Assessing Continuous Glucose Monitors in Healthy Children

Diabetes Mellitus Clinical Trial

Official title:

DirecNet Pilot Study to Assess the Accuracy of Continuous Glucose Monitors in Normal Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00069602
• Other study ID #: DirecNet 002
• Secondary ID: HD041890HD041919
• Status: Completed
• Phase: Phase 4
• First received: September 29, 2003
• Last updated: September 2, 2016
• Start date: August 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

Continuous glucose monitors may be useful in the treatment of children with Type 1 diabetes mellitus. The purpose of this study was to determine whether two FDA-approved continuous glucose monitors, the Continuous Glucose Monitoring System (CGMS) and the GlucoWatch G2TM Biographer (GW2B), are sufficiently accurate to use in future studies to characterize glucose levels in children.

Description:

The characterization of glucose levels in healthy children during day and nighttime is critical to the interpretation of glucose levels in diseases such as diabetes. This study was conducted by the DirecNet Study Group to determine whether two FDA-approved continuous glucose monitors are sufficiently accurate.

The study was conducted at five clinical centers and enrolled approximately 20 healthy children (ages 7 to 17 years old) who did not have Type 1 or Type 2 diabetes nor a history of the disease in their immediate families. Each participant was hospitalized for approximately 26 hours to assess the accuracy of the continuous glucose monitors compared with serum glucose determinations.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2002
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 7 Years to 17 Years

Eligibility

Inclusion Criteria

• Weight >= 16.0 kg (35 lbs)

• Body mass index between the 10th to 90th percentile for age and sex

• HbA1c within normal limits

• Hematocrit within normal limits

Exclusion Criteria

• History of diabetes

• History of positive islet cell antibody testing

• Family history of Type 1 or Type 2 diabetes in a sibling or parent

• Medication use of any type in the 7 days prior to study entry

• Skin abnormalities contraindicating device use

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

Intervention

Device:
• Continuous Glucose Monitoring System (CGMS)

• GlucoWatch G2TM Biographer (GW2B)

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 (8)

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.

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

Mauras N, Beck RW, Ruedy KJ, Kollman C, Tamborlane WV, Chase HP, Buckingham BA, Tsalikian E, Weinzimer S, Booth AD, Xing D; Diabetes Research in Children Network (DirecNet) Accuracy Study. Lack of accuracy of continuous glucose sensors in healthy, nondiabetic children: results of the Diabetes Research in Children Network (DirecNet) accuracy study. J Pediatr. 2004 Jun;144(6):770-5. — View Citation

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

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.

Outcome

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