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

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

Study Description

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Locations

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

More Information

• Responsible Party: Jaeb Center for Health Research
• ClinicalTrials.gov Identifier: NCT03263494 History of Changes
• Other Study ID Numbers: CITY
• First Posted: August 28, 2017
• Last Update Posted: February 26, 2019
• Last Verified: February 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

Diabetes Mellitus; Diabetes Mellitus, Type 1; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases