Type 1 Diabetes MellitusNCT04196140

Pivotal Omnipod Horizon™ Automated Glucose Control System

A study of Type 1 Diabetes Mellitus, run by Insulet Corporation at 16 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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. Read more about this study

Who is it for?: Ages 6 to 70 years
Conditions the study is for: Type 1 Diabetes Mellitus
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 240 participants
Where: 16 sitesUnited States
Study dates: 30 Dec 2019to 20 Apr 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 to 70 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Age at time of consent/assent 6-70 years
Subjects aged < 18 years must be living with parent/legal guardian
Diagnosed with type 1 diabetes for at least 6 months. Diagnosis is based on investigator's clinical judgment
Deemed appropriate for pump therapy per investigator's assessment taking into account previous history of severe hypoglycemic and hyperglycemic events, and other comorbidities
Investigator has confidence that the subject can successfully operate all study devices and is capable of adhering to the protocol
Willing to use only the following types of insulin during the study: Humalog, Novolog, Admelog or Apidra during the study

Show all 13Show fewer

Must be willing to travel to and participate in meal and exercise challenges during 5-days of the hybrid closed-loop phase
Willing to wear the system continuously throughout the study
A1C <10% at screening visit
Must be willing to use the Dexcom App on the Omnipod Horizon™ Personal Diabetes Manager (PDM) as the sole source of Dexcom data (with the exception of the Dexcom Follow App) during the hybrid closed-loop phase
Subjects scoring ≥ 4 on the Clarke Questionnaire must agree to have an overnight companion, defined as someone who resides in the same home or building as the study subject and who can be available overnight
Able to read and speak English fluently
Willing and able to sign the Informed Consent Form (ICF) and/or has a parent/guardian willing and able to sign the ICF. Assent will be obtained from pediatric and adolescent subjects aged < 18 years per State requirements.

Who cannot join

A medical condition, which in the opinion of the investigator, would put the subject at an unacceptable safety risk
History of severe hypoglycemia in the past 6 months
History of DKA in the past 6 months, unrelated to an intercurrent illness, infusion set failure or initial diagnosis
Diagnosed with sickle cell disease
Diagnosed with hemophilia or any other bleeding disorders
Plans to receive blood transfusion over the course of the study

Show all 19Show fewer

Currently diagnosed with anorexia nervosa or bulimia
Acute or chronic kidney disease (e.g. estimated GFR < 45) or currently on hemodialysis
History of adrenal insufficiency
Has taken oral or injectable steroids within the past 8-weeks or plans to take oral or injectable steroids during the course of the study
Unable to tolerate adhesive tape or has any unresolved skin condition in the area of sensor or pump placement
Plans to use insulin other than U-100 insulin intended for use in the study device during the course of the study
Use of non-insulin anti-diabetic medication other than metformin (e.g. GLP1 agonist, SGLT2 inhibitor, DPP-4 inhibitor, pramlintide)
Current or known history of coronary artery disease that is not stable with medical management, including unstable angina, or angina that prevents moderate exercise despite medical management, or a history of myocardial infarction, percutaneous coronary intervention, or coronary artery bypass grafting within the previous 12-months.
For subjects >50 years old or with diabetes duration >20 years, abnormal electrocardiogram consistent with increased risk of arrhythmia, ischemia, or prolonged QTc interval (> 450 ms)
Thyroid Stimulating Hormone (TSH) is outside of normal range with clinical signs of hypothyroidism or hyperthyroidism
Pregnant or lactating, or is a woman of childbearing potential and not on acceptable form of birth control (acceptable includes abstinence, condoms, oral/injectable contraceptives, IUD or implant)
Participation in another clinical study using an investigational drug or device other than the Omnipod Horizon™ Automated Glucose Control System within the preceding 30-days or intends to participate during the study period
Unable to follow clinical protocol for the duration of the study or is otherwise deemed unacceptable to participate in the study per the investigator's clinical judgment

Trial locations and contacts

16 sites in 1 country.

