Omnipod® 5 Shows Significant Improvements in Glycemic Measures and Diabetes Distress

Brenda Ferris, MS, RD, CDCES, CDN *
Category: Tips & Guidelines

Omnipod 5 is the first automated insulin delivery system (AID) FDA cleared for patients with type 2 diabetes in the US. It is also the first and only tubeless AID system in the US. A single arm, multicenter prospective study by Pasquel et al. evaluated the safety and efficacy of the Omnipod 5 AID System in adults with type 2 diabetes. 1

 

Key Takeaways

  • Omnipod 5 lowered A1C regardless of patient race, ethnicity, GLP-1 use and whether they were carb counting or not. In patients with a baseline of A1C ≥9%, the A1C was lowered by 2.1% (-0.8 in full study population)
  • Participants spent more time in range by nearly 5 hours a day (% of time spent between 70-180 mg/dL)
  • No increase in time in hypoglycemia (% time spent <70 mg/dL)
  • 29% reduction in insulin need
  • Significant reduction in patient-reported distress related to diabetes, and improved quality of sleep were observed

 

Study Overview

The study consisted of a standard therapy phase of 14 days where participants continued using their pre-study therapy. During this time, investigators assessed insulin dosing at mealtimes and provided carbohydrate counting education or advised participants to use a simplified meal bolus strategy (ex: small, medium and large, fixed dose, or correction-only). Following that, participants transitioned to the 13-week treatment phase using the Omnipod 5 AID System.

The study design purposely defined enrollment goals to enroll a higher proportion of non-white participants to encompass communities affected by social determinants of health, who also have higher prevalence rates of diabetes and have often been underrepresented in clinical trials as shown in Figure 1.

Participants were aged 18-75 years and treated with a stable insulin regimen for at least 3 months prior to screening. They could additionally be treated with other antihyperglycemic and weight loss medications without dose changes for at least 4 weeks prior to the trial. All participants were required to have a baseline A1c of less than 12%, and for basal insulin only users, there was lower A1c limit of 7%. There was no limit to the participants’ total daily insulin dose.

Of the 305 initiating AID, prior therapy diversity at baseline included:

  • 73% on MDI
  • 6% on an insulin pump without AID
  • 21% on basal insulin only
  • 68% were using CGM
  • 55% on GLP-1RA
  • 44% on SGLT-2i
  • 27% on both GLP-1RA and SGLT-2i
  • 41% of the participants had publicly funded insurance or no health insurance


Figure 1. Diverse Study Cohort Representative of US Population with Type 2 Diabetes

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The primary outcome was the change in A1C, at 13 weeks from baseline. Secondary outcomes included percentage of time with sensor glucose in ranges of interest (70-180 mg/dL - Time in Range, below 70mg/dL -Time Below Range, and greater than 180 mg/dL - Time Above Range)

 

Results Summary

A1C decreased by a mean of 0.8%, from 8.2% at baseline to 7.4% at the end of the 13-week treatment phase. While a reduction observed across a wide range of participants, a greater decrease of 2.1% was seen among those who started at baseline with a higher A1C (9%) as shown in Figure 2.

 

Figure 2. A1C Significantly Reduced With Omnipod 5—Greater A1C Reduction Among Participants with Higher Baseline A1C Levels
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A similar change in A1C was observed among subgroups based on sex, age, socioeconomic status, pre-trial mealtime insulin regimen, non-insulin glucose-lowering medication use (Figure 3), C-peptide level, and previous CGM use as shown in Figure 4. Change in A1C data seen in Figures 3 & 4 represent unadjusted mean.

 

Figure 3.  A1C Reduction in GLP-1 RA Users and Non-Users
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Figure 4.  A1C Reduction in Both CGM Users and Non-Users
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Additionally, participants who did not count carbohydrates, and used simplified meal bolus strategies, still experienced an improvement in A1C, indicating that carb counting isn’t a prerequisite for initiating AID or for improvement. (Figure 5)3

 

Figure 5.  Carbohydrate Counting is not a Prerequisite for Omnipod 5
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Time in range (70-180 mg/dL) was significantly improved by 20% accounting for an additional 4.8 hours per day in target range. These glycemic improvements were achieved with no increase in hypoglycemia as shown in Figure 6.

 

Figure 6.  Significant TIR Improvement; No Increase in Time in Hypoglycemia
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There was a significant reduction in patient-reported distress related to diabetes. The percentage of participants with high distress decreased from 66% at baseline to 55% at the end of the treatment phase.

During the treatment phase, there were no serious adverse device effects. There was 1 severe hypoglycemic event, deemed unrelated to malfunction of the trial device and no case of DKA or HHS.

The authors point out that the notable strength of this trial includes the large and diverse population recruited with varying racial/ethnic backgrounds, prior insulin regimen and medication use, representing the diverse general population with type 2 diabetes. Compared with the general US population, this study sample was similar in terms of education level, insurance, and skewed slightly more to the lower household income range, likely due to higher mean age. The study did have a limitation in its single arm design that did not include a concurrent control group.

The American Diabetes Association's 2025 Standards of Care in Diabetes recommend insulin pumps for insulin-requiring type 2 diabetes. The ADA recognizes that AID systems are preferred over nonautomated insulin pumps for those with type 1 diabetes, and that real-world studies have also shown benefits of AID technology in adults with type 22. The SECURE-T2D study illustrates that a wide range of adults with type 2 diabetes could benefit from Omnipod 5.

For insights about expanding patient selection for AID, hear from Dr. Shah as he discusses the SECURE-T2D study in detail.

Learn More

1. Pasquel FJ, Davis GM, Huffman DM, et al. Automated Insulin Delivery in Adults With Type 2 Diabetes: A Nonrandomized Clinical Trial. JAMA Netw Open. 2025;8(2):e2459348. doi:10.1001/jamanetworkopen.2024.59348

2. American Diabetes Association Professional Practice Committee; 7. Diabetes Technology: Standards of Care in Diabetes—2025. Diabetes Care 1 January 2025; 48 (Supplement_1): S146–S166. https://doi.org/10.2337/dc25-S007

3. Data shown as unadjusted mean, results from participant reported survey. Pasquel FJ, et al. Omnipod 5 Product Theater. Presented at: ADA; June 21-24, 2024; Orlando, FL. Post-hoc analysis limits conclusions.