Assessing Continuous Glucose Monitors in Healthy Children

NCT ID: NCT00069602

Last Updated: 2016-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-08-31
• Study Completion Date: 2002-11-30

Brief 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.

Detailed 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.

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Continuous Glucose Monitoring System (CGMS)

Intervention Type: DEVICE

GlucoWatch G2TM Biographer (GW2B)

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

NIH

Sponsor Role: collaborator

Jaeb Center for Health Research

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William V. Tamborlane, MD

Role: STUDY_CHAIR

Yale University

Locations

Division of Pediatric Endocrinology and Diabetes, Stanford University

Stanford, California, United States

Barbara Davis Center for Childhood Diabetes, University of Colorado

Denver, Colorado, United States

Department of Pediatrics, Yale University School of Medicine

New Haven, Connecticut, United States

Nemours Children's Clinic

Jacksonville, Florida, United States

Jaeb Center for Health Research

Tampa, Florida, United States

Department of Pediatrics, University of Iowa Carver College of Medicine

Iowa City, Iowa, United States

Countries

United States

References

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

Reference Type: BACKGROUND

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

Reference Type: BACKGROUND

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

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

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. doi: 10.1016/j.jpeds.2004.03.042.

Reference Type: BACKGROUND

PMID: 15192625 (View on PubMed)

Other Identifiers

HD041890

Identifier Type: -

Identifier Source: secondary_id

HD041919-01

Identifier Type: -

Identifier Source: secondary_id

HD041908-01

Identifier Type: -

Identifier Source: secondary_id

HD041906-01

Identifier Type: -

Identifier Source: secondary_id

HD041918-01

Identifier Type: -

Identifier Source: secondary_id

HD041915

Identifier Type: -

Identifier Source: secondary_id

DirecNet 002

Identifier Type: -

Identifier Source: org_study_id