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

摘要 尽管取得了重大进展，但在1型糖尿病（T1 D）中， 低收入国家vs高收入国家在我们最近对68名非洲T1 D青年的研究中，患者接受了治疗， 接受过培训的儿科内分泌学家的教育，进行自我血糖监测（SMBG），平均 2.1x/天，并可获得足量的胰岛素。平均HbA 1c为11%。设盲连续 血糖监测（CGM）显示极端的高血糖和低血糖。葡萄糖时间百分比 范围（TIR，70-180 mg/dl）仅为30%，低血糖时间（葡萄糖<54 mg/dl）为7%， 超过80%的受试者每天花费约2小时降低血糖。目前的做法正在使这些儿童失望， 患糖尿病急性和慢性并发症的风险很高。 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T1 D护理： 患者使用闪光CGM连续监测葡萄糖水平将改善葡萄糖TIR，并且该疗法 在低资源国家的环境中，将具有成本效益。所有受试者将每月接受相同的糖尿病治疗 教育在前6个月，一半的患者（n=90）将接受非盲闪光CGM，以便他们可以看到他们的 真实的血糖水平，而一半（n=90，对照组）将进行≥ 3次每日自我血糖监测 佩戴盲态CGM进行终点测量时，通过手指戳测血糖（SMBG）。主要结局 在6个月时评估指标TIR。6个月后，非盲CGM队列将继续接受这种治疗 再持续6个月，以评估1年非盲态CGM治疗的影响。控制组将切换到 6-12个月非盲CGM。 本研究中的所有患者，包括对照组患者，将接受更强化的教育， 糖尿病团队的关注，以及比今天通常可用的更多的测试条。如果这种做法导致 在对照受试者中葡萄糖TIR的改善水平与也接受CGM的患者相似， 这项研究将通过证明不需要CGM治疗来提供重要的服务， 相反，需要更多地关注患者教育和与医疗团队的互动。但如果 CGM通过减少高血糖和低血糖，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贫乏的环境中提供这种治疗，而是如何提供这种治疗。 让它变得更便宜这些决定必须以从儿童那里获得的数据为指导， 在低收入国家中发现。本方案的目的是获得这些数据。

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.