Back to resultsOmnipod Horizon™ Automated Glucose Control System Preschool Cohort
Primary Purpose
Type 1 Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Omnipod Horizon™ Automated Glucose Control System
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring T1D, Omnipod
Eligibility Criteria
Inclusion Criteria:
- Age at time of consent 2.0-5.9 years
- Living with parent/legal guardian
- Diagnosed with type 1 diabetes. 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 and/or parent/guardian/caregiver 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
- Willing to wear the system continuously throughout the study
- Willing to participate in challenges for 2 consecutive days, consisting of a minimum of 3 hours of activity per day and dietary challenge by reducing the number of carbohydrates entered for a given meal by 50%
- A1C <10% at screening visit
- Subject and/or parent/guardian must be willing to use the Dexcom App on the Omnipod Horizon™ PDM as the sole source of Dexcom data (with the exception of the Dexcom Follow App) during the hybrid closed-loop phase
- Subject and/or parent/guardian is able to read and speak English fluently
- Has a parent/legal guardian willing and able to sign the ICF.
Exclusion Criteria:
- 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
- Clinical evidence of 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)
- Thyroid Stimulating Hormone (TSH) is outside of normal range with clinical signs of hypothyroidism or hyperthyroidism
- Currently participating or plans to participate in another clinical study using an investigational drug or device other than the Omnipod Horizon™ Automated Glucose Control System during this 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
Sites / Locations
- Stanford University
- University of Colorado Denver
- Yale University School of Medicine
- Atlanta Diabetes
- Joslin Diabetes Center
- International Diabetes Center
- SUNY Syracuse
- University Hospitals Cleveland
- Baylor College of Medicine
- University of Virginia
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm Description
All subjects wearing the Omnipod Horizon™ Automated Glucose Control System using the closed-loop algorithm.
Outcomes
Primary Outcome Measures
Incidence rate of severe hypoglycemia (events per person months)
Measure of serious device-related adverse events
Incidence rate of diabetic ketoacidosis (DKA) (events per person months)
Measure of serious device-related adverse events
Glycated hemoglobin (A1C)
Measures device effectiveness
Time in range 70-180 mg/dL
Measures device effectiveness
Secondary Outcome Measures
Glycated hemoglobin (A1C)
Measures device effectiveness
Percent of time in range 70-180 mg/dL
Glucose metric from study continuous glucose monitoring system (CGM)
Percent of time in range 70-140 mg/dL
Glucose metric from study continuous glucose monitoring system (CGM)
Percent of time > 180 mg/dL
Glucose metric from study continuous glucose monitoring system (CGM)
Percent of time ≥ 250 mg/dL
Glucose metric from study continuous glucose monitoring system (CGM)
Percent of time ≥ 300 mg/dL
Glucose metric from study continuous glucose monitoring system (CGM)
Percent of time < 70 mg/dL
Glucose metric from study continuous glucose monitoring system (CGM)
Percent of time < 54 mg/dL
Glucose metric from study continuous glucose monitoring system (CGM)
Mean glucose
Glucose metric from study continuous glucose monitoring system (CGM)
Standard deviation
Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the standard deviation (SD)
Coefficient of variation
Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the coefficient of variation (CV)
Percentage of time in hybrid closed-loop as proportion of overall device usage time
Measure of system usage
Glucose management indicator (GMI) based on overall mean glucose
Measurement of glucose management using overall glucose averages
Total daily insulin (TDI) (units)
Measure of insulin requirements
Total daily insulin (TDI) (units/kg)
Measure of insulin requirements
Total daily basal insulin (units)
Measure of insulin requirements
Total daily basal insulin (units/kg)
Measure of insulin requirements
Total daily bolus insulin (units)
Measure of insulin requirements
Total daily bolus insulin (units/kg)
Measure of insulin requirements
Body Mass Index (BMI) (kg/m2)
Measure of change in weight
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04476472
Brief Title
Omnipod Horizon™ Automated Glucose Control System Preschool Cohort
Official Title
Evaluating the Safety and Effectiveness of the Omnipod Horizon™ Automated Glucose Control System in Children With Type 1 Diabetes Aged 2.0-5.9 Years: Preschool Cohort
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
September 8, 2020 (Actual)
Primary Completion Date
January 17, 2022 (Actual)
Study Completion Date
October 12, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insulet Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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 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, 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.
During the hybrid closed-loop phase, a subset of subjects will participate in 2-days of supervised meal and exercise challenges.
The hybrid closed-loop phase will begin on Study Day 1.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
T1D, Omnipod
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
single-arm, multi-center, prospective clinical study
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
All subjects wearing the Omnipod Horizon™ Automated Glucose Control System using the closed-loop algorithm.
Intervention Type
Device
Intervention Name(s)
Omnipod Horizon™ Automated Glucose Control System
Intervention Description
The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery.
