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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

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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Device: Omnipod Horizon™ Automated Glucose Control System Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
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
Official Title: Evaluating the Safety and Effectiveness of the Omnipod Horizon™ CGM-informed Bolus Calculator in Patients With Type 1 Diabetes
Actual Study Start Date : June 9, 2020
Actual Primary Completion Date : June 30, 2020
Actual Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
Drug Information available for: Dextrose

Arm Intervention/treatment
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.
Device: Omnipod Horizon™ Automated Glucose Control System
Omnipod Horizon™ Automated Glucose Control System use in Manual Mode




Primary Outcome Measures :
  1. 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)

  2. 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)


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. 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)

  11. 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)

  12. 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)

  13. 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)

  14. 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)

  15. 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04320069


Locations
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United States, California
Sansum Diabetes Research Institute
Santa Barbara, California, United States, 93105
United States, Colorado
University of Colorado Denver
Denver, Colorado, United States, 80045
United States, Georgia
Atlanta Diabetes
Atlanta, Georgia, United States, 30318
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22904
Sponsors and Collaborators
Insulet Corporation
Investigators
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Study Chair: Jordan Pinsker, MD Sansum Diabetes Research Institute
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Responsible Party: Insulet Corporation
ClinicalTrials.gov Identifier: NCT04320069    
Other Study ID Numbers: G200018
First Posted: March 24, 2020    Key Record Dates
Last Update Posted: July 14, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Insulet Corporation:
T1D
Omnipod
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases