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FreeStyle Navigator Continuous Glucose Monitoring System Use in Children With Type 1 Diabetes Using Glargine-Based Multiple Daily Dose Regimens

Results of a pilot trial Diabetes Research in Children Network (DirecNet) Study Group

¹ Department of Pediatrics, Yale University School of Medicine, New Haven, Connecticut
² Jaeb Center for Health Research, Tampa, Florida
³ University of Iowa Health Care, Iowa City, Iowa
⁴ University of Colorado Health Sciences Center, Denver, Colorado
⁵ Nemours Children's Clinic, Jacksonville, Florida
⁶ Division of Psychology and Psychiatry, Nemours Children's Clinic, Jacksonville, Florida
⁷ Department of Pediatric Endocrinology, Yale University School of Medicine, New Haven, Connecticut

Address correspondence and reprint requests to Stuart Weinzimer, MD, c/o DirecNet Coordinating Center, Jaeb Center for Health Research, 15310 Amberly Dr., Suite 350, Tampa, FL 33647. E-mail: direcnet@jaeb.org

Abbreviations: MDI, multiple daily injection

The first 20% of the full text of this article appears below.

	INTRODUCTION

 
In a previous pilot study of the FreeStyle Navigator Continuous Glucose Monitoring System, hereafter referred to as "Navigator," in 30 children and adolescents with type 1 diabetes using insulin pumps, we found that Navigator use averaged >130 h per week over 13 weeks and mean A1C level dropped from 7.1 ± 0.6 to 6.8 ± 0.7% (P = 0.02) (1). The current study evaluated whether the Navigator was similarly tolerated over 13 weeks in 27 children aged 4–17 years with type 1 diabetes using glargine-based, multiple daily injection(MDI) insulin regimens. Subjects averaged >100 h/week of Navigator use. Mean A1C level fell from 7.9 ± 1.0% at baseline to 7.3 ± 0.9% at 13 weeks (P = 0.004). High satisfaction with the Navigator was reported on the Continuous Glucose Monitor Satisfaction Scale. These encouraging pilot study results support the inclusion of MDI users in longer-term randomized clinical trials of continuous glucose monitors.

	RESEARCH DESIGN AND METHODS—

 
Institutional review boards at each of the Diabetes Research in Children Network (DirecNet) centers approved the study protocol and consent/assent forms. Research methods were virtually identical to those employed in our previous Navigator (Abbott Diabetes Care; Alameda, CA) study (1) except that all subjects were treated with glargine-based MDI treatment. Other eligibility requirements were as follows: subjects must 1) be aged 3–17 years, 2) have type 1 diabetes for a duration 1 year, 3) have access to a home computer equipped with E-mail, and 4) have a parent/older subject who comprehended English. Subjects were excluded for asthma, cystic fibrosis, psychiatric disorder, and use of glucocorticoids. Subjects were selected for participation from the existing patient population at each center.

There was a 1-week run-in period during which Navigator use was blinded to collect baseline glucose data, followed . . . [Full Text of this Article]

	RESULTS—

 

	CONCLUSIONS—

 

	APPENDIX

 
TheDiabetes Research in Children Network (DirecNet) study group, by clinical center listed in alphabetical order.

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