NCT04196140

Pivotal Omnipod Horizon™ Automated Glucose Control System

Completed NA Results posted Last updated 3 April 2025

What this trial tests

NA trial testing Omnipod Horizon™ Automated Glucose Control System in Type 1 Diabetes Mellitus in 240 participants. Completed in 20 April 2022.

Timeline

30 December 2019

Primary endpoint
10 July 2020

20 April 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	240
Start date	30 December 2019
Primary completion	10 July 2020
Estimated completion	20 April 2022
Sites	16 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 6 to 70, 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)

Measure of serious device-related adverse events

Group	Value	95% CI
Treatment	.004

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

Measure of serious device-related adverse events

Group	Value	95% CI
Treatment	.001

Glycated Hemoglobin (A1C) Primary · 6 weeks continuous Phase 2 participation compared to baseline

Measures device effectiveness

Baseline

Group	Value	95% CI
Treatment	7.4	± 0.9

Phase 2

Group	Value	95% CI
Treatment	6.9	± 0.7

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

Measures device effectiveness

Day Time ST

Group	Value	95% CI
Treatment	58.6	± 17.5

Day Time Phase 2

Group	Value	95% CI
Treatment	68.8	± 10.7

Night Time ST

Group	Value	95% CI
Treatment	60.1	± 19.8

Night Time Phase 2

Group	Value	95% CI
Treatment	78.1	± 12.6

Overall ST

Group	Value	95% CI
Treatment	59.0	± 17.2

Overall Phase 2

Group	Value	95% CI
Treatment	71.2	± 10.2

Percent of Time >180 mg/dL Secondary · Phase 2 hybrid closed-loop (94 days) compared to Phase 1 standard therapy (14 days)

Glucose metric from study continuous glucose monitoring system (CGM)

Day Time ST

Group	Value	95% CI
Treatment	39	± 18.4

Day Time HCL

Group	Value	95% CI
Treatment	29.5	± 11

Night Time ST

Group	Value	95% CI
Treatment	36.8	± 20.7

Night Time HCL

Group	Value	95% CI
Treatment	20.7	± 12.6

Overall ST

Group	Value	95% CI
Treatment	38.5	± 18.1

Overall HCL

Group	Value	95% CI
Treatment	27.3	± 10.5

Percent of Time <70 mg/dL Secondary · Phase 2 hybrid closed-loop (94 days) compared to Phase 1 standard therapy (14 days)

Glucose metric from study continuous glucose monitoring system (CGM)

Day Time ST

Group	Value	95% CI
Treatment	2.4	± 2.78

Day Time HCL

Group	Value	95% CI
Treatment	1.66	± 1.38

Night Time ST

Group	Value	95% CI
Treatment	3.11	± 4.39

Night Time HCL

Group	Value	95% CI
Treatment	1.17	± 1.23

Overall ST

Group	Value	95% CI
Treatment	2.57	± 2.90

Overall HCL

Group	Value	95% CI
Treatment	1.53	± 1.25

Glycated Hemoglobin (A1C) Secondary · at least 6 weeks and at least 8 weeks of continuous Phase 2 participation, end of Phase 2 (94 days), 6 months (180 days) and end of Phase 3 (270 days)

Measures device effectiveness

6 Weeks Baseline

Group	Value	95% CI
Treatment	7.4	± 0.9

6 Weeks Phase 2

Group	Value	95% CI
Treatment	6.7	± 0.6

8 Weeks Baseline

Group	Value	95% CI
Treatment	7.4	± 0.9

8 Weeks Phase 2

Group	Value	95% CI
Treatment	6.9	± 0.7

6 months

Group	Value	95% CI
Treatment	6.8	± 0.6

12 months

Group	Value	95% CI
Treatment	7.1	± 0.7

Mean Glucose Secondary · Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 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	172.7	± 32.2

Day Time Phase 2

Group	Value	95% CI
Treatment	159.4	± 17.1

Day Time Phase 3

Group	Value	95% CI
Treatment	162.2	± 19.7

Night Time ST

Group	Value	95% CI
Treatment	167.8	± 35.4

Night Time Phase 2

Group	Value	95% CI
Treatment	148.9	± 19.2

Night Time Phase 3

Group	Value	95% CI
Treatment	150.8	± 19.3

Overall ST

Group	Value	95% CI
Treatment	171.5	± 31.7

Overall Phase 2

Group	Value	95% CI
Treatment	156.7	± 16.3

Percent of Time in Range 70-180 mg/dL Secondary · Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 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	58.6	± 17.5

Day Time Phase 2

Group	Value	95% CI
Treatment	68.8	± 10.7

Day Time Phase 3

Group	Value	95% CI
Treatment	67.0	± 11.5

Night Time ST

Group	Value	95% CI
Treatment	60.1	± 19.8

Night Time Phase 2

Group	Value	95% CI
Treatment	78.1	± 12.6

Night Time Phase 3

Group	Value	95% CI
Treatment	76.6	± 12.5

Overall ST

Group	Value	95% CI
Treatment	59.0	± 17.2

Overtime Phase 2

Group	Value	95% CI
Treatment	71.2	± 10.2

Percent of Time in Range 70-140 mg/dL Secondary · Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 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	36.0	± 15.3

