Who is sponsoring NCT04476472?

NCT04476472 is sponsored by Insulet Corporation.

What drugs are being tested in NCT04476472?

Interventions in NCT04476472: Omnipod Horizon™ Automated Glucose Control System.

What condition does NCT04476472 study?

NCT04476472 studies Type 1 Diabetes Mellitus.

Is NCT04476472 still recruiting?

NCT04476472 is currently completed. Last updated 14 February 2024.

Are results published for NCT04476472?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-02-14 · How we verify

NCT04476472

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Omnipod Horizon™ Automated Glucose Control System Preschool Cohort

Completed NA Results posted Last updated 14 February 2024

What this trial tests

NA trial testing Omnipod Horizon™ Automated Glucose Control System in Type 1 Diabetes Mellitus in 80 participants. Completed in 12 October 2022.

Timeline

8 September 2020

Primary endpoint
17 January 2022

12 October 2022

Quick facts

Lead sponsor	Insulet Corporation
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	80
Start date	8 September 2020
Primary completion	17 January 2022
Estimated completion	12 October 2022
Sites	10 locations across United States

Drugs / interventions tested

Omnipod Horizon™ Automated Glucose Control System

Conditions studied

Type 1 Diabetes Mellitus — all drugs for Type 1 Diabetes Mellitus →

Sponsor

Insulet Corporation — full company profile →

Who can join

Adults 2 to 5, any sex, with Type 1 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Incidence Rate of Severe Hypoglycemia (Events Per Person Months) Primary · Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days)

Number of severe hypoglycemia events reported in "events per person months" units.

Phase 2

Group	Value	95% CI
Treatment	0

Phase 3

Group	Value	95% CI
Treatment	0.0007

Incidence Rate of Diabetic Ketoacidosis (DKA) (Events Per Person Months) Primary · Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days)

Number of DKA events reported in "events per person months" units.

Phase 2

Group	Value	95% CI
Treatment	0

Phase 3

Group	Value	95% CI
Treatment	0.0007

Glycated Hemoglobin (A1C) Primary · Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (180 days, 270 days, 360 days, and 450 days) compared to baseline

Measures device effectiveness

Baseline

Group	Value	95% CI
Treatment	7.4	± 1.0

V13

Group	Value	95% CI
Treatment	6.9	± 0.7

V16

Group	Value	95% CI
Treatment	7.0	± 0.7

V19

Group	Value	95% CI
Treatment	7.1	± 0.7

V21

Group	Value	95% CI
Treatment	6.9	± 0.7

V23

Group	Value	95% CI
Treatment	7.0	± 0.7

Time in Range 70-180 mg/dL Primary · Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days)

Measures device effectiveness

Day Time ST

Group	Value	95% CI
Treatment	56.9	± 15.2

Day Time Phase 2

Group	Value	95% CI
Treatment	63.7	± 9.7

Day Time Phase 3

Group	Value	95% CI
Treatment	63.5	± 9.8

Night Time ST

Group	Value	95% CI
Treatment	58.2	± 18.7

Night Time Phase 2

Group	Value	95% CI
Treatment	81.0	± 10.0

Night Time Phase 3

Group	Value	95% CI
Treatment	78.2	± 10.4

Overall ST

Group	Value	95% CI
Treatment	57.2	± 15.3

Overall Phase 2

Group	Value	95% CI
Treatment	68.1	± 9.0

Glycated Hemoglobin (A1C) Secondary · Hybrid closed-loop (94 days, 180 days, 270 days, and 450 days) compared to baseline

Measures device effectiveness

Baseline

Group	Value	95% CI
Treatment	7.4	± 1.0

V13

Group	Value	95% CI
Treatment	6.9	± 0.7

V16

Group	Value	95% CI
Treatment	7.0	± 0.7

V19

Group	Value	95% CI
Treatment	7.1	± 0.7

V21

Group	Value	95% CI
Treatment	6.9	± 0.7

V23

Group	Value	95% CI
Treatment	7.0	± 0.7

Percent of Time in Range 70-140 mg/dL Secondary · Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall

Glucose metric from study continuous glucose monitoring system (CGM)

Day Time ST

Group	Value	95% CI
Treatment	36.2	± 13.2

Day Time Phase 2

Group	Value	95% CI
Treatment	41.3	± 9.4

Day Time Phase 3

Group	Value	95% CI
Treatment	41.2	± 9.8

Night Time ST

Group	Value	95% CI
Treatment	36.7	± 16.9

Night Time Phase 2

Group	Value	95% CI
Treatment	57.7	± 13.7

Night Time Phase 3

Group	Value	95% CI
Treatment	53.9	± 13.1

Overall ST

Group	Value	95% CI
Treatment	36.3	± 13.4

Overall Phase 2

Group	Value	95% CI
Treatment	45.4	± 9.7

Percent of Time > 180 mg/dL Secondary · Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall

