Status:
COMPLETED
CGM Intervention in Teens and Young Adults With Type 1 Diabetes (T1D)
Lead Sponsor:
Jaeb Center for Health Research
Collaborating Sponsors:
The Leona M. and Harry B. Helmsley Charitable Trust
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
14-24 years
Phase:
PHASE3
Brief Summary
Adolescents and young adults with T1D and poor glycemic control (age 14-\< 25 years, T1D duration \>12 months, HbA1c 7.5-\<11.0%, using an insulin pump or MDI)) will be randomly assigned to either CGM...
Eligibility Criteria
Inclusion
- Clinical diagnosis of T1D, with either age of T1D diagnosis \< 10 years of age OR a history of positive T1D related antibodies in the medical record
- Age 14-\<25 years
- Diabetes duration ≥ 1 year
- Total daily insulin requirement ≥ 0.4 units/kg/day
- HbA1c 7.5% to \<11.0% (Point of care device or local lab measured as part of study at screening visit)
- Insulin regimen involves a consistent modality of insulin administration with either use of an insulin pump or at least 3 multiple daily injections of basal and bolus (meal time) analogue insulin. Insulin pump must not have been started within 3 months of consent with no plans to change regimens in the next 6 months
- Perform at least 2 blood glucose meter checks per day from self-report at screening and an average of at least 2 checks per day from meter download during blinded CGM run in
- Blinded CGM must be used a minimum of 200 hours (equivalent to 8.3 days) with an average of 1.8 calibrations per day during the blinded CGM screening period.
- Participant comprehends written and spoken English
- Participant understands the study protocol and agrees to it (if applicable)
Exclusion
- Use of unblinded personal CGM and/or flash CGM, outside of a research study, as part of real-time diabetes management in the last 3 months
- Unable to use CGM device for minimum number of hours during blinded pre-randomization period or skin reaction from adhesive that would preclude participation in the randomized trial
- Started on non-insulin medication for blood glucose control within the past 3 months or plans to begin within the next 6 months
- The presence of a significant medical disorder that in the judgment of the investigator will affect the wearing of the sensors (such as a skin condition), or the completion of any aspect of the protocol.
- More than 1 episode of DKA in the past 6 months as defined in the adverse events chapter.
- The presence of any of the following diseases:
- Asthma or any condition present in the last 6 months where treatment is a systemic or daily inhaled corticosteroid (Intermittent treatment with inhaled corticosteroids does not exclude subjects from enrollment)
- Cystic fibrosis
- Addison's disease (Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment)
- Inpatient psychiatric treatment in the past 6 months or daily intensive outpatient psychiatric day treatment in the past 3 months.
- Pregnant (positive test confirmed at screening) or planning to become pregnant in the next 12 months.
- Need for use of acetaminophen or acetaminophen-containing products on a regular basis during the 6 months of the trial
- Participation in a diabetes related intervention study in the past 6 weeks.
- Any medical, psychological or social situation where per investigator discretion it may be difficult for participant to participate fully in the intervention
- Any condition, per investigator assessment, that could impact reliability of the A1C measurement, such as (but not limited to) hemoglobinopathy, hemolytic anemia, chronic liver disease; chronic GI blood loss, red blood cell transfusion or erythropoietin administration within 3 months prior to screening
Key Trial Info
Start Date :
January 25 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 7 2019
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT03263494
Start Date
January 25 2018
End Date
November 7 2019
Last Update
March 3 2020
Active Locations (14)
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1
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
2
Stanford University
Palo Alto, California, United States, 94304
3
Barbara Davis Center--University of Colorado
Aurora, Colorado, United States, 80045
4
Yale University
New Haven, Connecticut, United States, 06511