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

NCT ID: NCT00069615

Last Updated: 2016-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-02-28
• Study Completion Date: 2003-06-30

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.

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.

Conditions

Diabetes Mellitus, Insulin-Dependent

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Interventions

GlucoWatch® G2™ Biographer (GW2B)

Intervention Type: DEVICE

Continuous Glucose Monitoring System™ (CGMS)

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

NIH

Sponsor Role: collaborator

Jaeb Center for Health Research

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William V Tamborlane, MD

Role: STUDY_CHAIR

Yale University

Locations

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

Countries

United States

References

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.

Reference Type: 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.

Reference Type: BACKGROUND

Other Identifiers

HD041890

Identifier Type: -

Identifier Source: secondary_id

HD041919-01

Identifier Type: -

Identifier Source: secondary_id

HD041908-01

Identifier Type: -

Identifier Source: secondary_id

HD041906-01

Identifier Type: -

Identifier Source: secondary_id

HD041918-01

Identifier Type: -

Identifier Source: secondary_id

HD041915

Identifier Type: -

Identifier Source: secondary_id

DirecNet 003

Identifier Type: -

Identifier Source: org_study_id