Continuous Glucose Monitors for Children With Diabetes Mellitus

Sponsor

Jaeb Center for Health Research (Other)

Overall Status

Completed

CT.gov ID

NCT00069537

Collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)

Enrollment

Locations

Duration (Months)

Patients Per Site

2.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Good control of blood glucose levels is important in preventing complications from diabetes. This study assessed the accuracy and reliability of two FDA-approved continuous glucose monitors, the Continuous Glucose Monitoring System (CGMS) and the GlucoWatch G2 Biographer (GW2B), in children with type 1 diabetes mellitus (T1DM).

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Insulin-Dependent	Device: The GlucoWatch® G2™ Biographer (GW2B) Device: The Continuous Glucose Monitoring System (CGMS™)	Phase 4

Detailed Description

Intensive control of blood glucose levels has been shown to substantially prevent or delay complications of T1DM in adolescents and adults. The major limitation to implementation of intensive glycemic control is hypoglycemia. Younger children may be at increased risk for hypoglycemia and the risk/benefit ratio of intensive glycemic control may be less favorable in this population. Intensive therapy has not been systematically evaluated in children less than 13 years of age. This study was conducted by the Diabetes Research in Children Network (DirecNet) to assess the accuracy of the CGMS and the GW2B glucose monitors in comparison with standard blood glucose measurements in an inpatient setting.

During 24-hour clinical research center stays at five clinical centers, approximately 90 children and adolescents with T1DM (1 to 17 years of age) wore two FDA-approved continuous glucose monitors, CGMS and GW2B, and had frequent serum glucose determinations during the day and night. To assess glucose monitor function during periods of rising and falling blood glucose, insulin-induced hypoglycemia and meal-induced hyperglycemia tests were also performed.

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

DirecNet Inpatient Study to Test the Accuracy of Continuous Blood Glucose Monitoring Devices in Children With Type 1 Diabetes

Study Start Date :

May 1, 2002

Study Completion Date :

Nov 1, 2002

Outcome Measures

Primary Outcome Measures

Accuracy of the GlucoWatch G2 Biographer and CGMS []

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria

Clinical diagnosis of type 1 diabetes mellitus for at least 1 year prior to study entry
For children over 2 years of age, body mass index between the 5th and 95th percentile for age and gender
Weight >= 12 kg (26.5 lbs) if < 7 years of age and >= 16 kg (35 lbs) if >7 years of age
Normal hematocrit

Exclusion Criteria

Current use of glucocorticoids
Skin or other medical disorders that would affect completion of the study
History of seizures other than those attributable to either hypoglycemia or high fever

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Division of Pediatric Endocrinology and Diabetes, Stanford University	Stanford	California	United States	94305-5208
2	Barbara Davis Center for Childhood Diabetes, University of Colorado	Denver	Colorado	United States	80262
3	Department of Pediatrics, Yale University School of Medicine	New Haven	Connecticut	United States	06519
4	Nemours Children's Clinic	Jacksonville,	Florida	United States	32207
5	Jaeb Center for Health Research	Tampa	Florida	United States	33647
6	Department of Pediatrics, University of Iowa Carver College of Medicine	Iowa City	Iowa	United States	52242