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

September 2, 2016 updated by: Jaeb Center for Health Research

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

15

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jaeb Center for Health Research

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2003

Study Completion

June 1, 2003

Study Registration Dates

First Submitted

September 29, 2003

First Submitted That Met QC Criteria

September 29, 2003

First Posted (Estimate)

September 30, 2003

Study Record Updates

Last Update Posted (Estimate)

September 5, 2016

Last Update Submitted That Met QC Criteria

September 2, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DirecNet 003
  • HD041890
  • HD041919-01
  • HD041908-01
  • HD041906-01
  • HD041918-01
  • HD041915

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus, Insulin-Dependent

Clinical Trials on GlucoWatch® G2™ Biographer (GW2B)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Vietnam

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe