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

NCT ID: NCT03263494

Last Updated: 2020-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 153 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-25
• Study Completion Date: 2019-11-07

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.

Conditions

Type 1 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CGM

Group Type: ACTIVE_COMPARATOR

Continuous Glucose Monitor (CGM)

Intervention Type: DEVICE

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.

BGM

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Leona M. and Harry B. Helmsley Charitable Trust

OTHER

Sponsor Role: collaborator

Jaeb Center for Health Research

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Children's Hospital Los Angeles

Los Angeles, California, United States

Stanford University

Palo Alto, California, United States

Barbara Davis Center--University of Colorado

Aurora, Colorado, United States

Yale University

New Haven, Connecticut, United States

Rocky Mountain Diabetes & Osteoporosis Center

Idaho Falls, Idaho, United States

Joslin Diabetes Center

Boston, Massachusetts, United States

IDC at Park Nicollet

Saint Louis Park, Minnesota, United States

Children's Mercy Hospital

Kansas City, Missouri, United States

Naomi Berrie Diabetes Center at Columbia University

New York, New York, United States

SUNY Upstate Medical University

Syracuse, New York, United States

University of North Carolina

Chapel Hill, North Carolina, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Vanderbilt University

Nashville, Tennessee, United States

Baylor College of Medicine

Houston, Texas, United States

Countries

United States

References

Miller KM, Bauza C, Kanapka LG, Clements MA, DeSalvo DJ, Hood K, Messer LH, Sherr J, Bergamo K, Criego A, Freiner E, Lyons SK, Monzavi R, Moore W, Prahalad P, Simmons JH, Sulik M, Wadwa RP, Weinstock RS, Willi SM, Williams K, Laffel LM; for the CITY Study Group. Continuous Glucose Monitoring Provides Durable Glycemic Benefit in Adolescents and Young Adults with Type 1 Diabetes: 12-Month Follow-Up Results. Pediatr Diabetes. 2023 Oct 26;2023:6718115. doi: 10.1155/2023/6718115. eCollection 2023.

Reference Type: DERIVED

PMID: 40303270 (View on PubMed)

Laffel LM, Kanapka LG, Beck RW, Bergamo K, Clements MA, Criego A, DeSalvo DJ, Goland R, Hood K, Liljenquist D, Messer LH, Monzavi R, Mouse TJ, Prahalad P, Sherr J, Simmons JH, Wadwa RP, Weinstock RS, Willi SM, Miller KM; CGM Intervention in Teens and Young Adults with T1D (CITY) Study Group; CDE10. Effect of Continuous Glucose Monitoring on Glycemic Control in Adolescents and Young Adults With Type 1 Diabetes: A Randomized Clinical Trial. JAMA. 2020 Jun 16;323(23):2388-2396. doi: 10.1001/jama.2020.6940.

Reference Type: DERIVED

PMID: 32543683 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

CITY

Identifier Type: -

Identifier Source: org_study_id