PILOT ST -EVAL NAVIGATOR CONTINUOUS GLUCOSE SENSOR IN MANGMT OF TYPE1 DIABETES

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The Navigator¿ by TheraSense has been developed to assist in closer monitoring of glucose levels. In this pilot study funded by the NIH, feasibility of using the Navigator and its accuracy will be studied in preparation for a randomized clinical trial. 30 children (ages 3 to 17 years, inclusive) with type 1 diabetes will be enrolled across 5 clinical centers. Each subject will be trained to use the Navigator at enrollment and will wear it at home for approximately 1 week. The subjects will enter information but be blinded to the glucose levels. At the end of the week, subjects will spend 24 hours in the clinical research center wearing two Navigator devices. All subjects will have frequent blood sampling and a meal-induced hyperglycemia test. Subjects over the age of seven will complete a treadmill exercise test. Prior to discharge, subjects will be given a set of dosing algorithms, which will instruct them how to use the Navigator data to make changes to their diabetes regimen. Subjects will have follow-up visits at 1, 3, 7, and 13 (+1) weeks after the CRC admission and phone contacts at 3 days (+1 day), then at 2, 4, 8, and 10 weeks (+1 week) post CRC admission. The purpose of the visits and calls will be to review their diabetes management and assess compliance with use of the algorithms. Each week subjects will be asked to download the Navigator and email the results. At the 13-week visit, subjects may volunteer to use the Navigator for another 13 weeks. There will be no investigator-initiated contact during this time, but families may contact study personnel freely.