Continuous Glucose Monitors for Children With Diabetes Mellitus

Diabetes Mellitus, Insulin-Dependent Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00069537
• Other study ID #: DirecNet 001
• Secondary ID: HD041890HD041919
• Status: Completed
• Phase: Phase 4
• First received: September 29, 2003
• Last updated: September 2, 2016
• Start date: May 2002
• Est. completion date: November 2002

Study information

• Verified date: September 2016
• Source: Jaeb Center for Health Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: November 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 17 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Insulin-Dependent
• Diabetes Mellitus, Type 1

Intervention

Device:
• The GlucoWatch® G2™ Biographer (GW2B)

• The Continuous Glucose Monitoring System (CGMS™)

Locations

Country	Name	City	State
United States	Barbara Davis Center for Childhood Diabetes, University of Colorado	Denver	Colorado
United States	Department of Pediatrics, University of Iowa Carver College of Medicine	Iowa City	Iowa
United States	Nemours Children's Clinic	Jacksonville,	Florida
United States	Department of Pediatrics, Yale University School of Medicine	New Haven	Connecticut
United States	Division of Pediatric Endocrinology and Diabetes, Stanford University	Stanford	California
United States	Jaeb Center for Health Research	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Jaeb Center for Health Research	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (14)

Boland E, Weinzimer S, Beck R, Ruedy K, Kollman C, Buckingham B, Chase P, Tansey M, Mauras N, and the Diabetes Research In Children Network (DirecNet) Study Group. Performance of the Medtronic MiniMed Continuous Glucose Monitoring System (CGMS) in Children with T1DM in the DirecNet Accuracy Study. Diabetes 2003 Jun;52 Suppl 1:A90.

Buckingham B, Beck R, Tamborlane W, Ruedy K, Boland E, Chase P, Wysocki T, Tsalikian E, Wilson D, Mauras N, Weinzimer D, Tansey M, Fiallo-Scharer R, Booth A, Kollman C, and the Diabetes Research In Children Network (DirecNet) Study Group. Diabetes Research in Children Network (DirecNet) Accuracy Study of the Continuous Glucose Monitoring System (CGMS) and GlucoWatch® G2™ Biographer (GWB) in Children with Type 1 Diabetes-A CRC-based Study. Diabetes 2003 Jun;52 Suppl 1:A36.

Buckingham B, Block J, Burdick J, Kalajian A, Kollman C, Choy M, Wilson DM, Chase P; Diabetes Research in Children Network. Response to nocturnal alarms using a real-time glucose sensor. Diabetes Technol Ther. 2005 Jun;7(3):440-7. — View Citation

Diabetes Research In Children Network (Direcnet) Study Group. A multicenter study of the accuracy of the One Touch Ultra home glucose meter in children with type 1 diabetes. Diabetes Technol Ther. 2003;5(6):933-41. — View Citation

Diabetes Research in Children Network (DirecNet) Study Group. Accuracy of the GlucoWatch G2 Biographer and the continuous glucose monitoring system during hypoglycemia: experience of the Diabetes Research in Children Network. Diabetes Care. 2004 Mar;27(3):722-6. — View Citation

Diabetes Research in Children Network (DIRECNET) Study Group. The accuracy of the CGMS in children with type 1 diabetes: results of the diabetes research in children network (DirecNet) accuracy study. Diabetes Technol Ther. 2003;5(5):781-9. — View Citation

Diabetes Research in Children Network (DIRECNET) Study Group. The accuracy of the GlucoWatch G2 biographer in children with type 1 diabetes: results of the diabetes research in children network (DirecNet) accuracy study. Diabetes Technol Ther. 2003;5(5):791-800. — View Citation

Fiallo-Scharer R, Chase P, Beck R, Ruedy K, Booth A, Wysocki T, Boland E, Buckingham B, Tsalikian E, and the Diabetes Research In Children Network (DirecNet) Study Group. Performance of the One Touch Ultra at Different Glucose Levels in Three Age Groups of Children with T1DM in the CRC-DirecNet Accuracy Study. Diabetes 2003 Jun;52 Suppl 1:A562.

Mauras N, Beck R, Ruedy K, Booth A, Weinzimer S, and the Diabetes Research in Children Network (DirecNet) Study Group. The Physiological Variations of Plasma Glucose Concentrations in Healthy, Non-Diabetic Children: Use of Continuous Glucose Sensors. Pediatr Res 2003 Apr;53(4Pt 2):1A-669A

Tsalikian E, Beck R, Ruedy K, Booth A, Tansey M, and the Diabetes Research in Children Network (DirecNet) Study Group. Glycemic Pattern of Insulin Induced Hypoglycemia in Pediatric Subjects with Type 1 Diabetes Mellitus (T1DM): The DirecNet Experience. Pediatr Res 2003 Apr;53(4Pt2):1A-669A

Tsalikian E, Beck RW, Kalajian A, Janz KF, Tansey MJ; Diabetes Research in Children Network (DirecNet) Study Group. Function of the GlucoWatch G2 Biographer during exercise. Diabetes Technol Ther. 2005 Feb;7(1):230. — View Citation

Tsalikian E, Kollman C, Mauras N, Weinzimer S, Buckingham B, Xing D, Beck R, Ruedy K, Tamborlane W, Fiallo-Scharer R; Diabetes Research in Children Network (DirecNet) Study Group. GlucoWatch G2 Biographer alarm reliability during hypoglycemia in children. Diabetes Technol Ther. 2004 Oct;6(5):559-66. — View Citation

Weinzimer S, Beck R, Ruedy K, Booth A, Boland E, and the Diabetes Research in Children Network (DirecNet) Study Group. Mealtime Glycemic Excursions in Pediatric Subjects with Type 1 Diabetes Mellitus (T1DM): The DirecNet Experience.Pediatr Res 2003 Apr;53(4Pt2):1A-669A

Wilson D, Buckingham B, Beck R, Ruedy K, Kollman C, Tsalikian E, Wysocki T, Weinzimer S, Chase P, and the Diabetes Research in Children Network (DirecNet) Study Group. A 5-center CRC-based Study of the Accuracy of the GlucoWatch®G2™ Biographer in Children and Adolescents with Type 1 Diabetes. Diabetes 2003 Jun;52 Suppl 1:A101.

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of the GlucoWatch G2 Biographer and CGMS