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

Sponsor

Jaeb Center for Health Research (Other)

Overall Status

Completed

CT.gov ID

NCT00069615

Collaborator

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

Enrollment

Locations

3.9

Duration (Months)

2.5

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Insulin-Dependent	Device: GlucoWatch® G2™ Biographer (GW2B) Device: Continuous Glucose Monitoring System™ (CGMS)	Phase 4

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 Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Official Title:

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

Study Start Date :

Feb 1, 2003

Study Completion Date :

Jun 1, 2003

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

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