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

This study has been completed.

First Received: September 29, 2003 Last Updated: September 21, 2005 History of Changes

Sponsor:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:	NCT00069615

Purpose

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.

Condition	Intervention	Phase
Diabetes Mellitus, Insulin-Dependent	Device: GlucoWatch® G2™ Biographer (GW2B) Device: Continuous Glucose Monitoring System™ (CGMS)	Phase IV

Study Type:	Interventional
Study Design:	Educational/Counseling/Training, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	DirecNet Pilot Study to Evaluate the GlucoWatch G2 Biographer in the Management of Type 1 Diabetes in Children

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Type 1

Drug Information available for: Dextrose

U.S. FDA Resources

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:

Feasibility of using the GlucoWatch G2 Biographer
Feasibility of collecting data from home computers

Estimated Enrollment:	15
Study Start Date:	February 2003
Estimated Study Completion Date:	June 2003

Detailed Description:

The proper role of the GW2B in the management of Type 1 diabetes in children has not been determined. As a prelude to a large-scale randomized clinical trial (RCT) to compare the effect on glycemic control, hypoglycemia, and quality of life of using a GW2B versus standard care, the DirecNet Study Group conducted a pilot study to assess the feasibility of the protocol planned for the RCT and to collect data on changes in HbA1c, frequency of hypoglycemia, frequency of skin reactions, and quality of life after using the GW2B for three months.

Fifteen children and adolescents with Type 1 diabetes participated in this study. Each patient was provided with a personal computer for weekly downloading of the GW2B and for completion of questionnaires regarding hypoglycemia and GW2B use. Participants received study telephone calls after 1, 2, and 4 weeks and every 4 weeks thereafter to review their diabetes management. Participants had a follow-up visit at Week 29. The Continuous Glucose Monitoring System was inserted at this visit to assess hypoglycemia over three days. A follow-up visit was performed at Week 30 to measure HbA1c and administer psychosocial questionnaires.

Eligibility

Ages Eligible for Study:	7 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria

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)

Exclusion Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00069615

Locations

United States, California
Division of Pediatric Endocrinology and Diabetes, Stanford University
Stanford, California, United States, 94305-5208
United States, Colorado
Barbara Davis Center for Childhood Diabetes, University of Colorado
Denver, Colorado, United States, 80262
United States, Connecticut
Department of Pediatrics, Yale University School of Medicine
New Haven, Connecticut, United States, 06519
United States, Florida
Jaeb Center for Health Research
Tampa, Florida, United States, 33647
Nemours Children’s Clinic
Jacksonville, Florida, United States, 32207
United States, Iowa
Department of Pediatrics, University of Iowa Carver College of Medicine
Iowa City, Iowa, United States, 52242

Sponsors and Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

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

Investigators

Study Chair:

William V Tamborlane, MD

Yale University

More Information

Publications:

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.

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.

Study ID Numbers:	DirecNet 003, HD041890, HD041919-01, HD041908-01, HD041906-01, HD041918-01, HD041915
Study First Received:	September 29, 2003
Last Updated:	September 21, 2005
ClinicalTrials.gov Identifier:	NCT00069615 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Diabetes Mellitus, Insulin-Dependent
Type 1 Diabetes
Continuous Glucose Monitoring Devices
Electronic Data Collection

Additional relevant MeSH terms:

Autoimmune Diseases
Metabolic Diseases
Immune System Diseases
Diabetes Mellitus, Type 1

Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on November 27, 2009