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CGM Intervention in Teens and Young Adults With Type 1 Diabetes (T1D) (CITY)

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ClinicalTrials.gov Identifier: NCT03263494
Recruitment Status : Active, not recruiting
First Posted : August 28, 2017
Last Update Posted : February 26, 2019
Sponsor:
Collaborator:
The Leona M. and Harry B. Helmsley Charitable Trust
Information provided by (Responsible Party):
Jaeb Center for Health Research

Tracking Information
First Submitted Date  ICMJE August 24, 2017
First Posted Date  ICMJE August 28, 2017
Last Update Posted Date February 26, 2019
Actual Study Start Date  ICMJE January 25, 2018
Estimated Primary Completion Date May 6, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 24, 2017)
Change in HbA1c from baseline to 26 weeks adjusted for baseline [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03263494 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2018)
  • % with HbA1c <7.0% [ Time Frame: 6 months ]
  • % with HbA1c <7.5% [ Time Frame: 6 months ]
  • % with relative reduction ≥ 10% [ Time Frame: 6 months ]
  • % with absolute reduction ≥ 0.5% [ Time Frame: 6 months ]
  • % with absolute reduction ≥ 1% [ Time Frame: 6 months ]
  • % with absolute reduction ≥ 1% or HbA1c < 7.0% [ Time Frame: 6 months ]
  • CGM % time in range 70-180 mg/dl [ Time Frame: 6 months ]
  • CGM mean glucose [ Time Frame: 6 months ]
  • CGM glucose variability measured by coefficient of variation [ Time Frame: 6 months ]
  • CGM % time > 180 mg/dl [ Time Frame: 6 months ]
  • CGM % time > 300 mg/dl [ Time Frame: 6 months ]
  • CGM % time < 54 mg/dl [ Time Frame: 6 months ]
  • CGM % time < 70 mg/dl [ Time Frame: 6 months ]
  • Rate of CGM measured hypoglycemic episodes (using <54 mg/dL) [ Time Frame: 6 months ]
  • CGM Self Efficacy Questionnaire Score [ Time Frame: 6 months ]
    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.
  • Problem Areas in Diabetes (PAID) Questionnaire Score [ Time Frame: 6 months ]
    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.
  • Glucose Monitoring Satisfaction Questionnaire Score [ Time Frame: 6 months ]
    Survey containing 15 questions. Total score ranges from 0-100. A higher total score indicates more satisfaction with their current glucose monitor.
  • Hypoglycemia Confidence Questionnaire Score [ Time Frame: 6 months ]
    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.
  • Diabetes Technology Attitudes Questionnaire Score [ Time Frame: 6 months ]
    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.
  • Pittsburgh Sleep Quality Index [ Time Frame: 6 months ]
    Survey containing 19 questions. Total score ranges from 0-21. A lower score indicates a healthier sleep quality.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 24, 2017)
  • % with HbA1c <7.0% [ Time Frame: 6 months ]
  • % with HbA1c <7.5% [ Time Frame: 6 months ]
  • % with relative reduction ≥ 10% [ Time Frame: 6 months ]
  • % with absolute reduction ≥ 0.5% [ Time Frame: 6 months ]
  • % with absolute reduction ≥ 1% [ Time Frame: 6 months ]
  • % with absolute reduction ≥ 1% or HbA1c < 7.0% [ Time Frame: 6 months ]
  • CGM % time in range 70-180 mg/dl [ Time Frame: 6 months ]
  • CGM mean glucose [ Time Frame: 6 months ]
  • CGM glucose variability measured by coefficient of variation [ Time Frame: 6 months ]
  • CGM % time > 180 mg/dl [ Time Frame: 6 months ]
  • CGM % time > 250 mg/dl [ Time Frame: 6 months ]
  • CGM % time > 300 mg/dl [ Time Frame: 6 months ]
  • CGM % time < 54 mg/dl [ Time Frame: 6 months ]
  • CGM % time < 70 mg/dl [ Time Frame: 6 months ]
  • Rate of CGM measured hypoglycemic episodes (using <70 mg/dL) [ Time Frame: 6 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CGM Intervention in Teens and Young Adults With Type 1 Diabetes (T1D)
Official Title  ICMJE 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
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 life measures. The randomized trial will be followed by a 6-month extension study during which the RCT control group will initiate CGM and the RCT CGM group will continue CGM.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type 1 Diabetes Mellitus
Intervention  ICMJE Device: 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.
Study Arms  ICMJE
  • Active Comparator: CGM
    Intervention: Device: Continuous Glucose Monitor (CGM)
  • No Intervention: BGM
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 Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: August 24, 2017)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2019
Estimated Primary Completion Date May 6, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  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)

Exclusion Criteria:

  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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years to 24 Years   (Child, 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 NCT03263494
Other Study ID Numbers  ICMJE CITY
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: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jaeb Center for Health Research
Study Sponsor  ICMJE Jaeb Center for Health Research
Collaborators  ICMJE The Leona M. and Harry B. Helmsley Charitable Trust
Investigators  ICMJE Not Provided
PRS Account Jaeb Center for Health Research
Verification Date February 2019

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