Omnipod 5 System Sustains Glycemic Benefits Through 12 Months

Adults with type 1 diabetes who continued or transitioned to the Omnipod 5 Automated Insulin Delivery (AID) System maintained the glycemic and safety benefits observed in a 13-week randomized controlled trial (RCT) through a 12-month extension phase, according to results published in Endocrinology, Diabetes & Metabolism.¹

The study followed 75 participants from 4 sites in France who elected to continue using the Omnipod 5 System or transition to it after completing the parent RCT (NCT05409131).¹

Sustained Improvements in Time in Range and Hemoglobin A1C

The extension study followed participants from the France cohort of a multicenter RCT that compared the Omnipod 5 System against standard, nonautomated pump therapy with continuous glucose monitoring (CGM) over 13 weeks. Of the 76 eligible participants, 75 consented to the extension phase, and only one participant withdrew before the final visit, having moved out of France.¹

The cohort included 52 participants who had used the Omnipod 5 System during the RCT and 23 who had used standard pump therapy, allowing investigators to assess outcomes both for those continuing AID use and those transitioning to it. Participants were 60% female with a mean age of 40 ± 13 years and a mean diabetes duration of 20.7 ± 10.8 years at baseline.¹

From RCT baseline to the end of the 12-month extension, time in range (TIR) of 70 to 180 mg/dL increased by a mean of 17.9% ± 10.9% (P < .0001), equivalent to 4.3 additional hours per day, rising from 44.6% ± 14.1% at baseline to 62.3% ± 9.3% during the extension. Time above range greater than 180 mg/dL decreased by 17.7% ± 11.3% (P < .0001), and mean sensor glucose fell by 27.8 ± 22.3 mg/dL (P < .0001). There were no significant changes in time below range or total daily insulin use.¹

Hemoglobin A_1C (HbA_1C) dropped from 8.33% at baseline to 7.18% at 12 months, a change of −1.14% (95% CI, −1.31 to −0.97; P < .0001). The proportion of participants with HbA_1C below 7% rose from 0 at baseline to 30 (40.5%) at the 12-month mark, and the proportion below 8% rose from 19 (25.3%) to 67 (90.5%).¹

When stratified by original RCT group assignment, participants originally assigned to the control arm saw HbA_1C fall by −1.16% (95% CI, −1.52 to −0.79; P < .0001) after transitioning to the Omnipod 5 System, and those originally assigned to the intervention arm maintained their RCT-phase improvement, with a −1.13% change (95% CI, −1.33 to −0.94; P < .0001) from baseline sustained at 12 months.¹

Time in range followed a similar pattern. Investigators found that it did not significantly improve during the RCT for the control-arm participants but increased by 19.2% (95% CI, 14.4-23.9; P < .0001) once they moved to the Omnipod 5 System during the extension, and the intervention-arm participants held onto their RCT-phase gains.¹

The proportion of participants meeting international consensus targets for both time in range and time below range rose from 1.4% (95% CI, 0.0-4.0%) at baseline to 20.0% (95% CI, 10.9-29.1%) during the extension. Nearly all participants, 97.3% during the extension compared with 94.6% at baseline, met the target of less than 4% time below range. Body mass index increased by 0.7 kg/m² from baseline to both the 6-month and 12-month extension endpoints, an increase study authors described as unlikely to be clinically meaningful.¹

Safety and Device Performance Held Steady

Safety outcomes were favorable throughout the extension phase. Investigators recorded 9 adverse events, or 12 per 100 person-years, including 1 episode of prolonged hyperglycemia and 8 other nonglycemic adverse events. There were no instances of severe hypoglycemia or diabetic ketoacidosis. Study authors noted that this adverse event rate was lower than diabetic ketoacidosis rates reported elsewhere in Europe (2.5 per 100 person-years) and severe hypoglycemia rates reported in broader real-world European populations (approximately 340 to 450 events per 100 person-years).¹

Seventeen device deficiencies were reported during the extension phase, affecting 13 participants (17.3%), involving the AID controller (10 events), the pod (3 events), the CGM transmitter (3 events), and the CGM sensor (1 event). Participants spent a median of 99.7% of the study period using the Omnipod 5 System in either manual or automated mode and a median of 95.6% of the period specifically in automated mode. The 110 mg/dL target glucose setting was used most often, accounting for 63.2% of time, followed by the 120 mg/dL setting at 23.1% and the 130 to 150 mg/dL settings combined at 13.7%.¹

