Two posters presented at APhA in Phoenix examined the efficacy of the Omnipod® 5 Automated Insulin Delivery System.
Automated insulin delivery (AID) is a system in which a continuous glucose monitor (CGM) reports an individual’s glycemic levels to their insulin pump (Pod) and adjusts administered insulin levels as necessary.
Currently, the only AID available through US pharmacies is the Omnipod 5 AID System. Two new posters presented at the APhA annual meeting examined the efficacy of this specific AID on individuals with type 1 diabetes (T1D) and type 2 diabetes (T2D).
One study conducted on the Omnipod 5 was a 15-month trial for patients with T1D.1 The participants were aged from 6 to 70 years old, all with T1D diagnoses for longer than 6 months and hemoglobin A1C levels less than 10%.
Originally, the study was 3 months long, but then participants were invited to extend their use of the AID for an extra 12 months, which 95% did. The participants were split into 2 groups: one including children aged 6 to 13 years and the other including adolescents and adults, aged 14 to 70 years. Outcomes were measured every 3 months and overall, glycemic levels and A1C levels both steadied.
“Mean A1C improvements first observed at the end of the 3-month pivotal study were sustained through 12 additional months of AID use when compared with baseline (p < 0.05)….For both age groups, Time in range improvements were sustained through 15 months of system use compared with standard therapy (p < 0.05),” the researchers wrote.
“The safety and improved glycemic outcomes from the 3-month pivotal study persisted for an additional 12 months, indicating the potential long-term benefit of the Omnipod 5 AID System.”
For the second study, patients with T2D used the same Omnipod 5 device.2 Patients with T2D are not currently approved to use the Omnipod 5, and this study was conducted to test the feasibility of its use on T2D in addition to the already-approved T1D, as well as provide data for a little-studied area of diabetes research.
“Little clinical data is available for use of AID among adults with T2D. Patients living with T2D often do not reach their glycemic targets and will require new approaches to their medication therapy,” the researchers stated.
The original trial lasted for 8 weeks, then a similar extension invitation to the first study was extended; 92% of participants accepted. “After an additional 26 weeks of use,” they found, “Mean A1C was 7.8±0.7%, corresponding to an overall decrease of 1.6±1.2% from baseline to 34 weeks of total use (p < 0.05). There were no episodes of severe hypoglycemia during the study.”
The researchers called these results from the T2D trial “clinically meaningful” for individuals with “sub-optimal glycemic levels.” Based on the data collected, extending AID access to patients with T2D is highly feasible.