Pilot Study of the Navigator Continuous Glucose Monitor

NCT00166673 | Completed Phase 2

• 7 other identifiers: DirecNet 006HD041890HD041919HD041908HD041906HD041918HD041915
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Diabetes Mellitus, Insulin-Dependent

Keywords

Diabetes Mellitus, Insulin-Dependent; Type 1 Diabetes; Continuous Glucose Monitoring Devices; Electronic Data Collection

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Psychosocial Questionnaires

• Exploratory assessment of impact of Navigator on HbA1c

Interventions

FreeStyle Navigator Continuous Glucose Monitoring System DEVICE

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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.

Sponsors & Collaborators

• Jaeb Center for Health Research: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (6)

Division of Pediatric Endocrinology and Diabetes, Stanford University

Stanford, California, 94305-5208, United States

Location

Barbara Davis Center for Childhood Diabetes, University of Colorado

Aurora, Colorado, 80010, United States

Location

Department of Pediatrics, Yale University School of Medicine

New Haven, Connecticut, 06519, United States

Location

Nemours Children's Clinic

Jacksonville, Florida, 32207, United States

Location

Jaeb Center for Health Research

Tampa, Florida, 33647, United States

Location

Department of Pediatrics, University of Iowa Carver College of Medicine

Iowa City, Iowa, 52242, United States

Location

Related Publications (7)

• 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

  RESULT

• 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.

  RESULT

• Wilson DM, Beck RW, Tamborlane WV, Dontchev MJ, Kollman C, Chase P, Fox LA, Ruedy KJ, Tsalikian E, Weinzimer SA; DirecNet Study Group. The accuracy of the FreeStyle Navigator continuous glucose monitoring system in children with type 1 diabetes. Diabetes Care. 2007 Jan;30(1):59-64. doi: 10.2337/dc06-1407.

  PMID: 17192334 RESULT

• Diabetes Research in Children Network (DirecNet) Study Group. Relative accuracy of the BD Logic and FreeStyle blood glucose meters. Diabetes Technol Ther. 2007 Apr;9(2):165-8. doi: 10.1089/dia.2006.0005.

  PMID: 17425442 RESULT

• Diabetes Research in Children Network (DirecNet) Study Group; Buckingham B, Beck RW, Tamborlane WV, Xing D, Kollman C, Fiallo-Scharer R, Mauras N, Ruedy KJ, Tansey M, Weinzimer SA, Wysocki T. Continuous glucose monitoring in children with type 1 diabetes. J Pediatr. 2007 Oct;151(4):388-93, 393.e1-2. doi: 10.1016/j.jpeds.2007.03.047. Epub 2007 Aug 24.

  PMID: 17889075 RESULT

• 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.

  RESULT

• Diabetes Research In Children Network (DirecNet) Study Group; Buckingham B, Xing D, Weinzimer S, Fiallo-Scharer R, Kollman C, Mauras N, Tsalikian E, Tamborlane W, Wysocki T, Ruedy K, Beck R. Use of the DirecNet Applied Treatment Algorithm (DATA) for diabetes management with a real-time continuous glucose monitor (the FreeStyle Navigator). Pediatr Diabetes. 2008 Apr;9(2):142-7. doi: 10.1111/j.1399-5448.2007.00301.x. Epub 2008 Jan 24.

  PMID: 18221427 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• William V Tamborlane, M.D.

  Yale University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 14, 2005
• Study Start: August 1, 2005
• Study Completion: August 1, 2007
• Last Updated: September 5, 2016

Record last verified: 2016-09

Locations

US (6)