City, postcode or hospital

16 sites in 1 country

United States16 sites

Atlanta Diabetes
Atlanta, Georgia, 30318
Joslin Diabetes Center
Boston, Massachusetts, 02215
University of Virginia
Charlottesville, Virginia, 22904
University Hospitals Cleveland
Cleveland, Ohio, 44106
University of Colorado Denver
Denver, Colorado, 80045
Northwestern University
Evanston, Illinois, 60208
Baylor College of Medicine
Houston, Texas, 77030
East Coast Institute for Research
Macon, Georgia, 31210
Yale University
New Haven, Connecticut, 06511
Mount Sinai
New York, New York, 10029
Stanford University
Palo Alto, California, 94305
International Diabetes Center
Saint Louis Park, Minnesota, 55416
Sansum Diabetes Research Institute
Santa Barbara, California, 93105
University of Washington
Seattle, Washington, 98109
SUNY Syracuse
Syracuse, New York, 13244
Iowa Diabetes
West Des Moines, Iowa, 50265

Other trials in United States

About this study

Official title: Evaluating the Safety and Effectiveness of the Omnipod Horizon™ Automated Glucose Control System in Patients With Type 1 Diabetes

Read the detailed description

The study schedule will consist of a standard therapy data collection phase followed by a hybrid closed-loop phase.

Subjects will undergo a 14-day outpatient, standard therapy phase (Phase 1 or ST) during which sensor and insulin data will be collected. Subjects, or their caregivers, will manage their diabetes at home per their usual routine using the study continuous glucose monitoring system (CGM) and remain on current multiple daily injections (MDI) or pump therapy. This will be followed by a 94-day (13-week) hybrid closed-loop phase (Phase 2), conducted in an outpatient setting where subjects, or their caregivers, will manage their diabetes at home using the Omnipod Horizon™ Automated Glucose Control System. After completing the 94-day hybrid closed-loop phase, subjects will have the option to continue using the system for an additional 12 months (Phase 3).

During the hybrid closed-loop phase, there will be supervised exercise challenges. A subset of subjects will participate in 5-days of supervised Meal and Exercise challenges. A subset of subjects will participate in 3-days of supervised HypoProtect Exercise challenges where comparisons were made between exercising in Automated Mode vs initiating HypoProtect 60 minutes prior to exercise vs initiating HypoProtect 30 minutes prior to exercise.

The hybrid closed-loop phase will begin on Study Day 1.

Conditions: Type 1 Diabetes Mellitus
Being tested: Omnipod Horizon™ Automated Glucose Control System
Keywords: T1D, Omnipod
Medical subject headings: Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Omnipod Horizon™ Automated Glucose Control SystemDevice
The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery

Study groups in NCT04196140
Study group	Role	What they receive
Treatment	Experimental	All subjects wearing the Omnipod Horizon™ Automated Glucose Control System using the closed-loop algorithm. Receives: Device: Omnipod Horizon™ Automated Glucose Control System

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence Rate of Severe Hypoglycemia (Events Per Person Months)
Measure of serious device-related adverse events
Measured: Phase 2 hybrid closed-loop (94 days)
Incidence Rate of Diabetic Ketoacidosis (DKA) (Events Per Person Months)
Measure of serious device-related adverse events
Measured: Phase 2 hybrid closed-loop (94 days)
Glycated Hemoglobin (A1C)
Measures device effectiveness
Measured: 6 weeks continuous Phase 2 participation compared to baseline
Time in Range 70-180 mg/dL
Measures device effectiveness
Measured: Phase 2 hybrid closed-loop (94 days) compared to Phase 1 standard therapy (14 days)

Secondary outcomes (22)

