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. This pilot trial is being conducted by the Diabetes Research Network in Children (DirecNet), an NIH funded consortium of five centers in the US. Previously we conducted a pilot trial to study the effect of afternoon exercise on the relative risk of hypoglycemia during exercise and the following night in 50 children with T1DM, who were using an intensive diabetes management regimen. The findings of this study supported the well-recognized clinical observation that exercise has benefit in lowering plasma glucose levels both during and following exercise in children with T1DM. Our findings also supported the use of flexible diabetes management regimens that attempt to adjust food intake and insulin dosing during or on evenings following exercise to reduce the risk of hypoglycemia. Although it is widely understood that decreasing insulin would prevent hypoglycemia, how much to decrease insulin has not been well studied. In the present study DirecNet aims to examine the effect of no insulin dose during exercise in comparison to full dose. 55 children ages 8 to 17 inclusive will be enrolled in 5 clinical centers across the US. The study will require two visits to the GCRC lasting approximately 20 hours each, occurring 2 to 4 weeks apart. The subjects will have their blood glucose levels monitored by continuous glucose monitoring as well as frequent laboratory tests through an IV catheter. A standard lunch will be provided. In the late afternoon, subjects will be asked to walk on a treadmill for 15 minutes followed by a five minute rest period. This will be repeated three additional times for a total of 75 minutes. During one of the visits, the subjects will receive their standard basal insulin through their pump while exercising. During the other visit, the pump will be stopped and subjects will receive no basal insulin during the exercise period. Blood sugars will be monitored closely and carbohydrate snacks and IV insulin will be administered appropriately. Subjects will receive a standard dinner. The subjects will stay overnight. They will eat a bedtime snack containing the number of carbohydrates they would normally eat on a day of exercise. Their blood sugars will be checked by finger stick with the HGM following the schedule given to the CRC staff.
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