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

实时动态监测 (CGM) 在 1 型糖尿病控制不佳的青少年中的应用

• 批准号: 8190869
• 负责人: Larry A Fox
• 金额: $ 6.63万
• 依托单位: NEMOURS CHILDREN'S CLINIC
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-07-01 至 2013-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8190869
• 关键词: 18 year old; Adolescent; Adult; Blood Glucose; Blood Glucose Self-Monitoring; Calibration; Child; Complications of Diabetes Mellitus; Data; Devices; Diabetes Mellitus; Dose; Enrollment; Eye diseases; Family; Frequencies; Glucose; Glycemic Index; Home environment; Hypoglycemia; Incidence; Insulin; Insulin-Dependent Diabetes Mellitus; Kidney; Kidney Diseases; Lead; Measurement; Nerve; Neuropathy; Outcome Study; Patients; Phase; Pilot Projects; Population; Randomized; Reading; Research; Retinal Diseases; Risk; Time; base; diabetes control; expectation; glucose monitor; glucose sensor; high risk; improved; monitoring device; patient population; prevent; sensor; standard care; time use

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.

描述（由申请人提供）：众所周知，1 型糖尿病 (T1D) 的良好控制可以减少长期并发症，例如眼部疾病（视网膜病变）、肾脏损伤（肾病）和神经损伤（神经病）。 1 型糖尿病控制不佳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，包括家庭血糖监测依从性差。没有血糖数据会妨碍正确的胰岛素剂量，尤其是当血糖升高需要额外速效胰岛素时。连续血糖监测 (CGM) 可以实时测量血糖，无需重复进行指尖血糖检查。然而，使用 CGM 设备的患者仍然应该使用指尖血糖来做出治疗决策，例如治疗低血糖或高血糖。认识到[很少有控制不佳的 T1D 患者]如何检查他们的血糖后，探索通过 CGM 生成并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是很重要的。因此，我们提出一项研究，将在 T1D 控制不佳的青春期前和青少年中实时评估 CGM 的使用，而无需通过指尖采血强制确认血糖。我们假设糖尿病控制将会得到改善，因为这些患者将使用传感器数据来做出治疗决策，而不是很少进行的指尖采血血糖。 [26] 名 10 至 18 岁、控制不佳的 T1D 患者将参加这项为期 9 个月的试点研究。使用 CGM 设备一周后，实际使用 CGM 并希望继续研究的患者将被随机分配至 CGM 或标准护理。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。入组患者将被额外随访 6 个月。研究结果将包括糖尿病控制的变化（基于 A1c）、一些血糖指数、CGM 使用频率和 BG 检查频率。这项试点研究的结果将用于开展更大规模的试验，纳入更多控制不佳的 1 型糖尿病受试者。 公共卫生相关性：1 型糖尿病控制不佳的儿童和青少年成年后患糖尿病相关并发症的风险很高，例如眼部疾病、肾脏损伤或神经损伤。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。探索使用通过连续血糖监测生成的血糖数据而不期望频繁的指尖采血检查是否会改善该人群的糖尿病控制是合理的。