Status:
COMPLETED
Can Glucose Monitoring Improve (CGMi Study)
Lead Sponsor:
Joslin Diabetes Center
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Jaeb Center for Health Research
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
8-17 years
Phase:
NA
Brief Summary
The purpose of this 2-year randomized controlled trial (RCT) is to implement and evaluate a family-focused behavioral teamwork intervention aimed at overcoming barriers to sustained continuous glucose...
Detailed Description
Consistent CGM use in youth with T1D has been difficult to sustain historically. Youth with T1D and their families have routinely felt burden related to the introduction of this technology into their ...
Eligibility Criteria
Inclusion
- Age 8-17 years
- Planning to be living at home for 2 years
- Type 1 diabetes of at least 1 year duration
- Daily insulin dose ≥0.5 units/kg
- A1c ≥6.5% and ≤10.0%
- Insulin therapy with continuous subcutaneous insulin infusion (CSII) or multiple daily injections (≥3 injections/day)
- Blood glucose (BG) monitoring frequency ≥4 times/day
- Agreement to wear a CGM device
- Fluency in English for child and parent/guardian
- Stable living situation for ≥6 months (e.g., no Department of Youth Services Involvement)
- Joslin Clinic attendance: At least one Joslin Clinic visit in last year AND Anticipated care at Joslin Clinic for duration of study
Exclusion
- Consistent CGM use, defined as 6+ days/week during the previous 6 months
- History of severe, life-threatening skin reactions to the adhesive used with the CGM device
- Pregnancy in the youth participant or intention to become pregnant within the next 2 years
- Significant developmental or cognitive disorder in the youth or parent/guardian that would prevent full participation in a family-based, behavioral intervention or implementation of CGM
- Inpatient psychiatric admission within the previous 6 months
- Participation in another intervention study during the previous 3 months
- Intent to enroll in another intervention study during the study period
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT01472159
Start Date
October 1 2011
End Date
August 1 2015
Last Update
August 10 2021
Active Locations (1)
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1
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215