The availability of continuous glucose monitoring (CGM) technologies provides opportunities to achieve target hemoglobin A1c (A1c) levels for persons with type 1 diabetes (T1D). Until there is a fully automated closed- loop insulin delivery system, human motivation and stamina for implementation and sustained use of CGM devices are necessary. The recently published study by the Juvenile Diabetes Research Foundation (JDRF) CGM Study Group demonstrated significant improvements in A1c without an increase in hypoglycemia in adult patients using CGM compared to standard BG monitoring. Young persons with T1D randomized to CGM did not experience the same benefits as adults randomized to CGM. However, pediatric patients who used CGM consistently did experience the same improvements in A1c as adults. Unfortunately, the greatest non- adherence to CGM occurred in 8-17 year olds. In this application, we seek to realize the benefits of CGM for improving metabolic control and reducing severe hypoglycemia in youth ages 8-17 with T1D. In a prospective, randomized, controlled clinical trial, we will assign 120 youth with T1D of duration >=1 year to 1 of 2 groups: (1) CGM implemented according to standard care (CGM-SC) or (2) CGM implemented with a manualized, family- focused teamwork intervention administered using motivational interviewing techniques to overcome recognized barriers to CGM use (CGM-TW). The 2-year clinical trial will provide an opportunity to evaluate longer-term use of CGM and its associated metabolic and behavioral outcomes in pediatric patients with T1D. Completion of this trial will provide previously unavailable data regarding the longer-term efficacy and effectiveness of CGM implemented with and without a family-focused, behavioral teamwork intervention that encourages CGM implementation and sustained use. The overall aim is to improve metabolic control and preserve behavioral health/psychological outcomes in children and adolescents with T1D in this application entitled, "Optimizing CGM Use and Metabolic Outcomes in Youth with Type 1 Diabetes".

Public Health Relevance

Continuous glucose monitoring (CGM) improves glycemic control without increasing hypoglycemia in adults with type 1 diabetes (T1D);youth with T1D do not experience equivalent benefit. This application will design, implement, and evaluate a family-focused behavioral intervention to encourage sustained CGM use in pediatric patients with T1D in order for them to realize the glycemic benefits afforded to adult patients using this technology. The current application will evaluate the long-term acceptability and durability of CGM, and assess the metabolic outcomes and behavioral impact of CGM on pediatric patients with T1D and their families.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project (R01)
Project #
5R01DK089349-04
Application #
8538952
Study Section
Behavioral Medicine, Interventions and Outcomes Study Section (BMIO)
Program Officer
Hunter, Christine
Project Start
2010-09-30
Project End
2014-08-31
Budget Start
2013-09-01
Budget End
2014-08-31
Support Year
4
Fiscal Year
2013
Total Cost
$632,374
Indirect Cost
$218,910
Name
Joslin Diabetes Center
Department
Type
DUNS #
071723084
City
Boston
State
MA
Country
United States
Zip Code
02215
Rasbach, Lisa E; Atkins, Ashley E; Milaszewski, Kerry M et al. (2014) Treatment recommendations following 3-day masked continuous glucose monitoring (CGM) in youth with type 1 diabetes. J Diabetes Sci Technol 8:494-7
Markowitz, Jessica T; Harrington, Kara R; Laffel, Lori M B (2013) Technology to optimize pediatric diabetes management and outcomes. Curr Diab Rep 13:877-85