NCT00069615

Brief Summary

Devices such as the GlucoWatch G2 Biographer (GW2B), which constantly measure blood sugar levels, may improve the treatment of Type 1 diabetes mellitus in children. This study evaluated the GW2B when used by children in their homes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2003

Shorter than P25 for phase_4

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2003

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2003

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 30, 2003

Completed
Last Updated

September 5, 2016

Status Verified

September 1, 2016

First QC Date

September 29, 2003

Last Update Submit

September 2, 2016

Conditions

Diabetes Mellitus, Insulin-Dependent

Keywords

Diabetes Mellitus, Insulin-DependentType 1 DiabetesContinuous Glucose Monitoring DevicesElectronic Data Collection

Outcome Measures

Primary Outcomes (2)

  • Feasibility of using the GlucoWatch G2 Biographer

  • Feasibility of collecting data from home computers

Interventions

GlucoWatch® G2™ Biographer (GW2B)DEVICE
Continuous Glucose Monitoring System™ (CGMS)DEVICE

Eligibility Criteria

Age7 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Diagnosis of Type 1 diabetes
  • Duration of diabetes \> 1 year
  • Daily insulin therapy (pump or at least 2 injections/day)
  • Stable insulin regimen; not expected to change administration modality within the next 3 months (e.g., injection user switching to pump)

You may not qualify if:

  • The presence of skin abnormalities or a significant medical disorder that in the judgment of the investigator will affect the wearing of the sensors or the completion of any aspect of the protocol.
  • Prior use of a GWB prescribed for home use (Prior use of a GWB as part of a research study is allowable)
  • The presence of any of the following diseases:
  • Asthma if treated with systemic or inhaled corticosteroids in the last 6 months
  • Cystic fibrosis
  • Other major illness that in the judgment of the investigator might interfere with the completion of the protocol
  • Adequately treated thyroid disease and celiac disease do not exclude
  • Inpatient psychiatric treatment in the past 6 months for either the subject or the subject's primary care giver (i.e., parent or guardian).
  • Current use of oral/inhaled glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Division of Pediatric Endocrinology and Diabetes, Stanford University

Stanford, California, 94305-5208, United States

Location

Barbara Davis Center for Childhood Diabetes, University of Colorado

Denver, Colorado, 80262, United States

Location

Department of Pediatrics, Yale University School of Medicine

New Haven, Connecticut, 06519, United States

Location

Nemours Children's Clinic

Jacksonville, Florida, 32207, United States

Location

Jaeb Center for Health Research

Tampa, Florida, 33647, United States

Location

Department of Pediatrics, University of Iowa Carver College of Medicine

Iowa City, Iowa, 52242, United States

Location

Related Publications (2)

  • Stuart Weinzimer, Katrina Ruedy, Jennifer Fisher, Linda Larson, Jennifer Block, Elizabeth Boland, Keisha Bird, and the Diabetes Research in Children Network (DirecNet) Study Group: Diabetes Research in Children Network (DirecNet) Outpatient Pilot Study to Evaluate the GlucoWatch G2 Biographer (GW2B) in the Management of Type 1 Diabetes (T1DM) in Children. Diabetes Technol Ther 2004; 6(2):280.

    BACKGROUND

  • Stuart Weinzimer, Katrina Ruedy, Linda Larson, Jennifer Block, Jennifer Fisher, Elizabeth Doyle, Keisha Bird, and the Diabetes Research in Children Network (DirecNet) Study Group: Diabetes Research in Children Network (DirecNet) Outpatient Pilot Study to Evaluate the Feasibility of Computer-Based Data Acquisition and Transmission. Pediatr Res 2004; 55 (4 Pt 2):138A.

    BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineMonitoring, PhysiologicInvestigative Techniques

Study Officials

  • William V Tamborlane, MD

    Yale University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2003

First Posted

September 30, 2003

Study Start

February 1, 2003

Study Completion

June 1, 2003

Last Updated

September 5, 2016

Record last verified: 2016-09

Locations

US(6)