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

描述(申请人提供)：众所周知，对1型糖尿病(T1D)的良好控制可以减少长期并发症，如眼部疾病(视网膜病变)、肾脏损害(肾病)和神经损害(神经病变)。T1D控制不良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，因此他们将从改善控制中获益最多。糖尿病控制不佳的可能原因有很多，包括对家庭血糖监测的遵从性较差。没有血糖数据会阻碍适当的胰岛素剂量，特别是当血糖升高需要额外的快速作用胰岛素时。连续血糖监测(CGM)允许实时测量血糖，而无需重复使用手指检查血糖。然而，使用CGM设备的患者仍然应该使用手指血糖来做出治疗决定，例如治疗低血糖或高血糖。认识到[控制不佳的T1D患者]是如何检查他们的血糖的，重要的是探索通过CGM产生的用于治疗决策的血糖数据是否会比他们通常缺乏血糖数据更好。因此，我们建议进行一项研究，实时评估CGM在青少年前期和T1D控制不佳的青少年中的使用情况，而不强制用手指确认血糖。我们假设糖尿病控制会有所改善，因为这些患者将使用传感器数据来做出治疗决定，而不是使用手指检测血糖，而不是过于频繁地进行血糖检测。[26]10至18岁T1D控制不良的患者将参加这项为期9个月的先导性研究。在接受CGM设备一周后，希望继续研究的实际使用CGM的患者将被随机分配到CGM或标准护理组。三个月后，标准护理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。入选的患者将再接受6个月的随访。研究结果将包括糖尿病控制(基于A1c)、几个血糖指数、CGM使用频率和BG检查频率的变化。这项先导性研究的结果将被用来创建一项更大规模的试验，涉及更多T1D控制不佳的受试者。

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.