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| Name | Class |
|---|---|
| The Leona M. and Harry B. Helmsley Charitable Trust | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CGM | Active Comparator |
| |
| BGM | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Glucose Monitor (CGM) | 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. |
Inclusion Criteria:
Exclusion Criteria:
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
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
Started on non-insulin medication for blood glucose control within the past 3 months or plans to begin within the next 6 months
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.
More than 1 episode of DKA in the past 6 months as defined in the adverse events chapter.
The presence of any of the following diseases:
Inpatient psychiatric treatment in the past 6 months or daily intensive outpatient psychiatric day treatment in the past 3 months.
Pregnant (positive test confirmed at screening) or planning to become pregnant in the next 12 months.
Need for use of acetaminophen or acetaminophen-containing products on a regular basis during the 6 months of the trial
Participation in a diabetes related intervention study in the past 6 weeks.
Any medical, psychological or social situation where per investigator discretion it may be difficult for participant to participate fully in the intervention
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | United States | ||
| Stanford University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40303270 | Derived | 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; 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. | |
| 32543683 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 9, 2018 |
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| Palo Alto |
| California |
| 94304 |
| United States |
| Barbara Davis Center--University of Colorado | Aurora | Colorado | 80045 | United States |
| Yale University | New Haven | Connecticut | 06511 | United States |
| Rocky Mountain Diabetes & Osteoporosis Center | Idaho Falls | Idaho | 83404 | United States |
| Joslin Diabetes Center | Boston | Massachusetts | 02215 | United States |
| IDC at Park Nicollet | Saint Louis Park | Minnesota | 55416 | United States |
| Children's Mercy Hospital | Kansas City | Missouri | 64111 | United States |
| Naomi Berrie Diabetes Center at Columbia University | New York | New York | 10032 | United States |
| SUNY Upstate Medical University | Syracuse | New York | 13210 | United States |
| University of North Carolina | Chapel Hill | North Carolina | 27713 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Vanderbilt University | Nashville | Tennessee | 37212 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| Derived |
| 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. |
| Aug 12, 2020 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 9, 2018 | Feb 22, 2019 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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