(prepared by applicant):
The specific aim of this application is to determine if glucose control can be safely improved in children with type 1 diabetes as a result of using continuous glucose monitoring (CGM). In an initial feasibility trial, accuracy of the two CGM devices will be compared to venous glucose levels in a Pediatric GCRC. Children with and without diabetes will spend 24 hours in the GCRC. This will also help to sort out children with diabetes (1 in 30) who have excessive skin reactions to the GlucoWatch, or who cannot tolerate subcutaneous CGM sensors. The children with diabetes will then be randomized to a feasibility three-month trial of either using the GlucoWatch Biographer or the MiniMed CGMS or serving as a control. Children will be selected for the feasibility and the two-year study who are either using intensive diabetes management or who are committed to moving toward intensive diabetes management. They must be willing to do at least four self-blood glucose monitoring (SBGM) tests each day. They will be randomized to two years of treatment, including six months of using four GlucoWatch Biographers per week (two day/two night), six months of using the MiniMed CGMS, and a six month control period. Primary end points will be change in HbA1c levels and the incidence of hypoglycemia. HbA1c levels will be determined initially and every three months, or at one and three months in the feasibility trial, with a goal of achieving HbA1c values less than seven percent. The incidence of all hypoglycemic events and of severe hypoglycemia will be compared for the three treatment groups in the three-month feasibility and the two-year longer trial. In addition, each person will serve as their own control in the longer trial as they are randomized to each of the three study groups. Secondary end points will be episodes of ketoacidosis, change in BMI, numbers of sensors used, insulin dose, use of an insulin pump, use of carbohydrate counting, number of SBGM tests done per day and changes in Fear of Hypoglycemia and Quality of Life Questionnaires. Quality of Life and Fear of Hypoglycemia Questionnaires will be used to evaluate psychological factors in both the factors in both the feasibility and the two-year trials.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
3U10HD041919-05S1
Application #
7293965
Study Section
Special Emphasis Panel (ZHD1)
Program Officer
Winer, Karen
Project Start
2001-09-30
Project End
2007-08-31
Budget Start
2005-09-01
Budget End
2007-08-31
Support Year
5
Fiscal Year
2006
Total Cost
$224,568
Indirect Cost
Name
University of Colorado Denver
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
041096314
City
Aurora
State
CO
Country
United States
Zip Code
80045
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Diabetes Research in Children Network (DirecNet) Study Group; Tsalikian, Eva; Tamborlane, William et al. (2009) Blunted counterregulatory hormone responses to hypoglycemia in young children and adolescents with well-controlled type 1 diabetes. Diabetes Care 32:1954-9
Diabetes Research in Children Network Study Group; Weinzimer, Stuart; Xing, Dongyuan et al. (2009) Prolonged use of continuous glucose monitors in children with type 1 diabetes on continuous subcutaneous insulin infusion or intensive multiple-daily injection therapy. Pediatr Diabetes 10:91-6
Messer, Laurel; Ruedy, Katrina; Xing, Dongyuan et al. (2009) Educating families on real time continuous glucose monitoring: the DirecNet navigator pilot study experience. Diabetes Educ 35:124-35
Weinzimer, Stuart; Xing, Dongyuan; Tansey, Michael et al. (2008) FreeStyle navigator continuous glucose monitoring system use in children with type 1 diabetes using glargine-based multiple daily dose regimens: results of a pilot trial Diabetes Research in Children Network (DirecNet) Study Group. Diabetes Care 31:525-7
Wilson, Darrell; Chase, H Peter; Kollman, Craig et al. (2008) Low-fat vs. high-fat bedtime snacks in children and adolescents with type 1 diabetes. Pediatr Diabetes 9:320-5
Diabetes Research in Children Network (DirecNet) Study Group (2008) The accuracy of the Guardian RT continuous glucose monitor in children with type 1 diabetes. Diabetes Technol Ther 10:266-72
Diabetes Research in Children Network (DirecNet) Study Group (2008) Adiponectin and catecholamine concentrations during acute exercise in children with type 1 diabetes. Pediatr Diabetes 9:221-7
Diabetes Research in Children Network (DirecNet) Study Group; Wilson, Darrell M; Kollman (2008) Relationship of A1C to glucose concentrations in children with type 1 diabetes: assessments by high-frequency glucose determinations by sensors. Diabetes Care 31:381-5
Diabetes Research In Children Network (DirecNet) Study Group; Buckingham, Bruce; Xing, Dongyuan et al. (2008) Use of the DirecNet Applied Treatment Algorithm (DATA) for diabetes management with a real-time continuous glucose monitor (the FreeStyle Navigator). Pediatr Diabetes 9:142-7

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