Glucose metric from study continuous glucose monitoring system (CGM)

Day Time ST

Group	Value	95% CI
Treatment	39.7	± 16.6

Day Time Phase 2

Group	Value	95% CI
Treatment	33.7	± 10.7

Day Time Phase 3

Group	Value	95% CI
Treatment	33.7	± 10.8

Night Time ST

Group	Value	95% CI
Treatment	38.4	± 20.1

Night Time Phase 2

Group	Value	95% CI
Treatment	16.9	± 10.3

Night Time Phase 3

Group	Value	95% CI
Treatment	19.7	± 10.6

Overall ST

Group	Value	95% CI
Treatment	39.4	± 16.7

Overall Phase 2

Group	Value	95% CI
Treatment	29.5	± 9.8

Percent of Time ≥ 250 mg/dL Secondary · Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall

Glucose metric from study continuous glucose monitoring system (CGM)

Day Time ST

Group	Value	95% CI
Treatment	15.4	± 12.7

Day Time Phase 2

Group	Value	95% CI
Treatment	11.0	± 6.6

Day Time Phase 3

Group	Value	95% CI
Treatment	11.5	± 6.9

Night Time ST

Group	Value	95% CI
Treatment	13.0	± 13.2

Night Time Phase 2

Group	Value	95% CI
Treatment	3.9	± 3.9

Night Time Phase 3

Group	Value	95% CI
Treatment	5.1	± 4.6

Overall ST

Group	Value	95% CI
Treatment	14.8	± 12.1

Overall Phase 2

Group	Value	95% CI
Treatment	9.2	± 5.6

Percent of Time ≥ 300 mg/dL Secondary · Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall

Glucose metric from study continuous glucose monitoring system (CGM)

Day Time ST

Group	Value	95% CI
Treatment	6.5	± 8.0

Day Time Phase 2

Group	Value	95% CI
Treatment	3.9	± 3.4

Day Time Phase 3

Group	Value	95% CI
Treatment	4.4	± 3.8

Night Time ST

Group	Value	95% CI
Treatment	4.3	± 6.7

Night Time Phase 2

Group	Value	95% CI
Treatment	1.2	± 1.6

Night Time Phase 3

Group	Value	95% CI
Treatment	1.8	± 2.1

Overall ST

Group	Value	95% CI
Treatment	6.0	± 7.3

Overall Phase 2

Group	Value	95% CI
Treatment	3.2	± 2.8

Percent of Time < 70 mg/dL Secondary · Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall

Glucose metric from study continuous glucose monitoring system (CGM)

Day Time ST

Group	Value	95% CI
Treatment	3.44	± 3.85

Day Time Phase 2

Group	Value	95% CI
Treatment	2.57	± 1.99

Day Time Phase 3

Group	Value	95% CI
Treatment	2.79	± 1.98

Night Time ST

Group	Value	95% CI
Treatment	3.41	± 4.79

Night Time Phase 2

Group	Value	95% CI
Treatment	2.13	± 1.94

Night Time Phase 3

Group	Value	95% CI
Treatment	2.06	± 1.70

Overall ST

Group	Value	95% CI
Treatment	3.43	± 3.87

Overall Phase 2

Group	Value	95% CI
Treatment	2.46	± 1.83

Percent of Time < 54 mg/dL Secondary · Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall

Glucose metric from study continuous glucose monitoring system (CGM)

Day Time ST

Group	Value	95% CI
Treatment	0.80	± 1.67

Day Time Phase 2

Group	Value	95% CI
Treatment	0.50	± 0.61

Day Time Phase 3

Group	Value	95% CI
Treatment	0.59	± 0.63

Night Time ST

Group	Value	95% CI
Treatment	0.85	± 1.94

Night Time Phase 2

Group	Value	95% CI
Treatment	0.39	± 0.53

Night Time Phase 3

Group	Value	95% CI
Treatment	0.49	± 0.63

Overall ST

Group	Value	95% CI
Treatment	0.81	± 1.68

Overall Phase 2

Group	Value	95% CI
Treatment	0.47	± 0.54

Mean Glucose Secondary · Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall

Glucose metric from study continuous glucose monitoring system (CGM)

Day Time ST

Group	Value	95% CI
Treatment	172.2	± 31.3

Day Time Phase 2

Group	Value	95% CI
Treatment	163.0	± 18.3

Day Time Phase 3

Group	Value	95% CI
Treatment	163.6	± 19.3

Night Time ST

Group	Value	95% CI
Treatment	168.1	± 33.3

Night Time Phase 2

Group	Value	95% CI
Treatment	140.7	± 16.4

Night Time Phase 3

Group	Value	95% CI
Treatment	145.7	± 16.9

Overall ST

Group	Value	95% CI
Treatment	171.1	± 30.5

Overall Phase 2

Group	Value	95% CI
Treatment	157.4	± 16.8

Adverse events — posted to ClinicalTrials.gov

Time frame: First day of standard therapy phase until participant's participation in study ended, an average of 15 weeks.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment

