CGM Intervention in Teens and Young Adults With Type 1 Diabetes (T1D)
- Conditions
- Type 1 Diabetes Mellitus
- Interventions
- Device: Continuous Glucose Monitor (CGM)
- Registration Number
- NCT03263494
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 153
- 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
- Age 14-<25 years
- Diabetes duration ≥ 1 year
- Total daily insulin requirement ≥ 0.4 units/kg/day
- HbA1c 7.5% to <11.0% (Point of care device or local lab measured as part of study at screening visit)
- 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
- 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
- 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.
- Participant comprehends written and spoken English
- Participant understands the study protocol and agrees to it (if applicable)
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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
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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
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Started on non-insulin medication for blood glucose control within the past 3 months or plans to begin within the next 6 months
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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.
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More than 1 episode of DKA in the past 6 months as defined in the adverse events chapter.
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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)
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Inpatient psychiatric treatment in the past 6 months or daily intensive outpatient psychiatric day treatment in the past 3 months.
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Pregnant (positive test confirmed at screening) or planning to become pregnant in the next 12 months.
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Need for use of acetaminophen or acetaminophen-containing products on a regular basis during the 6 months of the trial
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Participation in a diabetes related intervention study in the past 6 weeks.
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Any medical, psychological or social situation where per investigator discretion it may be difficult for participant to participate fully in the intervention
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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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CGM Continuous Glucose Monitor (CGM) -
- Primary Outcome Measures
Name Time Method Change in HbA1c from baseline to 26 weeks adjusted for baseline 6 months
- Secondary Outcome Measures
Name Time Method CGM % time in range 70-180 mg/dl 6 months % with HbA1c <7.5% 6 months CGM mean glucose 6 months % with HbA1c <7.0% 6 months % with absolute reduction ≥ 0.5% 6 months % with relative reduction ≥ 10% 6 months % with absolute reduction ≥ 1% 6 months % with absolute reduction ≥ 1% or HbA1c < 7.0% 6 months CGM glucose variability measured by coefficient of variation 6 months CGM % time < 70 mg/dl 6 months CGM % time > 180 mg/dl 6 months CGM % time > 300 mg/dl 6 months CGM % time < 54 mg/dl 6 months CGM Self Efficacy Questionnaire Score 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.
Hypoglycemia Confidence Questionnaire Score 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.
Rate of CGM measured hypoglycemic episodes (using <54 mg/dL) 6 months Problem Areas in Diabetes (PAID) Questionnaire Score 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.
Glucose Monitoring Satisfaction Questionnaire Score 6 months Survey containing 15 questions. Total score ranges from 0-100. A higher total score indicates more satisfaction with their current glucose monitor.
Diabetes Technology Attitudes Questionnaire Score 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.
Pittsburgh Sleep Quality Index 6 months Survey containing 19 questions. Total score ranges from 0-21. A lower score indicates a healthier sleep quality.
Trial Locations
- Locations (14)
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Children's Hospital Los Angeles
🇺🇸Los Angeles, California, United States
University of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
IDC at Park Nicollet
🇺🇸Saint Louis Park, Minnesota, United States
Rocky Mountain Diabetes & Osteoporosis Center
🇺🇸Idaho Falls, Idaho, United States
Joslin Diabetes Center
🇺🇸Boston, Massachusetts, United States
Yale University
🇺🇸New Haven, Connecticut, United States
Children's Mercy Hospital
🇺🇸Kansas City, Missouri, United States
Stanford University
🇺🇸Palo Alto, California, United States
Naomi Berrie Diabetes Center at Columbia University
🇺🇸New York, New York, United States
Barbara Davis Center--University of Colorado
🇺🇸Aurora, Colorado, United States
Vanderbilt University
🇺🇸Nashville, Tennessee, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
SUNY Upstate Medical University
🇺🇸Syracuse, New York, United States