Primary Outcome Measure Information:
Title
Incidence rate of severe hypoglycemia (events per person months)
Description
Measure of serious device-related adverse events
Time Frame
Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days)
Title
Incidence rate of diabetic ketoacidosis (DKA) (events per person months)
Description
Measure of serious device-related adverse events
Time Frame
Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days)
Title
Glycated hemoglobin (A1C)
Description
Measures device effectiveness
Time Frame
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
Title
Time in range 70-180 mg/dL
Description
Measures device effectiveness
Time Frame
Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days)
Secondary Outcome Measure Information:
Title
Glycated hemoglobin (A1C)
Description
Measures device effectiveness
Time Frame
Hybrid closed-loop (94 days, 180 days, 270 days, and 450 days) compared to baseline
Title
Percent of time in range 70-180 mg/dL
Description
Glucose metric from study continuous glucose monitoring system (CGM)
Time Frame
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
Title
Percent of time in range 70-140 mg/dL
Description
Glucose metric from study continuous glucose monitoring system (CGM)
Time Frame
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
Title
Percent of time > 180 mg/dL
Description
Glucose metric from study continuous glucose monitoring system (CGM)
Time Frame
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
Title
Percent of time ≥ 250 mg/dL
Description
Glucose metric from study continuous glucose monitoring system (CGM)
Time Frame
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
Title
Percent of time ≥ 300 mg/dL
Description
Glucose metric from study continuous glucose monitoring system (CGM)
Time Frame
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
Title
Percent of time < 70 mg/dL
Description
Glucose metric from study continuous glucose monitoring system (CGM)
Time Frame
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
Title
Percent of time < 54 mg/dL
Description
Glucose metric from study continuous glucose monitoring system (CGM)
Time Frame
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
Title
Mean glucose
Description
Glucose metric from study continuous glucose monitoring system (CGM)
Time Frame
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
Title
Standard deviation
Description
Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the standard deviation (SD)
Time Frame
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
Title
Coefficient of variation
Description
Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the coefficient of variation (CV)
Time Frame
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
Title
Percentage of time in hybrid closed-loop as proportion of overall device usage time
Description
Measure of system usage
Time Frame
Phase 2 hybrid closed-loop (94 days) and Phase 3 (450 days)
Title
Glucose management indicator (GMI) based on overall mean glucose
Description
Measurement of glucose management using overall glucose averages
Time Frame
Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days)
Title
Total daily insulin (TDI) (units)
Description
Measure of insulin requirements
Time Frame
Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days)
Title
Total daily insulin (TDI) (units/kg)
Description
Measure of insulin requirements
Time Frame
Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days)
Title
Total daily basal insulin (units)
Description
Measure of insulin requirements
Time Frame
Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days)
Title
Total daily basal insulin (units/kg)
Description
Measure of insulin requirements
Time Frame
Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days)
Title
Total daily bolus insulin (units)
Description
Measure of insulin requirements
Time Frame
Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days)
Title
Total daily bolus insulin (units/kg)
Description
Measure of insulin requirements
Time Frame
Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days)
Title
Body Mass Index (BMI) (kg/m2)
Description
Measure of change in weight
Time Frame
Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age at time of consent 2.0-5.9 years
Living with parent/legal guardian
Diagnosed with type 1 diabetes. 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 and/or parent/guardian/caregiver 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
Willing to wear the system continuously throughout the study
Willing to participate in challenges for 2 consecutive days, consisting of a minimum of 3 hours of activity per day and dietary challenge by reducing the number of carbohydrates entered for a given meal by 50%
A1C <10% at screening visit
Subject and/or parent/guardian must be willing to use the Dexcom App on the Omnipod Horizon™ PDM as the sole source of Dexcom data (with the exception of the Dexcom Follow App) during the hybrid closed-loop phase
Subject and/or parent/guardian is able to read and speak English fluently
Has a parent/legal guardian willing and able to sign the ICF.
Exclusion Criteria:
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
Clinical evidence of 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)
Thyroid Stimulating Hormone (TSH) is outside of normal range with clinical signs of hypothyroidism or hyperthyroidism
Currently participating or plans to participate in another clinical study using an investigational drug or device other than the Omnipod Horizon™ Automated Glucose Control System during this 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce Buckingham, MD
Organizational Affiliation
Stanford School of Medicine
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sue Brown, MD
Organizational Affiliation
University of Virginia
Official's Role
Study Chair
Facility Information:
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
University of Colorado Denver
City
Denver
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
Atlanta Diabetes
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30318
Country
United States
Facility Name
Joslin Diabetes Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
International Diabetes Center
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
SUNY Syracuse
City
Syracuse
State/Province
New York
ZIP/Postal Code
13244
Country
United States
Facility Name
University Hospitals Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22904
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35678724
Citation
Sherr JL, Bode BW, Forlenza GP, Laffel LM, Schoelwer MJ, Buckingham BA, Criego AB, DeSalvo DJ, MacLeish SA, Hansen DW, Ly TT; Omnipod 5 in Preschoolers Study Group:; Sherr JL, Weyman K, Tichy E, VanName M, Brei M, Zgorski M, Steffen A, Carria L, Bode BW, Busby A, Forlenza GP, Wadwa RP, Slover R, Cobry E, Messer L, Laffel LM, Isganaitis E, Ambler-Osborn L, Freiner E, Turcotte C, Volkening L, Schoelwer M, Brown SA, Krauthause K, Emory E, Oliveri M, Buckingham BA, Ekhlaspour L, Kingman R, Criego AB, Schwartz BL, Gandrud LM, Grieme A, Hyatt J, DeSalvo DJ, McKay S, DeLaO K, Villegas C, MacLeish SA, Wood JR, Kaminski BA, Casey T, Campbell W, Behm K, Adams R, Hansen DW, Stone SL, Bzdick S, Bulger J, Agostini L, Doolittle S, Kivilaid K, Kleve K, Ly TT, Dumais B, Vienneau T, Huyett LM, Lee JB, O'Connor J, Benjamin E. 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. Diabetes Care. 2022 Aug 1;45(8):1907-1910. doi: 10.2337/dc21-2359.
Results Reference
derived
Learn more about this trial
Omnipod Horizon™ Automated Glucose Control System Preschool Cohort
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