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NCT Number: NCT00069602

Assessing Continuous Glucose Monitors in Healthy Children

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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Division of Pediatric Endocrinology and Diabetes, Stanford University, Stanford, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continuous Glucose Monitoring System (CGMS)

Device

GlucoWatch G2TM Biographer (GW2B)

Device

Primary outcomes

  1. Accuracy of the GlucoWatch G2 Biographer and CGMS sensors

Sponsors and collaborators

Lead sponsor

Jaeb Center for Health Research

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2002
Study completion
2002
First posted
Sep 30, 2003
Registry last updated
Sep 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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