NAVIGATOR: GLUCOSE SENSOR IN THE MANAGEMENT OF TYPE-1 DIABETES IN CHILDREN

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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. Hypothesis: Resistance to frequent blood glucose monitoring is a major impediment to attaining good (lower HbA1c level) glucose control. The Diabetes Control and Complications Trial (DCCT) convincingly proved that glucose control closer-to-normal range ("tight" glycemic control) reduced the likelihood of the eye, kidney, and nerve complications of diabetes. Increasing the frequency of glucose monitoring was an important aspect of attaining improved glucose control. As a result of the DCCT, many physicians have attempted to keep children and adults in very "tight" glucose control. Unfortunately, the DCCT study also showed that the incidence of severe hypoglycemia was three times higher in the intensively-treated group compared with the standard treatment group. The tools to safely implement tight glycemic control were not available to the DCCT. The Navigator(TM) by TheraSense has been developed to assist in closer monitoring of glucose levels. We expect that the Navigator continuous glucose monitor will have an important role in the management of diabetes in children. Therefore, the results of this study are likely to be beneficial for children with diabetes. We hypothesize that the blood sugar information from the sensor along with the instructions provided for management decisions will be useful for the subject's diabetes self-management. This pilot study will include approximately 30 subjects with Type-1 Diabetes aged 3 to 7 years old, an exercise session of moderate intensity is completed in the afternoon. This allows for assessment of Navigator function during exercise and assessment of the accuracy of detecting changes in blood glucose. For subjects of sufficient weight to accommodate the volume of blood required, blood glucose measurements are made every 10 min for one hr after breakfast. This allows for assessment of the accuracy of the Navigator in detecting change during a period of rising blood glucose. The pre-admission Navigator, HGM, and pump data are reviewed and changes are made to diabetes management as needed. Subjects and parents are provided with extensive teaching to use the protocol-developed algorithms for changes to diabetes management to be used in real time based on Navigator data after the subject leaves the GCRC. Each subject is provided with the instructions for downloading the Navigator.