Diabetes in African Youth: Improving Glucose Time-In-Range

摘要 尽管有了重大改善，但在医疗保健和预后方面仍存在显著差异 低收入国家与高收入国家。在我们最近对68名患有T1D的非洲青年进行的研究中，患者接受了治疗和 接受训练有素的儿科内分泌科医生的培训，平均进行血糖自我监测(SMBG) 每天2.1倍，并能获得足够量的胰岛素。平均糖化血红蛋白为11%。盲连续化 血糖监测(CGM)显示了极端的高血糖和低血糖。葡萄糖百分比时间- 范围(TIR，70-180 mg/dl)仅为30%，低血糖时间(血糖&lt；54 mg/dl)为7%， 超过80%的受试者每天花~2小时降血糖。目前的做法让这些孩子失望了，他们 患糖尿病急性和慢性并发症的风险非常高。 这项随机对照试验旨在通过检验以下假设来改善东非4-26岁青年的T1D护理： 患者使用闪光CGM持续监测血糖水平会改善血糖TIR，这种治疗方法 将在低资源国家的背景下具有成本效益。所有受试者每月都会患上相同的糖尿病 教育。在前6个月，一半的患者(n=90)将被给予非盲目闪光CGM，以便他们可以看到他们的 血糖水平实时监测，而另一半(n=90，对照组)将执行≥3次每日自我血液监测 当戴着盲目的CGM进行终点测量时，通过指戳检测血糖(SMBG)。主要结果是 措施，TIR，评估在6个月。6个月后，未盲目的CGM队列将继续接受这种治疗 再持续6个月，以评估1年非盲法CGM治疗的影响。控制组将切换到 非盲目CGM 6-12个月。 这项研究中的所有患者，包括控制组的患者，都将接受更密集的教育，更多的 糖尿病团队的关注，以及比目前常见的更多的试纸。如果这种方法的结果是 与同样接受CGM治疗的患者相比，对照组患者的血糖TIR改善程度相似， 这项研究将发挥重要的作用，证明没有必要进行CGM疗法和 相反，这种更多的关注需要放在患者教育和与医疗团队的互动上。但如果 CGM通过减少高血糖和高血糖显著改善糖尿病代谢控制 低血糖，那么伦理问题不是是否在资源匮乏的环境下提供这种治疗，而是如何提供这种治疗 让它变得负担得起。这样的决定必须以从儿童那里获得的具体和独特的数据为指导 低收入国家的环境。该协议的目标是获得这些数据。

ABSTRACT Despite major improvements, significant disparities in healthcare and outcomes exist in type 1 diabetes (T1D) in low vs high income countries. In our recent study of 68 African youth with T1D, patients were treated and educated by trained pediatric endocrinologists, performed self-monitoring of blood glucose (SMBG) an average of 2.1x/day, and had access to sufficient quantities of insulin. Average HbA1c was 11%. Blinded continuous glucose monitoring (CGM) demonstrated extremes of both hyper- and hypoglycemia. Glucose percent time-in- range (TIR, 70-180 mg/dl) was only 30%, and time-in-hypoglycemia (glucose <54 mg/dl) was 7%, with more than 80% of subjects spending ~ 2 hours a day hypoglycemic. Current practices are failing these children, who are at very high risk for diabetes acute and chronic complications. This RCT aims to improve T1D care in East African youth age 4-26 years by testing the hypothesis that enabling patients to continuously monitor glucose levels with flash CGM will improve glucose TIR, and that this therapy will be cost effective in the setting of a low-resource country. All subjects will receive identical monthly diabetes education. For the first 6 months, half of patients (n=90) will be given unblinded flash CGM so they can see their glucose levels in real time, while half (n=90, the control group) will perform ≥3x daily self-monitoring of blood glucose by fingerpoke (SMBG) while wearing a blinded CGM for endpoint measurement. The primary outcome measure, TIR, is assessed at 6 months. After 6 months, the unblinded CGM cohort will continue on this treatment for another 6 months to assess the impact of 1 year of unblinded CGM therapy. The control group will switch to unblinded CGM months 6-12. All patients in this study, including those in the control group, will receive more intensive education, greater attention from the diabetes team, and more test strips than are commonly available today. If this approach results in similar levels of improvement in glucose TIR in control subjects compared to patients who also receive CGM, this study will have performed an important service by demonstrating that there is no need for CGM therapy and that more focus, instead, needs to be placed on patient education and interaction with the medical team. But if CGM leads to significantly greater improvement in diabetes metabolic control by reducing hyper-and hypoglycemia, then the ethical question is not whether to provide this therapy in resource poor settings, but how to make it affordable. Such decisions must be guided by data obtained from children in the specific and unique settings found in low income nations. The goal of this protocol is to obtain these data.