Insulet has reported results from two clinical studies, STRIVE and EVOLUTION 3, assessing its upcoming Omnipod 6 automated insulin delivery (AID) system and a fully closed-loop (FCL) solution for adults with type 2 diabetes (T2D).
The STRIVE pivotal trial evaluated the safety and effectiveness of the Omnipod 6 algorithm in a diverse US cohort of 132 participants, ranging in age from two to 70 years.
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Of these, 98 had type 1 diabetes (T1D), and 34 had T2D. Study participants were randomised to use either Omnipod 6 at a 100mg/dL glucose target or Omnipod 5 at 110mg/dL, each for four weeks.
After crossover, all subjects continued in a bolus-optional phase, targeting three or fewer mealtime insulin boluses per day.
Findings from the STRIVE study indicated improved glycaemic control with Omnipod 6 compared to Omnipod 5.
In participants aged 14 years and older with T1D, time in the tighter target range (70mg/dL-140mg/dL) was 54% with Omnipod 6, compared with 47% for Omnipod 5. Time in the standard 70mg/dL-180mg/dL range was 77% versus 73%, respectively.
For those with T2D, time in range was 48% for Omnipod 6 and 43% for Omnipod 5, while the wider range showed 76% and 73%, respectively. The safety profile remained consistent, with no severe hypoglycaemia or diabetic ketoacidosis reported.
Insulet also released results from the EVOLUTION 3 feasibility study, which evaluated its FCL system in 36 adults aged 18–75 with T2D and a baseline HbA1c of 8.1%.
Use of the FCL system increased time in range to 64% (a 12% improvement) and reduced daily insulin requirements from 86 units to 58 units, with no associated weight gain. Overall, 86% of participants reported satisfaction with the system.
Insulet senior vice president and chief medical officer Dr Trang Ly said: “Omnipod 6 represents one of our biggest steps forward yet, with greater personalisation and responsiveness to hyperglycaemia, by delivering up to 50% more automated insulin, as shown in the STRIVE results.”
“Our fully closed-loop system for T2D is intentionally designed to unlock barriers to AID by managing mealtime insulin and simplifying workflows to expand clinic adoption.”
Insulet recently began enrolling for the EVOLVE pivotal trial in support of a planned 2027 filing with the US Food and Drug Administration and an anticipated 2028 commercial launch.
Early clinical development is also underway for fully closed-loop systems in T1D.
