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Diabetes Control and Complications Trial (DCCT)

Diabetes Control and Complications Trial (DCCT). Results indicate that most youth with T1DM should be treated intensively in order to reduce the risk of progression of retinopathy and the development of microalbuminuria. The Problem.

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Diabetes Control and Complications Trial (DCCT)

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  1. Diabetes Control and Complications Trial (DCCT) Results indicate that most youth with T1DM should be treated intensively in order to reduce the risk of progression of retinopathy and the development of microalbuminuria.

  2. The Problem Translation of DCCT recommendations for treatment of youth with T1DM was expected to be especially challenging, since adolescents in that study had both higher HbA1c levels and an increased risk for severe hypoglycemia compared to adults.

  3. The introduction of continuous glucose monitoring systems has provided pediatric practitioners with new tools to meet the special challenges presented by treatment of T1DM in children and adolescents. One of the Solutions?

  4. The Diabetes Research in Children Network was developed to test the clinical utility of continuous glucose monitoring in children with T1DM. DirecNet

  5. Creation of DirecNet • Cooperative agreement through National Institute of Child Health and Human Development (NICHD) and National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) • RFA released February 22, 2001 • 5-year research grants awarded August 2001

  6. Centers in DirecNet • Coordinating Center • Jaeb Center for Health Research, Tampa, FL • Clinical Centers • University of Colorado: Denver, CO • Children’s Hospital of Iowa: Iowa City, IA • Nemours Children’s Clinic: Jacksonville, FL • Stanford University: Stanford, CA • Yale University: New Haven, CT

  7. NIH Clinical Steering Coordinating Centers Committee Center Chairman Organizational Structure

  8. Steering Committee DSMB Project Management Protocol Development Oversight Organizational Structure

  9. DirecNet’s Vision To develop standard study protocols and the research infrastructure to test clinically important questions regarding use of currently approved devices and new glucose monitoring systems, as they come online, in children with T1DM.

  10. Inpatient Accuracy Study Principal Aim: To assess the accuracy of the Medtronic MiniMed CGMS and the GlucoWatch Biographer II vs gold standard plasma glucose measurements in children with T1DM Lead Investigator: Bruce Buckingham, M.D., Stanford

  11. Study Design Subjects: 90 patients with T1DM in 3 age groups • 1-6 yrs • 7-11 yrs • 12-17yrs 26 hr CRC admission • 1-2 CGMS • 1-2 GWB II • Gold Standard plasma glucose via IV catheter

  12. Daily Glucose Variations • Procedure • Regular meals and insulin doses • GS glucose q30-60 min

  13. Meal Induced Hyperglycemia Test • Procedure • 75 g liquid CHO meal • Delayed pre-meal bolus • GS glucose q 5min x 60 min

  14. Insulin Induced Hypoglycemia Test • Procedure • IV Insulin 0.05-0.1 units/kg • Oral or IV glucose given if plasma glucose <60mg/dl • GS glucose q 5min

  15. Progress to Date • 73 patients have completed study • Recruitment to be completed in November • First manuscript to be completed by February, 2003

  16. Other DirecNet Inpatient Studies In Progress: • CGMS and GWB II performance and 26hr GS glucose levels in healthy, non-diabetic children aged 7-17 yrs Future Studies: • Use of this protocol to test new devices as they become available

  17. DirecNet Outpatient Study(Protocol in Development) Lead Investigator: Peter Chase, M.D. U of Colorado Design: • Randomized Clinical Trial • 200 children with T1DM aged 7-17 yrs • Experimental Group: SMBG + Sensor • Control Group: SMBG • Outcomes: A1c, hypoglycemia, psychosocial • Innovative electronic data capture

  18. Personal Note We have assembled an outstanding group of centers and will develop a portfolio of research protocols that will allow rapid translation of advances in glucose sensor technology to the management of children and adolescents with diabetes.

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