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type1.science
N/A (device / behavioral)CompletedNCT04196140

Omnipod 5 (Horizon) pivotal single-arm AID trial

What this study tests

The pivotal single-arm trial of the Omnipod 5 tubeless, on-body hybrid closed-loop system in children and adults with type 1 diabetes. It showed improved HbA1c and time-in-range with very low hypoglycemia, and supported the 2022 FDA clearance of the first tubeless automated insulin delivery system.

Editorial review: .

Registry checked: 2026-09-17. Registry’s own update: 2025-04-03.

Most recent recorded citation date: 2024-09-20. Only explicit date metadata is included; an undated citation may be newer. This does not mean every claim was reviewed on that date.

Trial status, labels and access can change between reviews. How we review the evidence · How to read the evidence

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Evidence at a glance

Who can enter the study?
Type 1 diabetes for at least 6 months; HbA1c below 10% at screening; willing to use a study-approved rapid-acting insulin (lispro, aspart, or glulisine). The main pivotal cohort enrolled children aged 6–13.9 years and adolescents/adults aged 14–70 years; a separate cohort studied very young children aged 2–5.9 years. 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
The publication reports 241 enrolled participants (112 children, 129 adolescents/adults); the registry lists 240. Of the publication cohort, 235 (98%) completed the 3-month automated-delivery phase. HbA1c fell by 0.71% in children (7.67% to 6.99%) and by 0.38% in adults (7.16% to 6.78%). Time in range (70–180 mg/dL) rose by 15.6 percentage points (about 3.7 extra hours/day) in children and 9.3 points (about 2.2 hours/day) in adults. Adults also spent less time in hypoglycemia, while children's already-low hypoglycemia held steady. There were three severe hypoglycemia events and one diabetic ketoacidosis event, the severe lows were not attributed to AID malfunction, while DKA followed an infusion-site failure. A 2-year extension showed these glycemic gains were maintained, with participants spending about 96% of time in automated mode. The extension reported seven severe hypoglycemia events and one DKA event.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 during the automated insulin delivery phase (safety)
  • Incidence of diabetic ketoacidosis during the automated insulin delivery phase (safety)
  • Change in HbA1c from the standard-therapy phase to the automated insulin delivery phase (effectiveness)
  • Change in percent time in sensor glucose range 70–180 mg/dL (time in range) from standard therapy to automated insulin delivery (effectiveness)

The full picture

What was tested and why it matters

This was the pivotal clinical trial behind Omnipod 5 (originally called Omnipod Horizon), the first tubeless, on-body automated insulin delivery (AID) system.1 An AID system — sometimes called a hybrid closed-loop or "artificial pancreas" — links a continuous glucose monitor (CGM) to an insulin pump and uses an algorithm to automatically adjust insulin. What made Omnipod 5 different is that the control algorithm (called SmartAdjust) lives inside the disposable pod worn on the body, with no tubing and no separate handheld pump.1 Every 5 minutes it reads the Dexcom G6 CGM, predicts glucose 60 minutes ahead, and then raises, lowers, or pauses insulin toward a target the user can customize.2

Who it was for

The main study enrolled people with type 1 diabetes for at least 6 months and an HbA1c (a 3-month average blood-sugar measure) below 10%.1 The pivotal cohort covered children aged 6–13.9 years and adolescents/adults aged 14–70 years; a separate arm later studied very young children aged 2–5.9 years.13

Design

This was a single-arm, multicenter, prospective study — every participant used the system and was compared against their own earlier standard care, with no randomized control group.1 After a 2-week phase on participants' usual insulin regimen, they used Omnipod 5 for 3 months.1 The publication reports 241 participants (112 children and 129 adolescents/adults), with 235 completing; the registry lists 240. These are source-specific counts.1 The trial ran across U.S. sites and was sponsored by Insulet Corporation.4

Key results

HbA1c dropped by 0.71% in children (from 7.67% to 6.99%) and 0.38% in adults (from 7.16% to 6.78%).1 Time in the target range of 70–180 mg/dL improved by 15.6 percentage points (about 3.7 extra hours per day) in children and 9.3 points (about 2.2 hours per day) in adults.1 Adults also spent less time low (hypoglycemic), while children's already-low time-low stayed flat.1 Safety was reassuring: only three severe hypoglycemia events and one case of diabetic ketoacidosis, the severe lows were not attributed to AID malfunction, and DKA followed an infusion-site failure.1 A later 2-year extension found these benefits held up, with participants in automated mode about 96% of the time. Seven severe hypoglycemia events and one DKA event occurred during the extension.5

What it means and what's next

These results supported the FDA clearance of Omnipod 5 on January 28, 2022.12 The company's release described it as the first tubeless system with smartphone control.2 The system has since been studied in very young children,3 but later clearance extensions are outside this record's cited sources. As a single-arm study its design cannot fully separate the device's effect from the extra attention of a trial, but the consistency, durability, and strong safety record make it a landmark in everyday "artificial pancreas" technology.

Sources

  1. [1]
    Multicenter Trial of a Tubeless, On-Body Automated Insulin Delivery System With Customizable Glycemic Targets in Pediatric and Adult Participants With Type 1 Diabetes. · Peer-reviewed study · 2021-06-07

    Brown SA, Forlenza GP, Bode BW, et al. Multicenter Trial of a Tubeless, On-Body Automated Insulin Delivery System With Customizable Glycemic Targets in Pediatric and Adult Participants With Type 1 Diabetes. Diabetes Care (2021); 44(7):1630–1640.

  2. [2]
    Insulet Corporation. Insulet Announces FDA Clearance of its Omnipod 5 Automated Insulin Delivery System, First Tubeless System with Smartphone Control (press release). *Insulet Investor Relations* (2022) · Manufacturer

    Insulet Corporation. Insulet Announces FDA Clearance of its Omnipod 5 Automated Insulin Delivery System, First Tubeless System with Smartphone Control (press release). Insulet Investor Relations (2022).

    Insulet Corporation. Insulet Announces FDA Clearance of its Omnipod 5 Automated Insulin Delivery System, First Tubeless System with Smartphone Control (press release, January 28, 2022). Insulet Investor Relations (2022).

  3. [3]
    Psychosocial outcomes with the Omnipod® 5 Automated Insulin Delivery System in caregivers of very young children with type 1 diabetes. · Peer-reviewed study · 2024-09-20

    MacLeish SA, Hood KK, Polonsky WH, et al. Psychosocial outcomes with the Omnipod 5 Automated Insulin Delivery System in caregivers of very young children with type 1 diabetes. Diabetes, Obesity & Metabolism (2024); 26(12):5569–5579.

  4. [4]
    U.S. National Library of Medicine. Evaluating the Safety and Effectiveness of the Omnipod Horizon Automated Glucose Control System in Patients With Type 1 Diabetes (NCT04196140). *ClinicalTrials.gov* (2022) · Trial registry

    U.S. National Library of Medicine. Evaluating the Safety and Effectiveness of the Omnipod Horizon Automated Glucose Control System in Patients With Type 1 Diabetes (NCT04196140). ClinicalTrials.gov (2022).

  5. [5]
    Two Years with a Tubeless Automated Insulin Delivery System: A Single-Arm Multicenter Trial in Children, Adolescents, and Adults with Type 1 Diabetes. · Peer-reviewed study · 2023-11-30

    Criego AB, Carlson AL, Brown SA, et al. Two Years with a Tubeless Automated Insulin Delivery System: A Single-Arm Multicenter Trial in Children, Adolescents, and Adults with Type 1 Diabetes. Diabetes Technology & Therapeutics (2024); 26(1):11–23.