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Continuous Glucose Monitoring System (CGM)-Informed Bolus Calculator Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04320069
Recruitment Status : Completed
First Posted : March 24, 2020
Last Update Posted : July 14, 2020
Sponsor:
Information provided by (Responsible Party):
Insulet Corporation

Tracking Information
First Submitted Date  ICMJE March 19, 2020
First Posted Date  ICMJE March 24, 2020
Last Update Posted Date July 14, 2020
Actual Study Start Date  ICMJE June 9, 2020
Actual Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 11, 2020)
  • Percent of time <70 mg/dL [ Time Frame: Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period) ]
    Glucose metric from continuous glucose monitoring system (CGM)
  • Percent of time >180 mg/dL [ Time Frame: Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period) ]
    Glucose metric from continuous glucose monitoring system (CGM)
Original Primary Outcome Measures  ICMJE
 (submitted: March 23, 2020)
  • Percent of time <70 mg/dL [ Time Frame: Week 1 compared to week 2 (comparing the 4-hour post bolus period) ]
    Glucose metric from continuous glucose monitoring system (CGM)
  • Percent of time >180 mg/dL [ Time Frame: Week 1 compared to week 2 (comparing the 4-hour post bolus period) ]
    Glucose metric from continuous glucose monitoring system (CGM)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2020)
  • Mean glucose [ Time Frame: Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period) ]
    Glucose metric from continuous glucose monitoring system (CGM)
  • Percent of time <54 mg/dL [ Time Frame: Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period) ]
    Glucose metric from continuous glucose monitoring system (CGM)
  • Percent of time ≥ 250 mg/dL [ Time Frame: Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period) ]
    Glucose metric from continuous glucose monitoring system (CGM)
  • Percent of time ≥ 300 mg/dL [ Time Frame: Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period) ]
    Glucose metric from continuous glucose monitoring system (CGM)
  • Percent of time in range 70-180 mg/dL [ Time Frame: Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period) ]
    Glucose metric from continuous glucose monitoring system (CGM)
  • Mean glucose [ Time Frame: Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall ]
    Glucose metric from continuous glucose monitoring system (CGM)
  • Percent of time <54 mg/dL [ Time Frame: Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall ]
    Glucose metric from continuous glucose monitoring system (CGM)
  • Percent of time <70 mg/dL [ Time Frame: Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall ]
    Glucose metric from continuous glucose monitoring system (CGM)
  • Percent of time >180 mg/dL [ Time Frame: Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall ]
    Glucose metric from continuous glucose monitoring system (CGM)
  • Percent of time ≥ 250 mg/dL [ Time Frame: Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall ]
    Glucose metric from continuous glucose monitoring system (CGM)
  • Percent of time ≥ 300 mg/dL [ Time Frame: Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall ]
    Glucose metric from continuous glucose monitoring system (CGM)
  • Percent of time in range 70-180 mg/dL [ Time Frame: Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall ]
    Glucose metric from continuous glucose monitoring system (CGM)
  • Percent of time in range 70-140 mg/dL [ Time Frame: Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall ]
    Glucose metric from continuous glucose monitoring system (CGM)
  • Standard deviation [ Time Frame: Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall ]
    Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the standard deviation (SD)
  • Coefficient of variation [ Time Frame: Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall ]
    Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the coefficient of variation (CV)
Original Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2020)
  • Mean glucose [ Time Frame: Week 1 compared to week 2(comparing the 4-hour post bolus period) ]
    Glucose metric from continuous glucose monitoring system (CGM)
  • Percent of time <54 mg/dL [ Time Frame: Week 1 compared to week 2 (comparing the 4-hour post bolus period) ]
    Glucose metric from continuous glucose monitoring system (CGM)
  • Percent of time ≥ 250 mg/dL [ Time Frame: Week 1 compared to week 2 (comparing the 4-hour post bolus period) ]
    Glucose metric from continuous glucose monitoring system (CGM)
  • Percent of time ≥ 300 mg/dL [ Time Frame: Week 1 compared to week 2 (comparing the 4-hour post bolus period) ]
    Glucose metric from continuous glucose monitoring system (CGM)
  • Percent of time in range 70-180 mg/dL [ Time Frame: Week 1 compared to week 2 (comparing the 4-hour post bolus period) ]
    Glucose metric from continuous glucose monitoring system (CGM)
  • Mean glucose [ Time Frame: Week 1 compared to week 2, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall ]
    Glucose metric from continuous glucose monitoring system (CGM)
  • Percent of time <54 mg/dL [ Time Frame: Week 1 compared to week 2, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall ]
    Glucose metric from continuous glucose monitoring system (CGM)
  • Percent of time <70 mg/dL [ Time Frame: Week 1 compared to week 2, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall ]
    Glucose metric from continuous glucose monitoring system (CGM)
  • Percent of time >180 mg/dL [ Time Frame: Week 1 compared to week 2, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall ]
    Glucose metric from continuous glucose monitoring system (CGM)
  • Percent of time ≥ 250 mg/dL [ Time Frame: Week 1 compared to week 2, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall ]
    Glucose metric from continuous glucose monitoring system (CGM)
  • Percent of time ≥ 300 mg/dL [ Time Frame: Week 1 compared to week 2, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall ]
    Glucose metric from continuous glucose monitoring system (CGM)
  • Percent of time in range 70-180 mg/dL [ Time Frame: Week 1 compared to week 2, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall ]
    Glucose metric from continuous glucose monitoring system (CGM)
  • Percent of time in range 70-140 mg/dL [ Time Frame: Week 1 compared to week 2, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall ]
    Glucose metric from continuous glucose monitoring system (CGM)
  • Standard deviation [ Time Frame: Week 1 compared to week 2, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall ]
    Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the standard deviation (SD)
  • Coefficient of variation [ Time Frame: Week 1 compared to week 2, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall ]
    Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the coefficient of variation (CV)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Continuous Glucose Monitoring System (CGM)-Informed Bolus Calculator Study
Official Title  ICMJE Evaluating the Safety and Effectiveness of the Omnipod Horizon™ CGM-informed Bolus Calculator in Patients With Type 1 Diabetes
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:

