Clinical trial NCT01472159: Can Glucose Monitoring Improve (CGMi Study)
Official title: Optimizing CGM Use and Metabolic Outcomes in Youth With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Lead sponsor: Joslin Diabetes Center
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Jaeb Center for Health Research
First posted: 2011-11-16
Enrollment: 130
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in glycemic control, assessed by hemoglobin A1c
timeFrame: Baseline and 1 year
Secondary outcomes:
measure: Change in psychosocial factors (e.g., self-efficacy, fear of hypoglycemia, quality of life, diabetes-specific family conflict, diabetes responsibility sharing, diabetes-specific burden, anxiety, depressive symptoms)
timeFrame: Baseline and 1 year
measure: Change in glycemic control, assessed by hemoglobin A1c
timeFrame: 1 year and 2 years
measure: Change in psychosocial factors (e.g., self-efficacy, fear of hypoglycemia, quality of life, diabetes-specific family conflict, diabetes responsibility sharing, diabetes-specific burden, anxiety, depressive symptoms)
timeFrame: 1 year and 2 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Joslin Diabetes Center
state: Massachusetts
Study officials:
affiliation: Joslin Diabetes Center
name: Lori Laffel, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: McGill DE, Volkening LK, Butler DA, Harrington KR, Katz ML, Laffel LM. Baseline Psychosocial Characteristics Predict Frequency of Continuous Glucose Monitoring in Youth with Type 1 Diabetes. Diabetes Technol Ther. 2018 Jun;20(6):434-439. doi: 10.1089/dia.2018.0037. Epub 2018 May 4.
citation: Telo GH, Volkening LK, Butler DA, Laffel LM. Salient characteristics of youth with type 1 diabetes initiating continuous glucose monitoring. Diabetes Technol Ther. 2015 Jun;17(6):373-8. doi: 10.1089/dia.2014.0290. Epub 2015 Mar 6.
citation: Volkening LK, Gaffney KC, Katz ML, Laffel LM. Recruitment Into a Pediatric Continuous Glucose Monitoring RCT. J Diabetes Sci Technol. 2017 Jan;11(1):100-107. doi: 10.1177/1932296816656208. Epub 2016 Jul 9.
citation: Giani E, Snelgrove R, Volkening LK, Laffel LM. Continuous Glucose Monitoring (CGM) Adherence in Youth With Type 1 Diabetes: Associations With Biomedical and Psychosocial Variables. J Diabetes Sci Technol. 2017 May;11(3):476-483. doi: 10.1177/1932296816676280. Epub 2016 Nov 1.