Pilot Study of the GlucoWatch G2 Biographer for the Management of Type 1 Diabetes in Children

Completed · Phase 4

Conditions studied: Diabetes Mellitus, Insulin-Dependent

In brief

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.

Key facts

Study ID

NCT00069615

Run by

Jaeb Center for Health Research

People needed

15

Starts

2003-02-01

Expected to finish

2003-06-01

Last updated by the study team

2016-09-05

Who can join

Age: 7 and older, up to 17. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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