Percent of Time >180 mg/dL
Glucose metric from study continuous glucose monitoring system (CGM)
Measured: Phase 2 hybrid closed-loop (94 days) compared to Phase 1 standard therapy (14 days)
Percent of Time <70 mg/dL
Glucose metric from study continuous glucose monitoring system (CGM)
Measured: Phase 2 hybrid closed-loop (94 days) compared to Phase 1 standard therapy (14 days)
Glycated Hemoglobin (A1C)
Measures device effectiveness
Measured: 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)
Mean Glucose
Glucose metric from study continuous glucose monitoring system (CGM)
Measured: 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
Percent of Time in Range 70-180 mg/dL
Glucose metric from study continuous glucose monitoring system (CGM)
Measured: 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
Percent of Time in Range 70-140 mg/dL
Glucose metric from study continuous glucose monitoring system (CGM)
Measured: 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
Percent of Time >180 mg/dL
Glucose metric from study continuous glucose monitoring system (CGM)
Measured: 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
Percent of Time ≥ 250 mg/dL
Glucose metric from study continuous glucose monitoring system (CGM)
Measured: 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
Percent of Time ≥ 300 mg/dL
Glucose metric from study continuous glucose monitoring system (CGM)
Measured: 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
Percent of Time < 70 mg/dL
Glucose metric from study continuous glucose monitoring system (CGM)
Measured: 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
Percent of Time < 54 mg/dL
Glucose metric from study continuous glucose monitoring system (CGM)
Measured: 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
Standard Deviation (of Glucose)
Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the standard deviation (SD)
Measured: 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
Percent Coefficient of Variation (of Glucose)
Glucose metric from study continuous glucose monitoring system (CGM)- measured glucose variability with the coefficient of variation (CV). Calculated by dividing the standard deviation of CGM values by the mean CGM values in the observation period.
Measured: 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
Percentage of Time in Hybrid Closed-loop as Proportion of Overall Device Usage Time
Measure of system usage
Measured: Phase 2 hybrid closed-loop (94 days) and Phase 3 (270 days)
Percent Glucose Management Indicator (% GMI)
Glucose Management Indicator (%) approximates the laboratory hemoglobin A1c (%) expected based on average glucose readings from continuous glucose monitors from the last 14 days or more. Percent GMI provides information to a person with diabetes with how well their glucose is controlled over an extended period of time. A low value is more desirable than a high value, with a value of <7% being ideal for most people with diabetes. The calculation for GMI is as follows: GMI (%) = 3.31 + 0.02392 x (mean glucose reading in mg/dL from the last 14 days or more).
Measured: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 days) compared to the Phase 1 standard therapy (14 days)
Total Daily Insulin (TDI) (Units)
Measure of insulin requirements
Measured: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 days) compared to the Phase 1 standard therapy (14 days)
Total Daily Insulin (TDI) (Units/kg)
Measure of insulin requirements
Measured: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 days) compared to the Phase 1 standard therapy (14 days)
Total Daily Basal Insulin (Units)
Measure of insulin requirements
Measured: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 days) compared to the Phase 1 standard therapy (14 days)
Total Daily Basal Insulin (Units/kg)
Measure of insulin requirements
Measured: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 days) compared to the Phase 1 standard therapy (14 days)
Total Daily Bolus Insulin (Units)
Measure of insulin requirements
Measured: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 days) compared to the Phase 1 standard therapy (14 days)
Total Daily Bolus Insulin (Units/kg)
Measure of insulin requirements
Measured: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 days) compared to the Phase 1 standard therapy (14 days)
Body Mass Index (BMI) (kg/m^2)
Measure of change in weight
Measured: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 days) compared to baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Dec 201920 Apr 2022

First posted12 Dec 2019
Study start30 Dec 2019
Primary completion10 Jul 2020
Study completion20 Apr 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: This is a single-arm, multi-center, prospective clinical study.
Masking: None (open label)
Enrolment: 240 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04196140
Sponsor's protocol ID: Horizon™ Pivotal Study
Status last verified: Apr 2025
First submitted: 5 Dec 2019
Last updated: 3 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Hood KK, Polonsky WH, MacLeish SA, Levy CJ, Forlenza GP, Criego AB, Buckingham BA, Bode BW, Hansen DW, Sherr JL, Brown SA, DeSalvo DJ, Mehta SN, Laffel LM, Bhargava A, Huyett LM, Vienneau TE, Ly TT. Psychosocial Outcomes with the Omnipod(R) 5 Automated Insulin Delivery System in Children and Adolescents with Type 1 Diabetes and Their Caregivers. Pediatr Diabetes. 2023 Jun 29;2023:8867625. doi: 10.1155/2023/8867625. eCollection 2023.
PubMed 40303234
Criego AB, Carlson AL, Brown SA, Forlenza GP, Bode BW, Levy CJ, Hansen DW, Hirsch IB, Bergenstal RM, Sherr JL, Mehta SN, Laffel LM, Shah VN, Bhargava A, Weinstock RS, MacLeish SA, DeSalvo DJ, Jones TC, Aleppo G, Buckingham BA, Ly TT. Two Years with a Tubeless Automated Insulin Delivery System: A Single-Arm Multicenter Trial in Children, Adolescents, and Adults with Type 1 Diabetes. Diabetes Technol Ther. 2024 Jan;26(1):11-23. doi: 10.1089/dia.2023.0364. Epub 2023 Nov 30.
PubMed 37850941
Hughes MS, Kingman RS, Hsu L, Lal RA, Buckingham BA, Zaharieva DP. Swimming With the Omnipod 5 Automated Insulin Delivery System: Connectivity in the Water. Diabetes Care. 2023 Aug 1;46(8):e148-e150. doi: 10.2337/dc23-0470. No abstract available.
PubMed 37311429
Polonsky WH, Hood KK, Levy CJ, MacLeish SA, Hirsch IB, Brown SA, Bode BW, Carlson AL, Shah VN, Weinstock RS, Bhargava A, Jones TC, Aleppo G, Mehta SN, Laffel LM, Forlenza GP, Sherr JL, Huyett LM, Vienneau TE, Ly TT; Omnipod 5 Research Group. 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(R) 5 System. Diabetes Res Clin Pract. 2022 Aug;190:109998. doi: 10.1016/j.diabres.2022.109998. Epub 2022 Jul 16.
PubMed 35853530
Brown SA, Forlenza GP, Bode BW, Pinsker JE, Levy CJ, Criego AB, Hansen DW, Hirsch IB, Carlson AL, Bergenstal RM, Sherr JL, Mehta SN, Laffel LM, Shah VN, Bhargava A, Weinstock RS, MacLeish SA, DeSalvo DJ, Jones TC, Aleppo G, Buckingham BA, Ly TT; Omnipod 5 Research Group. 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 Jul;44(7):1630-1640. doi: 10.2337/dc21-0172. Epub 2021 Jun 7.
PubMed 34099518