Quality of Life and Hypoglycemia Confidence Maintained

Patient-reported outcomes were assessed using the Diabetes Quality of Life-brief questionnaire and the Hypoglycemia Confidence Scale (HCS) at baseline and at 6 and 12 months of the extension. Both measures were maintained or improved at both time points compared with RCT baseline, echoing the clinically meaningful differences seen in the intervention group during the RCT phase itself.¹

Study authors noted that all but 1 of the 76 eligible participants opted into the extension, and approximately two-thirds had already been using the Omnipod 5 System as part of the RCT, findings they said support user satisfaction and long-term adoption of the system.¹

The authors acknowledged limitations, including that participants were adults in France already using insulin pump therapy with baseline HbA_1C between 7.0% and 11.0%, meaning results may not generalize to people using multiple daily injections or those with substantially different HbA_1C levels.¹

They also noted a slight decrease in time in range among Omnipod 5 System users between the end of the RCT and the end of the extension phase, which they said may reflect less intensive monitoring during the extension and underscores the importance of ongoing health care professional support to maintain optimal glycemic outcomes with AID therapy.¹

What This Means for Pharmacists

The extension results reinforce findings from other long-term studies of the Omnipod 5 System, including single-arm trials extending to 2 years and a real-world analysis of 69,902 users, and add to a broader body of evidence supporting AID systems as first-line therapy for people with insulin-deficient diabetes.^`

For pharmacists, that growing evidence base intersects with a persistent access gap. A separate report on the ACCESS-AID (Accelerating Care, Capacity and Equity in Automated Insulin Delivery Systems) initiative, describing a New Zealand program, identified workforce constraints, complicated training pathways, and a shortage of practitioners confident in supporting patients through AID transitions as ongoing barriers, alongside insurance navigation hurdles and historically inequitable access for Māori, Pacific peoples, and rural communities.²

That report described a remote hub model built around structured follow-up during the first 12 weeks of AID initiation and a train-the-trainer approach designed to upskill pharmacists and other clinicians. The report stated that the model allows pharmacists to move "from traditional dispensing to a more clinical, technology-focused partnership with patients."²

Device-specific counseling also falls within pharmacists' scope. The Omnipod 5 System is a tubeless AID system that pairs with compatible CGMs, including the Dexcom G6 and G7 and the FreeStyle Libre 2 Plus, and uses an algorithm to adjust insulin delivery automatically every 5 minutes while still requiring manual meal boluses. It is FDA cleared for people 2 years and older with type 1 diabetes and for adults 18 years and older with type 2 diabetes.^1,3

Beyond glycemic targets, the system includes features intended to help patients manage insulin delivery around physical activity, an area where a separate randomized crossover trial of Omnipod 5 users found that enabling the system's Activity feature 30 or 60 minutes before exercise reduced insulin delivery and softened glucose drops during exercise compared with remaining in automated mode, though it did not eliminate hypoglycemia risk.⁴

Pharmacists counseling patients on AID systems may find that the trial’s emphasis on timing, alongside carbohydrate intake, is relevant when discussing exercise management with patients using the Omnipod 5 System.

REFERENCES

1. Renard E, Weinstock RS, Penfornis A, et al. Extended Use of the Omnipod 5 Automated Insulin Delivery System in Adults With Type 1 Diabetes: 12-Month Extension of a Randomized Controlled Trial. Endocrinol Diabetes Metab. 2026;9(5):e70321. doi:10.1002/edm2.70321

2. Gallagher A. Pharmacists help resolve barriers in automated insulin delivery for patients with type 1 diabetes. Drug Topics. March 2, 2026. Accessed September 1, 2026. https://www.drugtopics.com/view/pharmacists-help-resolve-barriers-in-automated-insulin-delivery-for-patients-with-type-1-diabetes

3. Omnipod 5. American Diabetes Association Consumer Guide. Accessed September 1, 2026. https://consumerguide.diabetes.org/products/insulin-pumps/omnipod-5

4. Turner LV, Sherr JL, Zaharieva DP, et al. Use of the Omnipod 5 Automated Insulin Delivery System Activity Feature Reduces Insulin Delivery and Attenuates the Drop in Glycemia Associated With Exercise in a Randomized Controlled Trial. Diabetes Care. 2025;48(9):1598-1606. doi:10.2337/dc25-0141