Acton, Massachusetts-based Insulet conducted its first randomized controlled trial showing improved glycemic and patient-reported outcomes in type 1 diabetes with the Omnipod 5 automated insulin delivery (AID) system. The company presented results at the Advanced Technologies & Treatments for Diabetes (ATTD) conference in Florence, Italy.
Dr. Eric Renard of Montpellier University Hospital presented the data. It highlighted Omnipod 5’s efficacy and safety compared to insulin pump therapy with CGM in adults with type 1 diabetes in the U.S. and France. The study marked the first Omnipod 5 randomized controlled trial to date. It’s also the first time the system has been evaluated by international participants.
Omnipod 5 use led to a 17.5% improvement in time in range, decreased HbA1c and decreased time in hypoglycemia. It also led to a decreased mean glucose level in individuals with baseline HbA1c levels above the recommended target.
“Omnipod 5 continues to demonstrate impressive clinical outcomes for people with type 1 diabetes,” said Renard. “We expect this latest set of compelling evidence to have a profound impact on international accessibility and affordability, allowing more people with diabetes to experience the benefits provided by this innovative technology.”
About the Insulet Omnipod 5
Omnipod 5 became the first tubeless, wearable automated insulin delivery system cleared for marketing in the U.S. in January 2022. The Omnipod 5 picked up CE mark approval for ages two and up in September 2022.
Insulet has continued to develop the system since its initial launch. That includes the recent integrations of next-gen CGM, with both Abbott FreeStyle Libre 3 and Dexcom G7 working with the pump.
Omnipod 5 features SmartAdjust technology. Using CGM data, SmartAdjust predicts where glucose will be 60 minutes into the future every five minutes. Omnipod 5 then increases, decreases, or pauses insulin delivery based on the user’s desired and customized glucose target.
The device also features the Omnipod 5 mobile app with an integrated SmartBolus calculator, too. Users can download the app onto a compatible smartphone or use the Omnipod 5 controller.
“Since Omnipod 5’s first commercial launch in the United States, we have been working diligently to expand into new markets and improve access to this life-changing technology,” said Dr. Trang Ly, Insulet SVP and medical director. “By gathering evidence from international participants through a randomized controlled trial, we have demonstrated the true benefit of using our tubeless, disposable automated insulin delivery (AID) system to manage type 1 diabetes over alternative forms of therapy and illustrated the superiority of Omnipod 5 compared to standard pump therapy with CGM for people with type 1 diabetes.”
More on the study results
Insulet’s OP5-003 trial set out to evaluate Omnipod 5 in a population representative of the real world. Primarily, that applied to participants with an HbA1c above 8% at baseline.
The company presented data for 194 adults who used traditional (non-AID) therapy. That included 87% using previous-generation Omnipod or Omnipod Dash systems. Participants used those therapies for three months or longer and had HbA1c between 7% and 11% (mean 8.5%). They had type 1 diabetes for at least one year and were enrolled across 14 institutions in the U.S. (61%) and France (39%).
Participants split into two randomized groups over the course of 13 weeks. The control group (62 subjects) used their usual pump with Dexcom G6 CGM. The intervention group (132 subjects) used Omnipod 5 with the G6.
Insulet reported that Omnipod 5 users showed a significant time in range improvement totaling an additional 4.2 hours per day. They saw a greater reduction in HbA1c (0.58%) difference.
Results demonstrated significantly lower mean glucose and time above 180 mg/dL in the Omnipod 5 group. That group also spent significantly less time below 70 mg/dL. Mean time decreased from 1.66% to 1.18% with Omnipod 5, compared to an increase from 1.66% to 1.75% in the control group.
Time below 54 mg/dL proved non-inferior between groups. Insulet reported zero events of severe hypoglycemia or diabetic ketoacidosis with Omnipod 5. The study had one event of severe hypoglycemia and zero diabetic ketoacidosis events in the control.
According to Insulet, the study met all primary and secondary endpoints. Exploratory endpoints showed no significant difference in the change in total daily dose from baseline or change in body mass index from baseline between Omnipod 5 and control.
Psychosocial data
Insulet also presented positive patient-reported results related to three key psychosocial measures. it included those measures — diabetes distress, hypoglycemia confidence and diabetes-related quality of life — as secondary endpoints.
Omnipod 5 use, as reported through individual surveys, resulted in both statistically significant and clinically meaningful improvements in each of these three measures compared to control.
Insulet concluded by saying the multi-national data demonstrates Omnipod 5’s superiority to standard pump therapy with CGM. The company believes it should be offered as a first-line therapy for adults with type 1 diabetes.