Serious: 4/80 (5%)

Deaths: 0/80

Serious adverse events (4 terms)

Reaction	System	Treatment
Severe hypoglycemia	Endocrine disorders	—
Diabetic ketoacidosis	Endocrine disorders	—
Prolonged Hyperglycemia	Endocrine disorders	—
Other	Gastrointestinal disorders	—

Other adverse events (4 terms — click to expand)

Reaction	System	Treatment
Other	Endocrine disorders	—
Prolonged Hyperglycemia	Endocrine disorders	—
Hyperglycemia	Endocrine disorders	—
Hypoglycemia	Endocrine disorders	—

Most-reported serious reactions: Severe hypoglycemia, Diabetic ketoacidosis, Prolonged Hyperglycemia, Other.

Data from ClinicalTrials.gov NCT04476472 adverse events section.

Sponsor's own description

Subjects will undergo a 14-day outpatient, standard therapy phase during which sensor and insulin data will be collected. This will be followed by a 94-day (13-week) hybrid closed-loop phase conducted in an outpatient setting, and an optional 12-month extension phase.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

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.
Sherr JL, Bode BW, Forlenza GP, Laffel LM, et al · · 2022 · cited 66× · PMID 35678724 · DOI 10.2337/dc21-2359
Clinical Implementation of the Omnipod 5 Automated Insulin Delivery System: Key Considerations for Training and Onboarding People With Diabetes.
Berget C, Sherr JL, DeSalvo DJ, Kingman RS, et al · · 2022 · cited 23× · PMID 35669307 · DOI 10.2337/cd21-0083
Glycemic Outcomes Persist for up to 2 Years in Very Young Children with the Omnipod<sup>®</sup> 5 Automated Insulin Delivery System.
DeSalvo DJ, Bode BW, Forlenza GP, Laffel LM, et al · · 2024 · cited 20× · PMID 38277156 · DOI 10.1089/dia.2023.0506
Psychosocial outcomes with the Omnipod® 5 Automated Insulin Delivery System in caregivers of very young children with type 1 diabetes.
MacLeish SA, Hood KK, Polonsky WH, Wood JR, et al · · 2024 · cited 6× · PMID 39300963 · DOI 10.1111/dom.15906
58<sup>th</sup> EASD Annual Meeting of the European Association for the Study of Diabetes : Stockholm, Sweden, 19 - 23 September 2022.
· 2022 · cited 6× · PMID 35920845 · DOI 10.1007/s00125-022-05755-w

Verify or expand the search:

Other trials of Omnipod Horizon™ Automated Glucose Control System

Trials testing the same drug.

NCT04320069 — Continuous Glucose Monitoring System (CGM)-Informed Bolus Calculator Study · NA · completed
NCT04196140 — Pivotal Omnipod Horizon™ Automated Glucose Control System · NA · completed
NCT04176731 — Prepivotal Omnipod Horizon™ Automated Glucose Control System · NA · completed

Other recruiting trials for Type 1 Diabetes Mellitus

Currently open trials in the same condition.

NCT07142252 — Rezpegaldesleukin (NKTR-358) in New Onset Type 1 Diabetes Mellitus · Phase 2 · recruiting
NCT07296276 — Accuracy and Precision of the Continuous Glucose Monitoring System 'CareSens Air 3' in Adult Patients With T1DM · NA · recruiting
NCT07409701 — Gamification Intervertion in Children With Type 1 Diabetes · NA · recruiting
NCT07356089 — Twiist Postmarket Surveillance Study for Type 1 Diabetes · recruiting
NCT07434154 — Evaluation of Oxidative Stress: Comparison Between Type 1 Diabetes Mellitus and Latent Autoimmune Diabetes in Adults · recruiting

Other Insulet Corporation trials

Trials by the same sponsor.

NCT07521475 — Evaluation of the Fully Closed Loop Omnipod® System in Type 2 Diabetes · NA · not yet recruiting
NCT07276776 — An Evaluation of the Omnipod® M System in Adults With Type 2 Diabetes · NA · active not recruiting
NCT07070830 — Simplified Onboarding in Adults With Type 2 Diabetes · NA · completed
NCT06865989 — Omnipod® SmartAdjust 2.0 System Compared to the Omnipod® 5 System in Individuals With Type 1 or Type 2 Diabetes · NA · completed
NCT06547918 — SmartAdjust 2.0 System With Type 1 and Type 2 Diabetes · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04476472 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Insulet Corporation
Last refreshed: 14 February 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04476472.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT04476472

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (4 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of Omnipod Horizon™ Automated Glucose Control System

Other recruiting trials for Type 1 Diabetes Mellitus

Other Insulet Corporation trials

Verify against primary sources