Continuous Glucose Monitoring System (CGM)-Informed Bolus Calculator Study
Primary Purpose
Type 1 Diabetes
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 focused on measuring T1D, Omnipod
Eligibility Criteria
Inclusion Criteria:
- Age at time of consent/assent 2-70 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
- Must be a current Omnipod user, or have used an Omnipod in the past
- Investigator has confidence that the subject, parent, or legal guardian, can successfully operate all study devices and can adhere to the protocol
- Willing to use only the following types of Insulin during the study: Humalog, Novolog, Admelog, or Apidra
- Must be willing to use the Omnipod Horizon™ in Manual Mode only and agree not to use Automated Mode functionality
- Must be willing to use the Omnipod Horizon™ bolus calculator without a connected CGM for the first 7-days of Manual Mode (Phase 1) while manually entering BG values to deliver boluses
- Must be willing to use the Omnipod Horizon™ bolus calculator with a connected CGM for the last 7-days of Manual Mode (Phase 2) using the CGM-informed bolus calculator to deliver boluses
- Willing to wear the system continuously throughout the study
- For subjects not currently enrolled in the Omnipod Horizon™ Pivotal Study (G190270), A1C <10%
- Must be willing to use the Dexcom App on the Omnipod Horizon™ PDM as the sole source of Dexcom data (except for the Dexcom Follow App)
- Able to read and speak English fluently (if subject is a young child then Caregiver must meet the criteria)
- 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 subjects aged < 18 years per State requirements.
- For subjects aged 2-5.9 years of age, parents or trained caregivers agree to be physically present during the decision and delivery of insulin boluses for this age group, as well as agree to be available for glucose monitoring and treatment during the 4-hour post bolus period.
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 or infusion set failure
- Plans to receive blood transfusion over the course of the study
- Currently diagnosed with anorexia nervosa or bulimia
- Acute or chronic kidney disease 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 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 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
- Clinical signs of hypothyroidism and 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)
- Currently participating or plans to participate in another clinical study using an investigational drug or device other than Omnipod Horizon™. Subjects may be recruited from the Omnipod Horizon Pivotal Study (G190270) prior to their recommencement of the pivotal study after study pause.
- 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
- Sansum Diabetes Research Institute
- University of Colorado Denver
- Atlanta Diabetes
- University of Virginia
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single
Arm Description
All subjects using the Omnipod Horizon™ Automated Glucose Control System in Manual Mode without a connected CGM for 7 days and with a connected CGM for 7 days.
Outcomes
Primary Outcome Measures
Percent of time <70 mg/dL
Glucose metric from continuous glucose monitoring system (CGM)
Percent of time >180 mg/dL
Glucose metric from continuous glucose monitoring system (CGM)
Secondary Outcome Measures
Mean glucose
Glucose metric from continuous glucose monitoring system (CGM)
Percent of time <54 mg/dL
Glucose metric from continuous glucose monitoring system (CGM)
Percent of time ≥ 250 mg/dL
Glucose metric from continuous glucose monitoring system (CGM)
Percent of time ≥ 300 mg/dL
Glucose metric from continuous glucose monitoring system (CGM)
Percent of time in range 70-180 mg/dL
Glucose metric from continuous glucose monitoring system (CGM)
Mean glucose
Glucose metric from continuous glucose monitoring system (CGM)
Percent of time <54 mg/dL
Glucose metric from continuous glucose monitoring system (CGM)
Percent of time <70 mg/dL
Glucose metric from continuous glucose monitoring system (CGM)
Percent of time >180 mg/dL
Glucose metric from continuous glucose monitoring system (CGM)
Percent of time ≥ 250 mg/dL
Glucose metric from continuous glucose monitoring system (CGM)
Percent of time ≥ 300 mg/dL
Glucose metric from continuous glucose monitoring system (CGM)
Percent of time in range 70-180 mg/dL
Glucose metric from continuous glucose monitoring system (CGM)
Percent of time in range 70-140 mg/dL
Glucose metric from 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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04320069
Brief Title
Continuous Glucose Monitoring System (CGM)-Informed Bolus Calculator Study
Official Title
Evaluating the Safety and Effectiveness of the Omnipod Horizon™ CGM-informed Bolus Calculator in Patients With Type 1 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
June 9, 2020 (Actual)
Primary Completion Date
September 29, 2020 (Actual)
Study Completion Date
September 29, 2020 (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 use the Omnipod Horizon™ System in Manual Mode in an outpatient setting for 14-days. Subjects will be trained to use the Manual Mode feature of the Omnipod Horizon™ System including how to use the bolus calculator using manual entry of blood glucose values or by using the CGM-informed bolus calculator.
Detailed Description
The study schedule consists of two outpatient phases:
7 days of Omnipod Horizon™ use in Manual Mode without a connected CGM using manual entry of BG values to deliver boluses (Phase 1) followed by;
7 days of Omnipod Horizon™ use in Manual Mode with a connected CGM using the CGM-informed bolus calculator to deliver boluses (Phase 2)
Following subject screening, system training and enrollment, subjects will commence the first 7-day Manual Mode phase of the study.
Subjects will be trained to use the Manual Mode feature of the system including how to use the bolus calculator using manual entry of BG values or by using the CGM-informed bolus calculator.