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Adapting FAMS to Optimize CGM Use Among Emerging Adults With Type 1 Diabetes
Type 1 Diabetes
Not yet recruiting
Outpatient Pramlintide Study
Type 1 Diabetes
Active, not recruitingPhase 2
Frexalimab in Preservation of Endogenous Insulin Secretion Compared to Placebo in Adults and Adolescents on Top of Insulin Therapy (FABULINUS)
Type 1 Diabetes Mellitus
Active, not recruitingPhase 2
Probiotics in Newly Diagnosed T1D
Type 1 Diabetes, Type1diabetes
Recruiting
Differentiating Heart Disease Between Adult-onset Autoimmune and Type 2 Diabetes
Diabete Mellitus, Autoimmune Diabetes

All Type 1 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluating the Safety and Effectiveness of the Omnipod Horizon™ Automated Glucose Control System in Patients With Type 1 Diabetes
ClinicalTrials.gov ID: NCT04196140
Acronym / sponsor ID: Horizon™ Pivotal Study
Conditions: Type 1 Diabetes Mellitus
Keywords: T1D, Omnipod
Study type: Interventional
Recruitment status: Completed
Enrolment: 240 participants (actual)
Lead sponsor: Insulet CorporationIndustry (pharma, biotech, devices)
Study start: 30 Dec 2019 (actual)
Primary completion: 10 Jul 2020 (actual)
Study completion: 20 Apr 2022 (actual)
First posted: 12 Dec 2019 (actual)
Results: Posted 14 May 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The study schedule will consist of a standard therapy data collection phase followed by a hybrid closed-loop phase.

The hybrid closed-loop phase will begin on Study Day 1.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: This is a single-arm, multi-center, prospective clinical study.

Arm	Type	Receives
Treatment	Experimental	Device: Omnipod Horizon™ Automated Glucose Control SystemAll subjects wearing the Omnipod Horizon™ Automated Glucose Control System using the closed-loop algorithm.

Who may qualify

Ages: 6 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (13 listed)

Age at time of consent/assent 6-70 years
Subjects aged < 18 years must be living with parent/legal guardian
Diagnosed with type 1 diabetes for at least 6 months. Diagnosis is based on investigator's clinical judgment
Deemed appropriate for pump therapy per investigator's assessment taking into account previous history of severe hypoglycemic and hyperglycemic events, and other comorbidities
Investigator has confidence that the subject can successfully operate all study devices and is capable of adhering to the protocol

Key exclusion criteria (19 listed)

A medical condition, which in the opinion of the investigator, would put the subject at an unacceptable safety risk
History of severe hypoglycemia in the past 6 months
History of DKA in the past 6 months, unrelated to an intercurrent illness, infusion set failure or initial diagnosis
Diagnosed with sickle cell disease
Diagnosed with hemophilia or any other bleeding disorders

