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

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。这项试点试验是由美国国立卫生研究院资助的五个中心组成的儿童糖尿病研究网络(DirecNet)进行的。此前，我们进行了一项试点试验，以研究下午锻炼对50名使用强化糖尿病治疗方案的T1 DM儿童在锻炼期间和第二天晚上发生低血糖的相对风险的影响。这项研究的结果支持了公认的临床观察，即运动对降低T1 DM儿童运动期间和运动后的血糖水平都有好处。我们的发现还支持使用灵活的糖尿病管理方案，试图在运动期间或运动后的晚上调整食物摄入量和胰岛素剂量，以降低低血糖的风险。虽然人们普遍认为降低胰岛素可以预防低血糖，但降低多少胰岛素还没有得到很好的研究。在目前的研究中，DirecNet的目标是检查运动中不使用胰岛素剂量与全量使用胰岛素的效果。55名年龄在8岁到17岁之间的儿童将在全美5个临床中心注册。这项研究需要对GCRC进行两次访问，每次访问时间约为20小时，间隔2至4周。受试者将通过持续的血糖监测和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。我们将提供标准午餐。在下午晚些时候，受试者将被要求在跑步机上步行15分钟，然后休息5分钟。这将再重复三次，总共75分钟。在其中一次访问中，受试者将在锻炼时通过泵获得他们的标准基础胰岛素。在另一次检查中，泵将被停止，受试者在锻炼期间将不接受基础胰岛素。将密切监测血糖，并适当使用碳水化合物零食和静脉注射胰岛素。受试者将得到一顿标准的晚餐。受试者将留下来过夜。他们将吃一份睡前零食，其中含有他们在一天锻炼中通常会吃的碳水化合物的数量。他们的血糖将按照给儿童权利中心工作人员的时间表由HGM用手指检测。

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.