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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
153
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.
Children's Hospital Los Angeles
Los Angeles, California, United States
Stanford University
Palo Alto, California, United States
Barbara Davis Center--University of Colorado
Change in HbA1c From Baseline to 26 Weeks Adjusted for Baseline
Time frame: 6 months
% 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 ≥ 0.5% 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
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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
...and 4 more locations
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
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.
Time frame: 6 months
Problem Areas in Diabetes (PAID) Questionnaire Score
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.
Time frame: 6 months
Glucose Monitoring Satisfaction Questionnaire Score
Survey containing 15 questions. Total score ranges from 0-100. A higher total score indicates more satisfaction with their current glucose monitor.
Time frame: 6 months
Hypoglycemia Confidence Questionnaire Score
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.
Time frame: 6 months
Diabetes Technology Attitudes Questionnaire Score
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.
Time frame: 6 months
Pittsburgh Sleep Quality Index
Survey containing 19 questions. Total score ranges from 0-21. A lower score indicates a healthier sleep quality.
Time frame: 6 months