnipod 5 vs. 0.68% in the Control group).

The final HbA1c was 7.25% in the Omnipod 5 group versus 7.84% in the Control group. Significantly lower mean glucose and time above 180 mg/dL (%) were also observed in the Omnipod 5 group versus the Control group. Time spent below 70 mg/dL (%) was significantly lower with Omnipod 5 by 0.36%, with mean time below 70 mg/dL (%) decreasing from 1.66% to 1.18% with Omnipod 5, while it increased from 1.66% to 1.75% in the Control group.

Time below 54 mg/dL (%) was shown to be non-inferior (within a 1% margin) between the two groups. This mean value decreased from 0.32% to 0.23% with Omnipod 5 and decreased from 0.42% to 0.37% in the Control group. There were zero events of severe hypoglycemia or DKA with Omnipod 5, and one event of severe hypoglycemia and zero events of DKA in the Control group.

All of the primary and secondary endpoints of the study were met. Exploratory endpoints showed no significant difference in change in total daily dose from baseline or change in body mass index from baseline between the Omnipod 5 and Control groups. Insulet also presented positive patient-reported results related to three key psychosocial measures that were included as secondary endpoints: diabetes distress, hypoglycemia confidence, and diabetes-related quality of life.

As reported by study participants through individual surveys, Omnipod 5 use resulted in both statistically significant and clinically meaningful improvements in each of these three measures compared to the Control group. These results demonstrate that Omnipod 5 provides clinically meaningful improvements in key psychosocial aspects of living with type 1 diabetes. In conclusion, this multi-national, RCT data demonstrates the superiority of the Omnipod 5 AID System compared to standard pump therapy with CGM and indicates that it should be offered as a first-line therapy for adults with type 1 diabetes.

These results will be submitted for publication later this year.