The trial builds on a 13-week multicenter randomized controlled trial conducted in the United States and France, in which 194 adults aged 18 to 70 were assigned either to the Omnipod 5 System or to continue their existing non-automated insulin pump therapy with continuous glucose monitoring. In that original phase, the automated system clearly outperformed conventional pumps: participants spent 61.2 percent of their time in the target glucose range of 70 to 180 milligrams per deciliter, compared with 43.8 percent for controls, a difference of more than four hours per day spent in the healthy range. The extension study followed 75 of the 76 French participants who agreed to continue, including 23 who had originally served as controls and now transitioned to the automated system.

The technology itself represents a notable engineering achievement. Omnipod 5 is the first tubeless automated insulin delivery system, combining a disposable, wearable insulin pump called a Pod with a built-in control algorithm, a wirelessly connected smartphone application, and the Dexcom G6 continuous glucose monitor. Operating in Automated Mode, the system delivers tiny micro-boluses of insulin every five minutes, continuously nudging glucose toward a user-selected target that can be customized in 10 milligram per deciliter increments between 110 and 150 milligrams per deciliter. This closed-loop design replaces much of the guesswork of manual pump therapy with an algorithm that responds to every fluctuation the sensor detects.

The results after one year were striking. Participants spent a median of 99.7 percent of the study period wearing and using the system, and a median of 95.6 percent of the time in Automated Mode rather than reverting to manual control, a strong signal of satisfaction and trust in the algorithm. Most of the time, 63.2 percent, users chose the most ambitious 110 milligram per deciliter target. Compared with their pre-trial baseline, participants increased their time in range by an average of 17.9 percentage points, equivalent to 4.3 additional hours per day in the healthy glucose zone, while their mean glucose fell by nearly 28 milligrams per deciliter. Time spent above range dropped by 17.7 percentage points, and critically, time spent in hypoglycemia did not increase at all.

Perhaps the most dramatic shift appeared in a standard laboratory measure of long-term glucose control. The average hemoglobin A1c of the cohort fell from 8.33 percent at baseline to 7.18 percent after 12 months, an improvement of 1.14 percentage points that remained statistically robust at every quarterly checkpoint. At the start of the study, not a single participant met the internationally recommended target of an A1c below 7 percent; by the end, 30 participants, or 40.5 percent of the cohort, had crossed that threshold. The proportion meeting the stricter goal of below 8 percent rose from roughly one in four to more than 90 percent of all participants. Notably, participants with the highest starting A1c levels experienced the greatest improvements, suggesting the system holds particular value for those struggling most with conventional therapy.

Safety data were equally encouraging. Over the full year, researchers recorded just nine adverse events, a rate of 12 per 100 person-years, including a single episode of prolonged hyperglycemia. There were no cases of severe hypoglycemia, diabetic ketoacidosis, or other serious glycemic emergencies, rates well below population-level figures reported across Europe. Seventeen device deficiencies were reported among 13 participants, most involving the handheld controller, but none resulted in serious harm. Body mass index rose slightly, by 0.7 kilograms per square meter, an increase the authors judged unlikely to be clinically meaningful.

The durability of these gains matters because time in range is increasingly recognized as a predictor of long-term outcomes. A growing body of evidence links greater time within the target glucose range with reduced risks of the microvascular complications of diabetes, including retinopathy, nephropathy, and neuropathy. The proportion of participants in this study meeting international consensus targets of at least 70 percent time in range together with less than 4 percent time below range rose more than fourteen-fold, from 1.4 percent at baseline to 20 percent at one year. Although the study was not designed to measure complication rates directly, the authors argue that sustained glycemic improvements of this magnitude may translate into clinically meaningful long-term protection.

Patient-reported measures reinforced the clinical picture. Scores on the Diabetes Quality of Life questionnaire and the Hypoglycemia Confidence Scale improved during the randomized phase and were maintained at both six and twelve months of the extension, indicating that users did not merely tolerate the technology over time but continued to feel confident managing hypoglycemia and less burdened by intensive treatment. The near-universal uptake is itself telling: all but one of the 76 eligible participants opted to continue into the extension, and only one dropped out, because of a move abroad.

The study does have limits. All participants were French adults who were already experienced insulin pump users with baseline A1c values between 7 and 11 percent, so the findings may not generalize to people using multiple daily injections or those with very different starting glucose control. Outcomes were exploratory, without pre-specified hypotheses or formal sample-size considerations, and a slight dip in time in range from the end of the randomized phase to the end of the extension may reflect less intensive clinical monitoring, underscoring that ongoing professional support still matters. Even so, the authors conclude that the short-term glycemic, safety, and quality-of-life benefits observed in the controlled trial were faithfully maintained over a full year of routine use, adding to a mounting body of evidence that automated insulin delivery deserves a place as a first-line therapy for people with type 1 diabetes.

Subject of Research: Twelve-month extended use of the tubeless Omnipod 5 automated insulin delivery system in adults with type 1 diabetes

Article Title: Extended Use of the Omnipod 5 Automated Insulin Delivery System in Adults With Type 1 Diabetes: 12‐Month Extension of a Randomized Controlled Trial

Article References: Renard, E., Weinstock, R. S., Penfornis, A., Riveline, J.-P., Thivolet, C., Ly, T. T., & for the OP5‐003 Research Group (2026). Extended Use of the Omnipod 5 Automated Insulin Delivery System in Adults With Type 1 Diabetes: 12‐Month Extension of a Randomized Controlled Trial. Endocrinology, Diabetes & Metabolism, 9(5), Article e70321. https://doi.org/10.1002/edm2.70321

Image Credits: AI Generated

DOI: 10.1002/edm2.70321

Keywords: type 1 diabetes, automated insulin delivery, Omnipod 5, continuous glucose monitoring, time in range, HbA1c, closed-loop insulin pump, hypoglycemia, diabetic ketoacidosis, patient-reported outcomes, randomized controlled trial, diabetes technology