Day Time Phase 2

Group	Value	95% CI
Treatment	43.7	± 10.6

Day Time Phase 3

Group	Value	95% CI
Treatment	42.6	± 11.1

Night Time ST

Group	Value	95% CI
Treatment	38.2	± 19.0

Night Time Phase 2

Group	Value	95% CI
Treatment	52.8	± 15.5

Night Time Phase 3

Group	Value	95% CI
Treatment	51.9	± 14.4

Overall ST

Group	Value	95% CI
Treatment	36.6	± 15.4

Overall Phase 2

Group	Value	95% CI
Treatment	46.0	± 10.7

Percent of Time >180 mg/dL Secondary · Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 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	39.0	± 18.4

Day Time Phase 2

Group	Value	95% CI
Treatment	29.5	± 11.0

Day Time Phase 3

Group	Value	95% CI
Treatment	31.3	± 11.9

Night Time ST

Group	Value	95% CI
Treatment	36.8	± 20.7

Night Time Phase 2

Group	Value	95% CI
Treatment	20.7	± 12.6

Night Time Phase 3

Group	Value	95% CI
Treatment	22.0	± 12.6

Overall ST

Group	Value	95% CI
Treatment	38.5	± 18.1

Overall Phase 2

Group	Value	95% CI
Treatment	27.3	± 10.5

Percent of Time ≥ 250 mg/dL Secondary · Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 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	14.7	± 12.9

Day Time Phase 2

Group	Value	95% CI
Treatment	8.4	± 6.3

Night Time ST

Group	Value	95% CI
Treatment	13.2	± 14.0

Night Time Phase 2

Group	Value	95% CI
Treatment	5.1	± 6.2

Overall ST

Group	Value	95% CI
Treatment	14.3	± 12.5

Overall Phase 2

Group	Value	95% CI
Treatment	7.6	± 5.8

Day Time Phase 3

Group	Value	95% CI
Treatment	9.8	± 7.4

Night Time Phase 3

Group	Value	95% CI
Treatment	6.1	± 6.1

Adverse events — posted to ClinicalTrials.gov

Time frame: Start of phase 2 (13 weeks) until the end of phase 3 (12 months).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Phase 2

Serious: 6/240 (3%)

Deaths: 0/240

Phase 3

Serious: 19/224 (8%)

Deaths: 1/224

Serious adverse events (5 terms)

Reaction	System	Phase 2	Phase 3
Other	Investigations	—	—
Severe Hypoglycemia	Endocrine disorders	—	—
Diabetic Ketoacidosis	Endocrine disorders	—	—
Hypoglycemia	Endocrine disorders	—	—
Prolonged Hyperglycemia	Endocrine disorders	—	—

Other adverse events (4 terms — click to expand)

Reaction	System	Phase 2	Phase 3
Other	Investigations	—	—
Prolonged Hyperglycemia	Endocrine disorders	—	—
Hyperglycemia	Endocrine disorders	—	—
Hypoglycemia	Endocrine disorders	—	—

Most-reported serious reactions: Other, Severe Hypoglycemia, Diabetic Ketoacidosis, Hypoglycemia, Prolonged Hyperglycemia.

Data from ClinicalTrials.gov NCT04196140 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

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

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.
   Brown SA, Forlenza GP, Bode BW, Pinsker JE, et al · · 2021 · cited 208× · PMID 34099518 · DOI 10.2337/dc21-0172
2. First Outpatient Evaluation of a Tubeless Automated Insulin Delivery System with Customizable Glucose Targets in Children and Adults with Type 1 Diabetes.
   Forlenza GP, Buckingham BA, Brown SA, Bode BW, et al · · 2021 · cited 52× · PMID 33325779 · DOI 10.1089/dia.2020.0546
3. How introduction of automated insulin delivery systems may influence psychosocial outcomes in adults with type 1 diabetes: Findings from the first investigation with the Omnipod® 5 System.
   Polonsky WH, Hood KK, Levy CJ, MacLeish SA, et al · · 2022 · cited 45× · PMID 35853530 · DOI 10.1016/j.diabres.2022.109998
4. Two Years with a Tubeless Automated Insulin Delivery System: A Single-Arm Multicenter Trial in Children, Adolescents, and Adults with Type 1 Diabetes.
   Criego AB, Carlson AL, Brown SA, Forlenza GP, et al · · 2024 · cited 26× · PMID 37850941 · DOI 10.1089/dia.2023.0364
5. New and Emerging Technologies in Type 1 Diabetes.
   Sherwood JS, Russell SJ, Putman MS. · · 2020 · cited 24× · PMID 33153673 · DOI 10.1016/j.ecl.2020.07.006
6. Review of the Omnipod^® 5 Automated Glucose Control System Powered by Horizon™ for the treatment of Type 1 diabetes.
   Cobry EC, Berget C, Messer LH, Forlenza GP. · · 2020 · cited 23× · PMID 32723002 · DOI 10.4155/tde-2020-0055
7. Therapeutics for type-2 diabetes mellitus: a glance at the recent inclusions and novel agents under development for use in clinical practice.
   Shah N, Abdalla MA, Deshmukh H, Sathyapalan T. · · 2021 · cited 17× · PMID 34589201 · DOI 10.1177/20420188211042145
8. 57^th EASD Annual Meeting of the European Association for the Study of Diabetes.
   · 2021 · cited 11× · PMID 34468792 · DOI 10.1007/s00125-021-05519-y