Type 1 Diabetes Clinical Trial
Official title:
Optimizing CGM Use and Metabolic Outcomes in Youth With Type 1 Diabetes
Verified date | August 2021 |
Source | Joslin Diabetes Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 130 |
Est. completion date | August 2015 |
Est. primary completion date | May 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 8 Years to 17 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Joslin Diabetes Center | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Joslin Diabetes Center | Jaeb Center for Health Research, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
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: 10.1177/1932296816676 — View 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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in glycemic control, assessed by hemoglobin A1c | Baseline and 1 year | ||
Secondary | 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 | ||
Secondary | Change in glycemic control, assessed by hemoglobin A1c | Durability of the intervention will be assessed by change in A1c from 1 year to 2 years | 1 year and 2 years | |
Secondary | 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 |
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