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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

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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Device: Continuous Glucose Monitor (CGM) Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 25, 2018
Estimated Primary Completion Date : May 6, 2019
Estimated Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Active Comparator: CGM 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.

No Intervention: BGM



Primary Outcome Measures :
  1. Change in HbA1c from baseline to 26 weeks adjusted for baseline [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. % with HbA1c <7.0% [ Time Frame: 6 months ]
  2. % with HbA1c <7.5% [ Time Frame: 6 months ]
  3. % with relative reduction ≥ 10% [ Time Frame: 6 months ]
  4. % with absolute reduction ≥ 0.5% [ Time Frame: 6 months ]
  5. % with absolute reduction ≥ 1% [ Time Frame: 6 months ]
  6. % with absolute reduction ≥ 1% or HbA1c < 7.0% [ Time Frame: 6 months ]
  7. CGM % time in range 70-180 mg/dl [ Time Frame: 6 months ]
  8. CGM mean glucose [ Time Frame: 6 months ]
  9. CGM glucose variability measured by coefficient of variation [ Time Frame: 6 months ]
  10. CGM % time > 180 mg/dl [ Time Frame: 6 months ]
  11. CGM % time > 300 mg/dl [ Time Frame: 6 months ]
  12. CGM % time < 54 mg/dl [ Time Frame: 6 months ]
  13. CGM % time < 70 mg/dl [ Time Frame: 6 months ]
  14. Rate of CGM measured hypoglycemic episodes (using <54 mg/dL) [ Time Frame: 6 months ]
  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03263494


Locations
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United States, California
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
Stanford University
Palo Alto, California, United States, 94304
United States, Colorado
Barbara Davis Center--University of Colorado
Aurora, Colorado, United States, 80045
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06511
United States, Idaho
Rocky Mountain Diabetes & Osteoporosis Center
Idaho Falls, Idaho, United States, 83404
United States, Massachusetts
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215
United States, Minnesota
IDC at Park Nicollet
Saint Louis Park, Minnesota, United States, 55416
United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64111
United States, New York
Naomi Berrie Diabetes Center at Columbia University
New York, New York, United States, 10032
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27713
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37212
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Jaeb Center for Health Research
The Leona M. and Harry B. Helmsley Charitable Trust
  Study Documents (Full-Text)

Documents provided by Jaeb Center for Health Research:
Informed Consent Form  [PDF] April 9, 2018


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Responsible Party: Jaeb Center for Health Research
ClinicalTrials.gov Identifier: NCT03263494     History of Changes
Other Study ID Numbers: CITY
First Posted: August 28, 2017    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019
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: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases