diabetes control and complications trial (dcct) results indicate that most youth with t1dm should be...
TRANSCRIPT
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
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.
One of the Solutions?
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.
DirecNet
The Diabetes Research in Children
Network was developed to test the
clinical utility of continuous glucose
monitoring in children with T1DM.
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
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
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.
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
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
Daily Glucose Variations
40
60
80
100
120
140
160
180
200
220
240
260
280
300
320
340
360
380
400
2:00 PM 3:00 PM 4:00 PM 5:00 PM 6:00 PM 7:00 PM 8:00 PM 9:00 PM 10:00PM
11:00 PM 12:00AM
1:00 AM 2:00 AM 3:00 AM 4:00 AM 5:00 AM 6:00 AM 7:00 AM 8:00 AM 9:00 AM 10:00AM
11:00AM
12:00PM
1:00 PM 2:00 PM
gluc
ose
(mg/
dl)
Procedure•Regular meals and insulin doses•GS glucose q30-60 min
Meal Induced Hyperglycemia Test
100
120
140
160
180
200
220
240
260
280
300
320
340
360
4:55 PM 5:09 PM 5:24 PM 5:38 PM 5:52 PM 6:07 PM 6:21 PM
glu
cose
(m
g/d
l)
Procedure
•75 g liquid CHO meal
•Delayed pre-meal bolus
•GS glucose q 5min x 60 min
Insulin Induced Hypoglycemia Test
40
60
80
100
120
8:24 AM 8:42 AM 9:00 AM 9:18 AM
gluc
ose
(mg/
dl)
Procedure
•IV Insulin 0.05-0.1 units/kg
•Oral or IV glucose given if plasma glucose <60mg/dl
•GS glucose q 5min
Progress to Date
• 73 patients have completed study
• Recruitment to be completed in November
• First manuscript to be completed by February, 2003
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
DirecNet Outpatient Study(Protocol in Development)
Lead Investigator: Peter Chase, M.D. U of ColoradoDesign:• 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