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Pilot / feasibilityCompletedNCT04196140

Omnipod 5 (Horizon) pivotal single-arm AID trial

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.

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)

Results so far

Among 240 enrolled participants (112 children, 129 adolescents/adults), 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, none caused by the algorithm. A 2-year extension showed these glycemic gains were maintained, with participants spending about 96% of time in automated mode.

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 pivotal cohort enrolled 240 participants (112 children and 129 adolescents/adults), and 235 (98%) completed.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, none caused by an algorithm malfunction.1 A later 2-year extension found these benefits held up, with participants in automated mode about 96% of the time.5

What it means and what's next

These results supported the FDA clearance of Omnipod 5 on January 28, 2022 — the first tubeless AID system with smartphone control.6 The system has since been cleared for younger children and, later, for adults with type 2 diabetes.6 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.

References

  1. 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. https://doi.org/10.2337/dc21-0172 ↩ ↩2 ↩3 ↩4 ↩5 ↩6 ↩7 ↩8 ↩9 ↩10 ↩11

  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). https://investor.insulet.com/news/news-details/2022/Insulet-Announces-FDA-Clearance-of-its-Omnipod-5-Automated-Insulin-Delivery-System-First-Tubeless-System-with-Smartphone-Control/default.aspx ↩

  3. 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. https://doi.org/10.1111/dom.15906 ↩

  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). https://clinicaltrials.gov/study/NCT04196140 ↩

  5. 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. https://doi.org/10.1089/dia.2023.0364 ↩

  6. 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). https://investor.insulet.com/news/news-details/2022/Insulet-Announces-FDA-Clearance-of-its-Omnipod-5-Automated-Insulin-Delivery-System-First-Tubeless-System-with-Smartphone-Control/default.aspx ↩ ↩2