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Omnipod Horizon™ Automated Glucose Control SystemThe Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery	Device	Treatment

Primary outcome

Incidence Rate of Severe Hypoglycemia (Events Per Person Months)
Time frame: Phase 2 hybrid closed-loop (94 days)
Measure of serious device-related adverse events
Incidence Rate of Diabetic Ketoacidosis (DKA) (Events Per Person Months)
Time frame: Phase 2 hybrid closed-loop (94 days)
Measure of serious device-related adverse events
Glycated Hemoglobin (A1C)
Time frame: 6 weeks continuous Phase 2 participation compared to baseline
Measures device effectiveness
Time in Range 70-180 mg/dL
Time frame: Phase 2 hybrid closed-loop (94 days) compared to Phase 1 standard therapy (14 days)
Measures device effectiveness

22 secondary outcomes

Percent of Time >180 mg/dL
Time frame: Phase 2 hybrid closed-loop (94 days) compared to Phase 1 standard therapy (14 days)
Percent of Time <70 mg/dL
Time frame: Phase 2 hybrid closed-loop (94 days) compared to Phase 1 standard therapy (14 days)
Glycated Hemoglobin (A1C)
Time frame: 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)
Mean Glucose
Time frame: 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
Percent of Time in Range 70-180 mg/dL
Time frame: 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
Percent of Time in Range 70-140 mg/dL
Time frame: 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
Percent of Time >180 mg/dL
Time frame: 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
Percent of Time ≥ 250 mg/dL
Time frame: 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
Percent of Time ≥ 300 mg/dL
Time frame: 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
Percent of Time < 70 mg/dL
Time frame: 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
Percent of Time < 54 mg/dL
Time frame: 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
Standard Deviation (of Glucose)
Time frame: 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
Percent Coefficient of Variation (of Glucose)
Time frame: 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
Percentage of Time in Hybrid Closed-loop as Proportion of Overall Device Usage Time
Time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 (270 days)
Percent Glucose Management Indicator (% GMI)
Time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 days) compared to the Phase 1 standard therapy (14 days)
Total Daily Insulin (TDI) (Units)
Time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 days) compared to the Phase 1 standard therapy (14 days)
Total Daily Insulin (TDI) (Units/kg)
Time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 days) compared to the Phase 1 standard therapy (14 days)
Total Daily Basal Insulin (Units)
Time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 days) compared to the Phase 1 standard therapy (14 days)
Total Daily Basal Insulin (Units/kg)
Time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 days) compared to the Phase 1 standard therapy (14 days)
Total Daily Bolus Insulin (Units)
Time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 days) compared to the Phase 1 standard therapy (14 days)
Total Daily Bolus Insulin (Units/kg)
Time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 days) compared to the Phase 1 standard therapy (14 days)
Body Mass Index (BMI) (kg/m^2)
Time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 days) compared to baseline

Results and safety

Results posted to the registry on 14 May 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment	240	235

Primary outcome: Incidence Rate of Severe Hypoglycemia (Events Per Person Months)

Time frame: Phase 2 hybrid closed-loop (94 days). Number. Unit: events per person month

Measure	Treatment n = 240
Value	.004

Primary outcome: Incidence Rate of Diabetic Ketoacidosis (DKA) (Events Per Person Months)

Time frame: Phase 2 hybrid closed-loop (94 days). Number. Unit: events per person month

Measure	Treatment n = 240
Value	.001

Primary outcome: Glycated Hemoglobin (A1C)

Time frame: 6 weeks continuous Phase 2 participation compared to baseline. Mean (Standard Deviation). Unit: percentage of HbA1C

Measure	Treatment n = 240
Baseline	7.4 (0.9)
Phase 2	6.9 (0.7)

Primary outcome: Time in Range 70-180 mg/dL

Time frame: Phase 2 hybrid closed-loop (94 days) compared to Phase 1 standard therapy (14 days). Mean (Standard Deviation). Unit: % Time in Range

Measure	Treatment n = 240
Day Time ST	58.6 (17.5)
Day Time Phase 2	68.8 (10.7)
Night Time ST	60.1 (19.8)
Night Time Phase 2	78.1 (12.6)
Overall ST	59.0 (17.2)
Overall Phase 2	71.2 (10.2)

22 secondary outcomes are reported in the full results.