  1. 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;
  2. 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
This is a single-arm, multi-center, prospective clinical study.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type 1 Diabetes
Intervention  ICMJE Device: Omnipod Horizon™ Automated Glucose Control System
Omnipod Horizon™ Automated Glucose Control System use in Manual Mode
Study Arms  ICMJE Experimental: Single
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: Device: Omnipod Horizon™ Automated Glucose Control System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 12, 2020)
25
Original Estimated Enrollment  ICMJE
 (submitted: March 23, 2020)
42
Actual Study Completion Date  ICMJE June 30, 2020
Actual Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age at time of consent/assent 2-70 years
  2. Subjects aged < 18 years must be living with parent/legal guardian
  3. Diagnosed with type 1 diabetes for at least 6 months. Diagnosis is based on investigator's clinical judgment
  4. Must be a current Omnipod user, or have used an Omnipod in the past
  5. Investigator has confidence that the subject, parent, or legal guardian, can successfully operate all study devices and can adhere to the protocol
  6. Willing to use only the following types of Insulin during the study: Humalog, Novolog, Admelog, or Apidra
  7. Must be willing to use the Omnipod Horizon™ in Manual Mode only and agree not to use Automated Mode functionality
  8. 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
  9. 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
  10. Willing to wear the system continuously throughout the study
  11. For subjects not currently enrolled in the Omnipod Horizon™ Pivotal Study (G190270), A1C <10%
  12. 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)
  13. Able to read and speak English fluently (if subject is a young child then Caregiver must meet the criteria)
  14. 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.

Exclusion Criteria:

  1. A medical condition, which in the opinion of the investigator, would put the subject at an unacceptable safety risk
  2. History of severe hypoglycemia in the past 6 months
  3. History of DKA in the past 6 months, unrelated to an intercurrent illness or infusion set failure
  4. Plans to receive blood transfusion over the course of the study
  5. Currently diagnosed with anorexia nervosa or bulimia
  6. Acute or chronic kidney disease or currently on hemodialysis
  7. History of adrenal insufficiency
  8. Has taken oral or injectable steroids within the past 8 weeks or plans to take oral or injectable steroids during the study
  9. Unable to tolerate adhesive tape or has any unresolved skin condition in the area of sensor or pump placement
  10. Plans to use insulin other than U-100 insulin intended for use in the study device during the study
  11. Use of non-insulin anti-diabetic medication other than metformin (e.g. GLP1 agonist, SGLT2 inhibitor, DPP-4 inhibitor, pramlintide)
  12. 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
  13. Clinical signs of hypothyroidism and hyperthyroidism
  14. 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)
  15. 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.
  16. 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 70 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04320069
Other Study ID Numbers  ICMJE G200018
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Insulet Corporation
Study Sponsor  ICMJE Insulet Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Jordan Pinsker, MD Sansum Diabetes Research Institute
PRS Account Insulet Corporation
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP