Can Glucose Monitoring Improve (CGMi Study)
Optimizing CGM Use and Metabolic Outcomes in Youth With Type 1 Diabetes
2 other identifiers
interventional
130
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 9, 2011
CompletedFirst Posted
Study publicly available on registry
November 16, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedAugust 10, 2021
August 1, 2021
2.6 years
November 9, 2011
August 3, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Change in glycemic control, assessed by hemoglobin A1c
Baseline and 1 year
Secondary Outcomes (3)
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)
Baseline and 1 year
Change in glycemic control, assessed by hemoglobin A1c
1 year and 2 years
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)
1 year and 2 years
Study Arms (2)
CGM-Usual Care
NO INTERVENTION* Routine CGM education
CGM-Teamwork
EXPERIMENTAL* Routine CGM education * CGM Family Teamwork Intervention
Interventions
The family-focused behavioral intervention targets barriers associated with sustained CGM use in youth with type 1 diabetes. During months 1-18, families in the intervention group will participate in the intervention at each study visit for about an additional 30 minutes.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Joslin Diabetes Center
Boston, Massachusetts, 02215, United States
Related Publications (4)
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.
PMID: 29727245RESULTTelo 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.
PMID: 25749206RESULTVolkening 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.
PMID: 27340247RESULTGiani 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.
PMID: 27807014RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lori Laffel, MD, MPH
Joslin Diabetes Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief, Pediatric, Adolescent, & Young Adult Section; Investigator, Genetics & Epidemiology Section
Study Record Dates
First Submitted
November 9, 2011
First Posted
November 16, 2011
Study Start
October 1, 2011
Primary Completion
May 1, 2014
Study Completion
August 1, 2015
Last Updated
August 10, 2021
Record last verified: 2021-08