Can Glucose Monitoring Improve (CGMi Study)

Joslin Diabetes Center

Status

Completed

Conditions

Type 1 Diabetes

Treatments

Behavioral: CGM Family Teamwork Intervention

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01472159

2010-28

R01DK089349 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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 care management. Additionally, there can be difficulties with calibration, skin irritation, frequent skips, excessive or nuisance alarms and inaccurate readings which often lead to diminished use or discontinuation entirely. The purpose of this protocol is to implement and evaluate a family-focused behavioral teamwork intervention aimed at overcoming barriers to sustained CGM use in youth with T1D. In this 2-year RCT, we will assess the long-term acceptability and durability of CGM use and its associated glycemic and psychological outcomes in youth with T1D and their families. We will randomize 120 families to one of two groups: (1) CGM implemented according to usual care (CGM-Usual Care, CGM-UC) or (2) CGM implemented with a family teamwork intervention (CGM-Teamwork, CGM-TW). This intervention will allow participants and families to overcome barriers to sustained CGM use and achieve glycemic benefits that have been afforded to adults using CGM as demonstrated in other research. In year 1, all CGM supplies will be provided and covered by study resources. In year 2, study participants will be asked to cover the costs associated with sensor use and any costs associated with replacement of CGM components in a manner consistent with routine clinical care as the investigators believe that it is important to assess durability of CGM use in clinical practice.

Enrollment

130 patients

Sex

All

Ages

8 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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