BASAL INSULIN EFFECT DURING EXERCISE ON HYPOGLYCEMIA IN CHILD W/TYPE 1 DIABETES

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。这项试点试验由儿童糖尿病研究网络（DirecNet）进行，该网络是由美国国立卫生研究院资助的五个中心组成的联盟。之前，我们进行了一项试点试验，研究下午运动对运动期间和第二天晚上低血糖的相对风险的影响，在50名T1DM儿童中，他们正在使用强化糖尿病管理方案。这项研究的结果支持了公认的临床观察，即运动有利于降低T1DM儿童运动期间和运动后的血糖水平。我们的研究结果也支持使用灵活的糖尿病管理方案，试图在运动期间或晚上调整食物摄入和胰岛素剂量，以降低低血糖的风险。虽然人们普遍认为减少胰岛素可以预防低血糖，但减少多少胰岛素还没有得到很好的研究。在目前的研究中，DirecNet的目的是研究运动期间不注射胰岛素与注射胰岛素的效果。55名8至17岁的儿童将在美国的5个临床中心登记。该研究将需要两次访问GCRC，每次持续约20小时，间隔2至4周。受试者将通过持续的血糖监测以及通过静脉导管进行频繁的实验室测试来监测他们的血糖水平。将提供标准午餐。在下午晚些时候，受试者将被要求在跑步机上走15分钟，然后休息5分钟。这将重复三次，共75分钟。在其中一次访问中，受试者将在锻炼时通过泵接受标准的基础胰岛素。在另一次访问中，泵将停止，受试者在运动期间不接受基础胰岛素。密切监测血糖，适当使用碳水化合物零食和静脉注射胰岛素。受试者将享用标准晚餐。受试者将过夜。他们会在睡前吃一些含有碳水化合物的零食，这些碳水化合物是他们在一天的锻炼中正常摄入的。根据中心工作人员提供的时间表，用手指棒和HGM检查血糖。

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.