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

运动期间基础胰岛素对 1 型糖尿病儿童低血糖的影响

• 批准号: 7374401
• 负责人: H PETER CHASE
• 金额: $ 3.62万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-04-24 至 2007-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7374401
• 关键词: children; exercise; hypoglycemia; insulin

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.

该子项目是利用 NIH/NCRR 资助的中心拨款提供的资源的众多研究子项目之一。子项目和研究者 (PI) 可能已从另一个 NIH 来源获得主要资金，因此可以在其他 CRISP 条目中得到体现。列出的机构是中心的机构，不一定是研究者的机构。该试点试验由儿童糖尿病研究网络 (DirecNet) 进行，该网络是 NIH 资助的由美国五个中心组成的联盟。此前，我们对 50 名使用强化糖尿病管理方案的 1 型糖尿病儿童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结果，即运动有利于降低 T1DM 儿童运动期间和运动后的血糖水平。我们的研究结果还支持使用灵活的糖尿病管理方案，尝试在运动期间或运动后晚上调整食物摄入量和胰岛素剂量，以降低低血糖风险。尽管人们普遍认为减少胰岛素可以预防低血糖，但减少胰岛素的程度尚未得到充分研究。在本研究中，DirecNet 旨在检查运动期间不注射胰岛素与全剂量胰岛素相比的效果。 55 名 8 岁至 17 岁（含）的儿童将在美国 5 个临床中心入组。该研究需要两次访问 GCRC，每次持续约 20 小时，间隔 2 至 4 周。受试者将通过连续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。下午晚些时候，受试者将被要求在跑步机上行走 15 分钟，然后休息 5 分钟。此过程将再重复 3 次，总共 75 分钟。在其中一次访问期间，受试者将在运动时通过泵接受标准基础胰岛素。在另一次访问期间，泵将停止，并且受试者在运动期间将不接受基础胰岛素。将密切监测血糖，并适当施用碳水化合物零食和静脉注射胰岛素。受试者将收到标准晚餐。受试者将过夜。他们会吃睡前零食，其中含有他们在一天锻炼时通常吃的碳水化合物的数量。他们的血糖将按照 CRC 工作人员提供的时间表通过 HGM 进行指尖采血检查。