Assessing Continuous Glucose Monitors in Healthy Children

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00069602

Enrollment

Registered

2003-09-30

Start date

2002-08-31

Completion date

2002-11-30

Last updated

2016-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

Keywords

Continuous Glucose Monitoring Devices, Blood glucose profiles in normal children, Blood glucose profiles in non-diabetic children

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.

Interventions

DEVICEGlucoWatch G2TM Biographer (GW2B)

DEVICEContinuous Glucose Monitoring System (CGMS)

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

7 Years to 17 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Accuracy of the GlucoWatch G2 Biographer and CGMS sensors	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026