Real-time use of CGM in adolescents with poorly-controlled type 1 diabetes

描述（由申请人提供）：众所周知，良好控制1型糖尿病（T1 D）可减少长期并发症，如眼部疾病（视网膜病变）、肾损伤（肾病）和神经损伤（神经病变）。患有控制不良的T1 D的儿童和青少年在成年后发生这些糖尿病相关并发症的风险很高，因此他们可以从改善控制中获益最多。糖尿病控制不佳的原因有很多，包括家庭血糖监测依从性差。没有血糖数据会妨碍适当的胰岛素剂量，特别是当血糖升高需要额外的速效胰岛素时。动态血糖监测（CGM）允许在真实的时间内测量血糖，而无需重复手指针刺血糖检查。然而，使用CGM设备的患者仍然应该使用手指针刺血糖来做出治疗决定，例如治疗低血糖或高血糖。认识到如何[不经常控制不良的T1 D患者]检查他们的血糖，重要的是探索通过CGM生成并用于治疗决策的血糖数据是否优于他们通常缺乏血糖数据。因此，我们提出了一项研究，将评估CGM的使用在真实的时间在青春期前和青少年控制不佳的T1 D没有强制性确认血糖的手指针刺。我们假设，糖尿病控制将得到改善，因为这些患者将使用传感器数据来做出治疗决策，而不是不经常进行的手指针刺血糖。[26]例10 - 18岁控制不佳的T1 D患者将入组这项为期9个月的初步研究。在使用CGM器械一周后，实际使用CGM并希望继续研究的患者将被随机分配至CGM或标准治疗组。三个月后，标准治疗组的受试者将开始使用CGM; CGM组中仍在使用CGM的患者将继续使用CGM。入组患者将再随访6个月。研究结果将包括糖尿病控制的变化（基于A1 c），几个血糖指数，CGM使用频率和BG检查频率。该初步研究的结果将用于创建一项更大规模的试验，纳入更多控制不良的T1 D受试者。 公共卫生相关性：1型糖尿病控制不佳的儿童和青少年在成年后患糖尿病相关并发症的风险很高，如眼病、肾损伤或神经损伤。糖尿病控制不佳的一个常见原因是家庭血糖监测依从性差。探索使用通过连续葡萄糖监测生成的血糖数据而不期望频繁的手指针刺检查是否会改善该人群的糖尿病控制是合理的。

DESCRIPTION (provided by applicant): It is well known that good control of type 1 diabetes mellitus (T1D) decreases long-term complications, such as eye disease (retinopathy), kidney damage (nephropathy), and nerve damage (neuropathy). Children and adolescents with poorly controlled T1D are at high risk to develop these diabetes-related complications in adulthood, and thus they stand to gain the most from improving their control. There are many possible reasons for poorly controlled diabetes, including poor compliance with home blood glucose monitoring. Not having blood sugar data prevents proper insulin dosing, especially when blood sugars are elevated requiring extra rapid- acting insulin. Continuous glucose monitoring (CGM) allows the measurement of blood sugars in real time without repeated fingerstick blood sugar checks. However, patients using CGM devices are still supposed to use fingerstick blood sugars for making treatment decisions, such as treating low or high blood sugars. Recognizing how [infrequently patients with poorly- controlled T1D] check their BGs, it is important to explore whether blood sugar data generated via CGM and used for treatment decisions would be better than their usual lack of glucose data. We therefore propose a study that will evaluate CGM use in real time in pre-adolescents and adolescents with poorly controlled T1D without the mandatory confirmation of the blood sugars by fingerstick. We hypothesize that diabetes control will improve because these patients will use sensor data to make treatment decisions rather than fingerstick blood sugars that are done too infrequently. [Twenty-six] patients between 10 and 18 years old with poorly controlled T1D will be enrolled in this 9-month pilot study. After having a CGM device for one week, patients who actually used the CGM who want to continue the study will be randomized to either CGM or Standard Care. After three months, CGM use will be initiated in subjects in the Standard Care group; patients in the CGM group still using CGM will continue to do so. Enrolled patients will be followed for an additional 6 months. Study outcomes will include changes in diabetes control (based on A1c), several glycemic indices, frequency of CGM use, and frequency of BG checks. The results from this pilot study will be used to create a larger trial with more subjects with poorly-controlled T1D. PUBLIC HEALTH RELEVANCE: Children and adolescents with poorly controlled type 1 diabetes are at high risk to develop diabetes-related complications, such as eye disease, kidney damage, or nerve damage, as adults. One common reason for poorly controlled diabetes is poor compliance with home blood glucose monitoring. It is reasonable to explore whether using blood sugar data generated via continuous glucose monitoring without the expectations of frequent fingerstick checks will improve diabetes control in this population.