Trial record 7 of 48 for:    diabetes | NICHD [Lead] | NIH

Pilot Study of the Navigator Continuous Glucose Monitor

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00166673
First received: September 9, 2005
Last updated: January 10, 2008
Last verified: December 2006
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Insulin-Dependent
Device: FreeStyle Navigator Continuous Glucose Monitoring System
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Pilot Study to Evaluate the Navigator Continuous Glucose Sensor in the Management of Type 1 Diabetes in Children

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • Feasibility of using the Navigator sensor on a daily basis (Average number of sensors used per week, Average number of hours of use per sensor, Number of sensors per week that fail to calibrate)
  • Navigator Accuracy

Secondary Outcome Measures:
  • Psychosocial Questionnaires
  • Exploratory assessment of impact of Navigator on HbA1c

Estimated Enrollment: 60
Study Start Date: August 2005
Study Completion Date: August 2007
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   3 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00166673

Locations
United States, California
Division of Pediatric Endocrinology and Diabetes, Stanford University
Stanford, California, United States, 94305-5208
United States, Colorado
Barbara Davis Center for Childhood Diabetes, University of Colorado
Aurora, Colorado, United States, 80010
United States, Connecticut
Department of Pediatrics, Yale University School of Medicine
New Haven, Connecticut, United States, 06519
United States, Florida
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207
Jaeb Center for Health Research
Tampa, Florida, United States, 33647
United States, Iowa
Department of Pediatrics, University of Iowa Carver College of Medicine
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
Investigators
Study Chair: William V Tamborlane, M.D. Yale University
  More Information

Publications:
Buckingham B, Ruedy K, Kollman C, Beck R, Tamborlane W, Mauras N, Weinzimer S, Chase P, Tsalikian E; and the Diabetes Research in Children Network (DirecNet) Study Group. Family Assessment of the Utility of the DirecNet Applied Treatment Algorithm (DATA) for Insulin Adjustments in Real-Time and Retrospective Analyses of Continuous Glucose Monitoring (CGM) Diabetes 2006; 55(Suppl.1): A453
Fiallo-Scharer R, Tamborlane W, Buckingham B, Wysocki T, Weinzimer S, Tsalikian E, Beck R, Ruedy K, Kollman C; and the Diabetes Research in Children Network (DirecNet) Study Group. Diabetes Research in Children Network (DirecNet) Pilot Study to Evaluate the FreeStyle Navigator® Continuous Glucose Monitoring System in the Management of T1D in Children. Diabetes 2006; 55(Suppl.1): A452.
Messer L, Ruedy K, Coffey J, Englert K, Caswell K, Steffen A; and the Diabetes Research in Children Network (DirecNet) Study Group. Pediatric Educators' Role in Successful Continuous Glucose Monitoring. Diabetes 2007; 56(Suppl.1): A617.
Diabetes Research in Children Network (DirecNet). Use of the DirecNet Applied Treatment Algorithm (DATA) for Diabetes Management with a Real-Time Continuous Glucose Monitor (the FreeStyle Navigator). Pediatric Diabetes 2007; 8:1-6.

ClinicalTrials.gov Identifier: NCT00166673     History of Changes
Other Study ID Numbers: DirecNet 006, HD041890, HD041919, HD041908, HD041906, HD041918, HD041915
Study First Received: September 9, 2005
Last Updated: January 10, 2008
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Diabetes Mellitus, Insulin-Dependent
Type 1 Diabetes
Continuous Glucose Monitoring Devices
Electronic Data Collection

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 24, 2014