The company recently submitted its study results to the FDA for an expansion of Omnipod 5’s indications for use. It hopes to garner clearance for the type 2 diabetes population and launch in the U.S. in early 2025.
Acton, Massachusetts–based Insulet shared the data at the American Diabetes Association Scientific Sessions in Orlando, Florida. The study evaluated the impact of automated insulin delivery in a diverse group of people with type 2 diabetes who require insulin.
SECURE-T2D demonstrated glycemic improvements with the use of Omnipod 5 compared to prior treatment of insulin injections or pump therapy in adults with type 2 diabetes. Outcomes included significant reductions in HbA1c, time in hyperglycemia and total daily insulin dose. Insulet also reported a large improvement in time in range without increasing time in hypoglycemia. The company also said the study demonstrated a clinically meaningful improvement in diabetes distress.
“These data demonstrate that simple, easy-to-use AID technology, such as Omnipod 5, can be adopted by a broad population of people with type 2 diabetes and improve their lives,” said Dr. Trang Ly, Insulet SVP and medical director. “A major strength of this study is the diversity of the enrolled population in terms of varying education level, income, ethnicity, and race. These results could have a particularly striking impact among Black and Hispanic people, who experience a higher prevalence of type 2 diabetes and increased mortality rates.”
No FDA-cleared automated insulin delivery system currently exists in the U.S. for the type 2 diabetes population. Insulet’s Omnipod 5 currently caters to the type 1 population, although the company has had studies underway for years evaluating the system for type 2. The company also has an FDA-cleared basal-only pod — Omnipod GO — for the type 2 population.
More on the data presented by Insulet
SECURE-T2D had a primary objective of evaluating change in HbA1c with Omnipod 5 in adults aged 18-75 years with type 2 diabetes with a current insulin regiment for at least three months. Other criteria included a baseline HbA1c between 7% and 12% for those using basal insulin only. The study set the bar at 12% or less for those using basal and bolus or pre-mixed insulin.
Secondary objectives included demonstrating improvements in time in range and time in hyperglycemia, plus non-inferiority for hypoglycemia. Investigators also evaluated diabetes distress, a patient-reported outcome.
Notably, the study featured a significantly racially diverse population. Of 305 participants from 21 U.S. sites, the study featured 24% Black and 22% Hispanic participants. More than half (55%) were on a stable dose of GLP-1 receptor agonists and 73% used multiple daily injections of insulin. Insulet said 21% used basal-only insulin at baseline and only 5.6% used an insulin pump at baseline.
After an initial 14 days of standard therapy, study participants used Omnipod 5 for 13 weeks. They could eat and exercise iwth no restrictions and had the option to bolus for blood glucose corrections only, for actual carbohydrate intake or for a set carbohydrate regimen.
Insulet reported an HbA1c reduction with Omnipod 5, dropping from 8.2% to 7.4%. Patients saw significant HbA1c improvements regardless of prior therapy.
Time in range also significantly improved with Omnipod 5, rising by 20%, or 4.8 hours per day. Insulin use also reduced from an average of 0.8 U/kg/day during standard therapy to 0.57 U/kg/day during automated insulin delivery. That equals an average decrease of 23 U/day.
Patients reported a significant and clinically meaningful mprovement in diabetes distress. Insulet also reports no instances of diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic syndrome (HHS). The study had one occurrence of severe hypoglycemia during treatment, deemed unrelated to trial device malfunction. Insulet noted 13 additional serious adverse events, with none related to glycemia or related to the trial device.
