Pilot Study of the Navigator Continuous Glucose Monitor

Completed · Phase 2/Phase 3

Conditions studied: Diabetes Mellitus, Insulin-Dependent

In brief

This study is being done to find out how accurate the Navigator continuous glucose monitor is in children. It is also being done to see if use of the Navigator can improve blood sugar control and help prevent low blood sugar events. This study has three basic parts: Use of the Navigator at home for one week without being able to see the blood sugar readings; a Baseline visit or a 24-hour admission to a research unit of the hospital to find out how well the Navigator measures the blood sugar; and then 3 months use of the Navigator at home as an aid to diabetes care.

Key facts

Study ID

NCT00166673

Run by

Jaeb Center for Health Research

People needed

60

Starts

2005-08-01

Expected to finish

2007-08-01

Last updated by the study team

2016-09-05

Who can join

Age: 3 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least one year The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.
• Age 3.0 years to less than 18.0 years
• Subject has used a downloadable insulin pump or Lantus with MDI of a short-acting insulin (e.g. Humalog or Novolog) for at least 6 months
• Parent/guardian and subject understand the study protocol and agree to comply with it
• Subjects >9.0 years old and primary care giver (i.e., parent or guardian) comprehend written English
• Subject has a home computer with email access
• For females, subject not intending to become pregnant during the next 3 months
• No expectation that subject will be moving out of the area of the clinical center during the next 3 months
• Informed Consent Form signed by the parent/guardian and Child Assent Form signed by the subject

You may not qualify if…

• The presence of 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.
• 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 subjects from enrollment)
• 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.

Where it is running

• Division of Pediatric Endocrinology and Diabetes, Stanford University — Stanford, California, United States
• Barbara Davis Center for Childhood Diabetes, University of Colorado — Aurora, 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

Full record on ClinicalTrials.gov

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