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

Diabetes Mellitus, Insulin-Dependent Clinical Trial

Official title:

DirecNet Pilot Study to Evaluate the GlucoWatch G2 Biographer in the Management of Type 1 Diabetes in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00069615
• Other study ID #: DirecNet 003
• Secondary ID: HD041890HD041919
• Status: Completed
• Phase: Phase 4
• First received: September 29, 2003
• Last updated: September 2, 2016
• Start date: February 2003
• Est. completion date: June 2003

Study information

• Verified date: September 2016
• Source: Jaeb Center for Health Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 7 Years to 17 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Insulin-Dependent
• Diabetes Mellitus, Type 1

Intervention

Device:
• GlucoWatch® G2™ Biographer (GW2B)

• Continuous Glucose Monitoring System™ (CGMS)

Locations

Country	Name	City	State
United States	Barbara Davis Center for Childhood Diabetes, University of Colorado	Denver	Colorado
United States	Department of Pediatrics, University of Iowa Carver College of Medicine	Iowa City	Iowa
United States	Nemours Children's Clinic	Jacksonville,	Florida
United States	Department of Pediatrics, Yale University School of Medicine	New Haven	Connecticut
United States	Division of Pediatric Endocrinology and Diabetes, Stanford University	Stanford	California
United States	Jaeb Center for Health Research	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Jaeb Center for Health Research	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & 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.

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of using the GlucoWatch G2 Biographer
Primary	Feasibility of collecting data from home computers