Omnipod 5 preschool cohort (ages 2-5.9)
What this study tests
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.
Editorial review: .
Registry checked: 2026-09-17. Registry’s own update: 2024-02-14.
Source dates appear in the references where available; this record has no dated citation metadata.
Trial status, labels and access can change between reviews. How we review the evidence · How to read the evidence
Evidence at a glance
- Who can enter the study?
- For young children aged 2.0 to 5.9 years with type 1 diabetes who lived with a parent or legal guardian. Entry required an HbA1c below 10% and willingness to use a study-approved rapid-acting insulin (Humalog, NovoLog, Admelog or Apidra) and wear the system continuously. Children were excluded if they had a severe low or diabetic ketoacidosis in the prior 6 months, significant kidney disease, recent steroid use, or certain blood disorders. Registered eligibility ↗Enrollment criteria describe who may enter. They do not establish who was analyzed or the denominator for a reported result.
- Reported benefit and results
- 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.Read the result sources and their limitations →
- Important harms
- Read the reported results, safety discussion and original sources. A separate harms summary is not available; this does not establish safety.
- Research access and approval
- Study regions: United States. A trial listing does not establish product approval or current recruitment at a particular site. Check the study’s current entry requirements.
- What remains uncertain?
- Read the full discussion and original sources for study limitations. Planned endpoints and completion dates are not results.
Research status alone does not establish approval, clinical benefit or local availability. This record cites company or conference reports. Those sources may describe interim findings; their source type is shown in the source list.
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
The full picture
What was tested and why it matters
Toddlers and preschoolers with type 1 diabetes are among the more challenging 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 whether a tubeless automated insulin delivery (AID) system — a wearable patch pump that adjusts insulin automatically based on a continuous glucose monitor — could perform safely and effectively in children as young as two.1
Who it's for
The study enrolled very young children aged 2.0 to 5.9 years living with type 1 diabetes.1 Entry required an HbA1c under 10% and a willingness to wear the system continuously and use a study-approved rapid-acting insulin.2
Design
This was a single-arm, multicenter trial (no control group) at 10 U.S. sites, sponsored by Insulet Corporation.2 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.13 As a device study it was not assigned a conventional drug-trial phase.2
Key results
Over the 13-week phase, HbA1c fell by 0.55% (about 6 mmol/mol).1 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.1 Critically, there were no episodes of severe hypoglycemia and no diabetic ketoacidosis, and the children spent about 97% of the time in automated mode.13 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.3
What it means and what's next
These results showed improved glucose outcomes and few serious events in the studied young children. Following these data, the manufacturer announced 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.4 Because the trial had no comparison group, benefits are measured against each child's own baseline rather than against another treatment.2
Sources
- [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) · Peer-reviewed study
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).
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).
- [2]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) · Trial registry
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).
- [3]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) · Peer-reviewed study
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).
- [4]Insulet Corporation. Insulet Announces FDA Clearance of Omnipod 5 for Children Aged Two Years and Older with Type 1 Diabetes. *Insulet Investor Relations* (2022) · Manufacturer
Insulet Corporation. Insulet Announces FDA Clearance of Omnipod 5 for Children Aged Two Years and Older with Type 1 Diabetes. Insulet Investor Relations (2022).