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CGM Intervention in Teens and Young Adults With Type 1 Diabetes (T1D) (CITY) Phase 3 153 Randomized Adolescent

Completed
Clinical Trial NCT03263494 (CITY) was designed to study Treatment for Type 1 Diabetes Mellitus. This was a Phase 3 interventional study that is now completed. The study started on 25 January 2018, with plans to enroll 153 participants. Led by Jaeb Center for Health Research, the expected completion date was 7 November 2019. The latest data from ClinicalTrials.gov was last updated on 3 March 2020.
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 or BGM. Sample size will be 150. The primary outcome assessment will be HbA1c after 6 months. Secondary outcomes will include HbA1c, CGM metrics (control group will wear blinded CGM at 13 and 24 weeks), and quality of l...Show More
Official Title

CGM Intervention in Teens and Young Adults With T1D (CITY): A Randomized Clinical Trial to Assess the Efficacy and Safety of Continuous Glucose Monitoring in Young Adults 14-<25 With Type 1 Diabetes

Conditions
Type 1 Diabetes Mellitus
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • CITY
NCT ID Number
NCT03263494
Start Date (Actual)
2018-01-25
Last Update Posted
2020-03-03
Completion Date (Estimated)
2019-11-07
Enrollment (Estimated)
153
Study Type
Interventional
PHASE
Phase 3
Status
Completed
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Active ComparatorCGM
Continuous Glucose Monitor (CGM)
Participants randomized to the CGM Group will receive a Dexcom CGM device and be instructed on how to utilize the CGM data in real time for diabetes management.
No InterventionBGM
N/A
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Change in HbA1c from baseline to 26 weeks adjusted for baseline
6 months
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
% with HbA1c <7.0%
6 months
% with HbA1c <7.5%
6 months
% with relative reduction ≥ 10%
6 months
% with absolute reduction ≥ 0.5%
6 months
% with absolute reduction ≥ 1%
6 months
% with absolute reduction ≥ 1% or HbA1c < 7.0%
6 months
CGM % time in range 70-180 mg/dl
6 months
CGM mean glucose
6 months
CGM glucose variability measured by coefficient of variation
6 months
CGM % time > 180 mg/dl
6 months
CGM % time > 300 mg/dl
6 months
CGM % time < 54 mg/dl
6 months
CGM % time < 70 mg/dl
6 months
Rate of CGM measured hypoglycemic episodes (using <54 mg/dL)
6 months
CGM Self Efficacy Questionnaire Score
Questionnaire containing 15 questions with possible responses 0-6. Total score is calculated by taking the mean of the non-missing responses. Then multiply by 100 and divide by 6 to put on the scale 0-100. Higher total score indicates higher perceived ability.
6 months
Problem Areas in Diabetes (PAID) Questionnaire Score
Survey containing 20 questions with possible responses 0-5. Total score is calculated by taking the mean of the non-missing items and multiplying by 20 to put on the scale 0-100. A higher total score indicates more of a problem.
6 months
Glucose Monitoring Satisfaction Questionnaire Score
Survey containing 15 questions. Total score ranges from 0-100. A higher total score indicates more satisfaction with their current glucose monitor.
6 months
Hypoglycemia Confidence Questionnaire Score
Survey containing 9 questions with possible responses 0-4. Total score is calculated by taking the mean of non-missing responses and multiplying by 25 to put on the scale 0-100. Higher total score indicates more confidence.
6 months
Diabetes Technology Attitudes Questionnaire Score
Survey containing 5 questions with possible responses 0-4. Total score is calculated by taking the mean of non-missing responses and multiplying by 25 to put on the scale 0-100. Higher total score indicates a more positive attitude towards diabetes technology.
6 months
Pittsburgh Sleep Quality Index
Survey containing 19 questions. Total score ranges from 0-21. A lower score indicates a healthier sleep quality.
6 months
Eligibility Criteria

Eligible Ages
Child, Adult
Minimum Age
14 Years
Eligible Sexes
All
  1. 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
  2. Age 14-<25 years
  3. Diabetes duration ≥ 1 year
  4. Total daily insulin requirement ≥ 0.4 units/kg/day
  5. HbA1c 7.5% to <11.0% (Point of care device or local lab measured as part of study at screening visit)
  6. 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
  7. 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
  8. 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.
  9. Participant comprehends written and spoken English
  10. Participant understands the study protocol and agrees to it (if applicable)

  1. 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

  2. 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

  3. Started on non-insulin medication for blood glucose control within the past 3 months or plans to begin within the next 6 months

  4. 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.

  5. More than 1 episode of DKA in the past 6 months as defined in the adverse events chapter.

  6. 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)

  7. Inpatient psychiatric treatment in the past 6 months or daily intensive outpatient psychiatric day treatment in the past 3 months.

  8. Pregnant (positive test confirmed at screening) or planning to become pregnant in the next 12 months.

  9. Need for use of acetaminophen or acetaminophen-containing products on a regular basis during the 6 months of the trial

  10. Participation in a diabetes related intervention study in the past 6 weeks.

  11. Any medical, psychological or social situation where per investigator discretion it may be difficult for participant to participate fully in the intervention

  12. 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

Jaeb Center for Health Research logoJaeb Center for Health Research
The Leona M. and Harry B. Helmsley Charitable Trust logoThe Leona M. and Harry B. Helmsley Charitable Trust
No contact data.
14 Study Locations in 1 Countries

California

Children's Hospital Los Angeles, Los Angeles, California, 90027, United States
Stanford University, Palo Alto, California, 94304, United States

Colorado

Barbara Davis Center--University of Colorado, Aurora, Colorado, 80045, United States

Connecticut

Yale University, New Haven, Connecticut, 06511, United States

Idaho

Rocky Mountain Diabetes & Osteoporosis Center, Idaho Falls, Idaho, 83404, United States

Massachusetts

Joslin Diabetes Center, Boston, Massachusetts, 02215, United States

Minnesota

IDC at Park Nicollet, Saint Louis Park, Minnesota, 55416, United States

Missouri

Children's Mercy Hospital, Kansas City, Missouri, 64111, United States

New York

Naomi Berrie Diabetes Center at Columbia University, New York, New York, 10032, United States
SUNY Upstate Medical University, Syracuse, New York, 13210, United States

North Carolina

University of North Carolina, Chapel Hill, North Carolina, 27713, United States

Pennsylvania

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, 19104, United States

Tennessee

Vanderbilt University, Nashville, Tennessee, 37212, United States

Texas

Baylor College of Medicine, Houston, Texas, 77030, United States