Adverse events

Time frame: Start of phase 2 (13 weeks) until the end of phase 3 (12 months).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Phase 2	6 of 240 (2.5%)	36 of 240 (15%)	0 of 240
Phase 3	19 of 224 (8.5%)	107 of 224 (47.8%)	1 of 224

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40303234Hood KK, Polonsky WH, MacLeish SA, Levy CJ, Forlenza GP, Criego AB, Buckingham BA, Bode BW, Hansen DW, Sherr JL, Brown SA, DeSalvo DJ, Mehta SN, Laffel LM, Bhargava A, Huyett LM, Vienneau TE, Ly TT. Psychosocial Outcomes with the Omnipod(R) 5 Automated Insulin Delivery System in Children and Adolescents with Type 1 Diabetes and Their Caregivers. Pediatr Diabetes. 2023 Jun 29;2023:8867625. doi: 10.1155/2023/8867625. eCollection 2023.
Derived from this study: PubMed 37850941Criego AB, Carlson AL, Brown SA, Forlenza GP, Bode BW, Levy CJ, Hansen DW, Hirsch IB, Bergenstal RM, Sherr JL, Mehta SN, Laffel LM, Shah VN, Bhargava A, Weinstock RS, MacLeish SA, DeSalvo DJ, Jones TC, Aleppo G, Buckingham BA, Ly TT. Two Years with a Tubeless Automated Insulin Delivery System: A Single-Arm Multicenter Trial in Children, Adolescents, and Adults with Type 1 Diabetes. Diabetes Technol Ther. 2024 Jan;26(1):11-23. doi: 10.1089/dia.2023.0364. Epub 2023 Nov 30.
Derived from this study: PubMed 37311429Hughes MS, Kingman RS, Hsu L, Lal RA, Buckingham BA, Zaharieva DP. Swimming With the Omnipod 5 Automated Insulin Delivery System: Connectivity in the Water. Diabetes Care. 2023 Aug 1;46(8):e148-e150. doi: 10.2337/dc23-0470. No abstract available.
Derived from this study: PubMed 35853530Polonsky WH, Hood KK, Levy CJ, MacLeish SA, Hirsch IB, Brown SA, Bode BW, Carlson AL, Shah VN, Weinstock RS, Bhargava A, Jones TC, Aleppo G, Mehta SN, Laffel LM, Forlenza GP, Sherr JL, Huyett LM, Vienneau TE, Ly TT; Omnipod 5 Research Group. 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(R) 5 System. Diabetes Res Clin Pract. 2022 Aug;190:109998. doi: 10.1016/j.diabres.2022.109998. Epub 2022 Jul 16.
Derived from this study: PubMed 34099518Brown SA, Forlenza GP, Bode BW, Pinsker JE, Levy CJ, Criego AB, Hansen DW, Hirsch IB, Carlson AL, Bergenstal RM, Sherr JL, Mehta SN, Laffel LM, Shah VN, Bhargava A, Weinstock RS, MacLeish SA, DeSalvo DJ, Jones TC, Aleppo G, Buckingham BA, Ly TT; Omnipod 5 Research Group. 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 Jul;44(7):1630-1640. doi: 10.2337/dc21-0172. Epub 2021 Jun 7.
Individual participant dataSharing planned: No

Related trials for Type 1 Diabetes Mellitus

Active, not recruiting
Adapting FAMS to Optimize CGM Use Among Emerging Adults With Type 1 Diabetes
Type 1 Diabetes
Not yet recruiting
Outpatient Pramlintide Study
Type 1 Diabetes
Active, not recruitingPhase 2
Frexalimab in Preservation of Endogenous Insulin Secretion Compared to Placebo in Adults and Adolescents on Top of Insulin Therapy (FABULINUS)
Type 1 Diabetes Mellitus
Active, not recruitingPhase 2
Probiotics in Newly Diagnosed T1D
Type 1 Diabetes, Type1diabetes
Recruiting
Differentiating Heart Disease Between Adult-onset Autoimmune and Type 2 Diabetes
Diabete Mellitus, Autoimmune Diabetes

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bruce Buckingham, MD study chair

Stanford University

Sue Brown, MD study chair

University of Virginia

16 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study of Type 1 Diabetes Mellitus, run by Insulet Corporation at 16 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence Rate of Severe Hypoglycemia (Events Per Person Months) (time frame: Phase 2 hybrid closed-loop (94 days)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04196140, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.