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Pilot / feasibilityCompletedNCT04476472

Omnipod 5 preschool cohort (ages 2-5.9)

Single-arm multicenter trial that tested the tubeless Omnipod 5 automated insulin delivery system in 80 very young children (ages 2.0-5.9) with type 1 diabetes. Over 13 weeks it lowered HbA1c by 0.55% and added ~2.6 hours/day in target range with no severe hypoglycemia or DKA; an extension showed benefits held for up to 2 years. The data supported the August 2022 FDA clearance extending Omnipod 5 down to age 2.

Primary endpoints

  • Incidence of severe hypoglycemia (events per person-month)
  • Incidence of diabetic ketoacidosis (events per person-month)
  • Change in HbA1c from baseline to end of the 13-week closed-loop phase
  • Change in percent time in target glucose range (70-180 mg/dL) versus the standard-therapy baseline

Results so far

Across 80 children, 13 weeks on Omnipod 5 lowered HbA1c by 0.55% (from 7.4% to about 6.9%) and raised time in target range (70-180 mg/dL) by 10.9% — roughly 2.6 extra hours per day in range — while time spent low (<70 mg/dL) fell slightly, with no episodes of severe hypoglycemia or diabetic ketoacidosis. Children spent about 97% of the time in automated mode. In the extension (median ~18 months, up to 2 years of use), HbA1c stayed around 7.0% and time in range held near 67%, with only one severe low and one DKA episode recorded.

The full picture

What was tested and why it matters

Toddlers and preschoolers with type 1 diabetes are one of the hardest groups to manage. Their food intake and activity are unpredictable, they often cannot say when they feel low, and caregivers face round-the-clock vigilance to avoid dangerous blood-sugar swings.1 This trial asked a simple question: could a tubeless automated insulin delivery (AID) system — a wearable patch pump that adjusts insulin automatically based on a continuous glucose monitor — work safely in children as young as two?2

Who it's for

The study enrolled very young children aged 2.0 to 5.9 years living with type 1 diabetes.2 Entry required an HbA1c under 10% and a willingness to wear the system continuously and use a study-approved rapid-acting insulin.3

Design

This was a single-arm, multicenter trial (no control group) at 10 U.S. sites, sponsored by Insulet Corporation.3 Eighty children first completed 14 days on their usual therapy to set a baseline, then used the Omnipod 5 (then called Omnipod Horizon) system in hybrid closed-loop mode for 13 weeks, with an optional extension of up to about two years.24 As a device study it was not assigned a conventional drug-trial phase.3

Key results

Over the 13-week phase, HbA1c fell by 0.55% (about 6 mmol/mol).2 Time in the target range of 70–180 mg/dL rose by 10.9% — roughly 2.6 extra hours per day in range — and time spent low (under 70 mg/dL) dropped slightly.2 Critically, there were no episodes of severe hypoglycemia and no diabetic ketoacidosis, and the children spent about 97% of the time in automated mode.24 In the extension study (median ~18 months of use, up to 2 years), HbA1c held near 7.0% and time in range stayed around 67%, with only one severe low and one DKA episode across the whole period.4

What it means and what's next

These results showed that a tubeless artificial-pancreas system could safely improve glucose control in the youngest children — a population that had been left out of earlier AID approvals. The data directly supported the U.S. FDA clearance, on 22 August 2022, of Omnipod 5 for ages 2 and older, extending the lower age limit from six years.5 Because the trial had no comparison group, benefits are measured against each child's own baseline rather than against another treatment.3

References

  1. Sherr JL, et al. Safety and Glycemic Outcomes With a Tubeless Automated Insulin Delivery System in Very Young Children With Type 1 Diabetes: A Single-Arm Multicenter Clinical Trial. Diabetes Care (2022). https://pubmed.ncbi.nlm.nih.gov/35678724/ ↩

  2. Sherr JL, et al. Safety and Glycemic Outcomes With a Tubeless Automated Insulin Delivery System in Very Young Children With Type 1 Diabetes. Diabetes Care 45(8):1907-1910 (2022). https://pubmed.ncbi.nlm.nih.gov/35678724/ ↩ ↩2 ↩3 ↩4 ↩5 ↩6

  3. Insulet Corporation. Evaluating the Safety and Effectiveness of the Omnipod Horizon Automated Glucose Control System in Children With Type 1 Diabetes Aged 2.0-5.9 Years (NCT04476472). ClinicalTrials.gov (2022). https://clinicaltrials.gov/study/NCT04476472 ↩ ↩2 ↩3 ↩4

  4. DeSalvo DJ, et al. Glycemic Outcomes Persist for up to 2 Years in Very Young Children with the Omnipod 5 Automated Insulin Delivery System. Diabetes Technology & Therapeutics 26(6):383-393 (2024). https://pmc.ncbi.nlm.nih.gov/articles/PMC12776363/ ↩ ↩2 ↩3

  5. Insulet Corporation. Insulet Announces FDA Clearance of Omnipod 5 for Children Aged Two Years and Older with Type 1 Diabetes. Insulet Investor Relations (2022). https://investors.insulet.com/news/news-details/2022/Insulet-Announces-FDA-Clearance-of-Omnipod-5-for-Children-Aged-Two-Years-and-Older-with-Type-1-Diabetes/default.aspx ↩