After completion of the first 7 days of the Manual Mode phase using the Omnipod Horizon™ without a connected CGM, subjects will transition to the next 7 days of the Manual Mode phase using the system with a connected CGM using the CGM-informed bolus calculator to deliver boluses.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
T1D, Omnipod
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is a single-arm, multi-center, prospective clinical study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single
Arm Type
Experimental
Arm Description
All subjects using the Omnipod Horizon™ Automated Glucose Control System in Manual Mode without a connected CGM for 7 days and with a connected CGM for 7 days.
Intervention Type
Device
Intervention Name(s)
Omnipod Horizon™ Automated Glucose Control System
Intervention Description
Omnipod Horizon™ Automated Glucose Control System use in Manual Mode
Primary Outcome Measure Information:
Title
Percent of time <70 mg/dL
Description
Glucose metric from continuous glucose monitoring system (CGM)
Time Frame
Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period)
Title
Percent of time >180 mg/dL
Description
Glucose metric from continuous glucose monitoring system (CGM)
Time Frame
Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period)
Secondary Outcome Measure Information:
Title
Mean glucose
Description
Glucose metric from continuous glucose monitoring system (CGM)
Time Frame
Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period)
Title
Percent of time <54 mg/dL
Description
Glucose metric from continuous glucose monitoring system (CGM)
Time Frame
Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period)
Title
Percent of time ≥ 250 mg/dL
Description
Glucose metric from continuous glucose monitoring system (CGM)
Time Frame
Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period)
Title
Percent of time ≥ 300 mg/dL
Description
Glucose metric from continuous glucose monitoring system (CGM)
Time Frame
Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period)
Title
Percent of time in range 70-180 mg/dL
Description
Glucose metric from continuous glucose monitoring system (CGM)
Time Frame
Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period)
Title
Mean glucose
Description
Glucose metric from continuous glucose monitoring system (CGM)
Time Frame
Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall
Title
Percent of time <54 mg/dL
Description
Glucose metric from continuous glucose monitoring system (CGM)
Time Frame
Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall
Title
Percent of time <70 mg/dL
Description
Glucose metric from continuous glucose monitoring system (CGM)
Time Frame
Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall
Title
Percent of time >180 mg/dL
Description
Glucose metric from continuous glucose monitoring system (CGM)
Time Frame
Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall
Title
Percent of time ≥ 250 mg/dL
Description
Glucose metric from continuous glucose monitoring system (CGM)
Time Frame
Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall
Title
Percent of time ≥ 300 mg/dL
Description
Glucose metric from continuous glucose monitoring system (CGM)
Time Frame
Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall
Title
Percent of time in range 70-180 mg/dL
Description
Glucose metric from continuous glucose monitoring system (CGM)
Time Frame
Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall
Title
Percent of time in range 70-140 mg/dL
Description
Glucose metric from continuous glucose monitoring system (CGM)
Time Frame
Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), 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 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), 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 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age at time of consent/assent 2-70 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
Must be a current Omnipod user, or have used an Omnipod in the past
Investigator has confidence that the subject, parent, or legal guardian, can successfully operate all study devices and can adhere to the protocol
Willing to use only the following types of Insulin during the study: Humalog, Novolog, Admelog, or Apidra
Must be willing to use the Omnipod Horizon™ in Manual Mode only and agree not to use Automated Mode functionality
Must be willing to use the Omnipod Horizon™ bolus calculator without a connected CGM for the first 7-days of Manual Mode (Phase 1) while manually entering BG values to deliver boluses
Must be willing to use the Omnipod Horizon™ bolus calculator with a connected CGM for the last 7-days of Manual Mode (Phase 2) using the CGM-informed bolus calculator to deliver boluses
Willing to wear the system continuously throughout the study
For subjects not currently enrolled in the Omnipod Horizon™ Pivotal Study (G190270), A1C <10%
Must be willing to use the Dexcom App on the Omnipod Horizon™ PDM as the sole source of Dexcom data (except for the Dexcom Follow App)
Able to read and speak English fluently (if subject is a young child then Caregiver must meet the criteria)
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 subjects aged < 18 years per State requirements.
For subjects aged 2-5.9 years of age, parents or trained caregivers agree to be physically present during the decision and delivery of insulin boluses for this age group, as well as agree to be available for glucose monitoring and treatment during the 4-hour post bolus period.
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 or infusion set failure
Plans to receive blood transfusion over the course of the study
Currently diagnosed with anorexia nervosa or bulimia
Acute or chronic kidney disease 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 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 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
Clinical signs of hypothyroidism and 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)
Currently participating or plans to participate in another clinical study using an investigational drug or device other than Omnipod Horizon™. Subjects may be recruited from the Omnipod Horizon Pivotal Study (G190270) prior to their recommencement of the pivotal study after study pause.
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
Jordan Pinsker, MD
Organizational Affiliation
Sansum Diabetes Research Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Sansum Diabetes Research Institute
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Facility Name
University of Colorado Denver
City
Denver
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Atlanta Diabetes
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30318
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
34491825
Citation
Pinsker JE, Church MM, Brown SA, Voelmle MK, Bode BW, Narron B, Huyett LM, Lee JB, O'Connor J, Benjamin E, Dumais B, Ly TT. Clinical Evaluation of a Novel CGM-Informed Bolus Calculator with Automatic Glucose Trend Adjustment. Diabetes Technol Ther. 2022 Jan;24(1):18-25. doi: 10.1089/dia.2021.0140. Epub 2021 Sep 3.
Results Reference
derived
Learn more about this trial
Continuous Glucose Monitoring System (CGM)-Informed Bolus Calculator Study
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