Can Glucose Monitoring Improve (CGMi Study)

Completed · Not applicable

Conditions studied: Type 1 Diabetes

In brief

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 monitoring (CGM) use in youth with type 1 diabetes (T1D). We hypothesize that CGM implemented with a family-focused, behavioral teamwork intervention will result in sustained CGM use and greater improvement in A1c compared to routine implementation of CGM.

Key facts

Study ID

NCT01472159

Run by

Joslin Diabetes Center

People needed

130

Starts

2011-10-01

Expected to finish

2015-08-01

Last updated by the study team

2021-08-10

Who can join

Age: 8 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Joslin Diabetes Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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