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. 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 in the DCCT. As a result of the 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 by TheraSense has been developed to assist in closer monitoring of glucose levels. The proper role of the Navigator in the management of type 1 diabetes in children has not been determined. We are planning a randomized clinical trial (RCT) to compare the effect on glycemic control, hypoglycemia, and quality of life of using a Navigator versus standard care. As a prelude to the RCT, we will conduct a pilot study in which subjects will use the Navigator in their home environment.
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