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

非洲青年糖尿病：改善血糖时间范围

• 批准号: 10362765
• 负责人: Antoinette M. Moran
• 金额: $ 59.67万
• 依托单位: UNIVERSITY OF MINNESOTA
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-04-01 至 2027-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10362765
• 关键词: AIDS/HIV problem; Acute; Address; African; Age; Anti-HIV Agents; Area; Attention; Blinded; Blood Glucose Self-Monitoring; Caring; Child; Childhood; Chronic; Client satisfaction; Clinical; Clinical Research; Communities; Complications of Diabetes Mellitus; Control Groups; Cost Analysis; Country; Data; Diabetes Mellitus; Education; Educational workshop; Endocrinologist; Ensure; Ethics; Family; Glucose; Glycosylated hemoglobin A; Goals; Good Clinical Practice; Health Personnel; Hour; Human; Hypoglycemia; Income; Individual; Insulin; Insulin-Dependent Diabetes Mellitus; Knowledge; Low income; Measurement; Measures; Medical; Mentors; Metabolic Control; Minnesota; Monitor; Outcome; Outcome Measure; Patient Education; Patient Participation; Patients; Pediatric Research; Phase; Pilot Projects; Protocols documentation; Quality of life; Randomized Clinical Trials; Randomized Controlled Trials; Research; Resource-limited setting; Resources; Scanning; Services; System; Technology; Testing; Time; Training; Uganda; Universities; Variant; Visit; Youth; care outcomes; cohort; cost effective; data integrity; design; diabetes control; diabetes education; diabetes mellitus therapy; diabetes risk; effective therapy; experience; glucose monitor; health care disparity; high risk; improved; primary outcome; programs; skills; societal costs; test strip

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.

抽象的 尽管有重大改进，但在1型糖尿病（T1D）中仍存在大量医疗保健和结果分布 低收入国家。在我们最近对68名T1D非洲青年的研究中，患者接受了治疗， 由训练有素的小儿内分泌学家教育，对血糖（SMBG）进行自我监控 每天2.1倍，可以使用足够数量的胰岛素。平均HBA1C为11％。盲目继续 葡萄糖监测（CGM）表现出高血糖和低血糖的极端。葡萄糖百分比时间 范围（TIR，70-180 mg/dl）仅为30％，诸如葡萄糖（葡萄糖<54 mg/dl）为7％，更多 比80％的受试者每天花费约2个小时降血糖。当前的做法使这些孩子失败，谁 糖尿病急性和慢性并发症的风险很高。 该RCT旨在通过测试实现的假设来改善东非青年4-26岁的T1D护理 用闪光CGM连续监测葡萄糖水平的患者将改善葡萄糖TIR，并且这种疗法 在一个低资源国家的环境下将具有成本效益。所有受试者将接受相同的每月糖尿病 教育。在头六个月中，一半的患者（n = 90）将获得无盲的闪光CGM，以便他们看到自己的 实时葡萄糖水平，而一半（n = 90，对照组）每天进行≥3倍血液的自我监测 穿着盲CGM进行端点测量时，葡萄糖是通过指尖（SMBG）进行的。主要结果 测量在6个月时评估TIR。 6个月后，无盲的CGM队列将继续进行此治疗 再过6个月，以评估1年无盲CGM治疗的影响。对照组将切换到 无盲的CGM月6-12个月。 这项研究中的所有患者，包括对照组的患者，都将接受更强化的教育，更大的教育 糖尿病团队的注意力和测试条要比当今常用的更多。如果这种方法结果 与也接受CGM的患者相比 这项研究将通过证明不需要CGM治疗和 取而代之的是，需要将重点放在与医疗团队的患者教育和互动上。但是，如果 CGM通过减少过度和 低血糖，那么道德问题不是是否在资源差的环境中提供这种疗法，而是如何提供这种疗法，而是如何提供这种疗法 使其负担得起。此类决定必须以从儿童获得的数据来指导 在低收入国家中发现的设置。该协议的目的是获取这些数据。