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

非洲青年糖尿病：改善血糖时间范围

基本信息

批准号：
10565952
负责人：
Antoinette M. Moran
金额：
$ 56.91万
依托单位：
UNIVERSITY OF MINNESOTA
依托单位国家：
美国
项目类别：
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/10565952
关键词：
Acute African Age Anti-HIV Agents Area Attention Blinded Blood Glucose Self-Monitoring Caring Child Childhood Chronic Client satisfaction Clinical Clinical Research Communication Communities Complications of Diabetes Mellitus Continuous Glucose Monitor Control Groups Cost Analysis Country Data Diabetes Mellitus Distress Education Educational workshop Endocrinologist Ensure Ethics Family Glucose Glycosylated hemoglobin A Goals Good Clinical Practice HIV/AIDS 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, Controlled Trials Research Resource-limited setting Resources Scanning Services System Technology Testing Time Training Uganda Universities Variant Visit Youth cohort cost effective data integrity design diabetes control diabetes education diabetes mellitus therapy diabetes risk effective therapy experience health care disparity high risk improved primary outcome programs randomized, clinical trials skills societal costs test strip

项目摘要

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.

抽象的尽管取得了重大进步，但 1 型糖尿病 (T1D) 的医疗保健和结果仍存在显着差异在我们最近对 68 名患有 T1D 的非洲青年进行的研究中，低收入国家与高收入国家进行了比较。由训练有素的儿科内分泌学家教育，平均进行血糖自我监测（SMBG） 2.1x/天，并获得足够量的胰岛素，盲法连续平均 HbA1c 为 11%。血糖监测 (CGM) 显示极端的高血糖和低血糖百分比。范围（TIR，70-180 mg/dl）仅为 30%，低血糖时间（血糖 <54 mg/dl）为 7%，更多超过 80% 的受试者每天花大约 2 小时进行降血糖，目前的做法对这些孩子来说是失败的。患有急性糖尿病和慢性并发症的风险非常高。该随机对照试验旨在通过检验以下假设来改善东非 4-26 岁青少年的 T1D 护理：患者通过快速 CGM 持续监测血糖水平将改善血糖 TIR，并且该疗法在资源匮乏的国家，所有受试者每月接受相同的糖尿病治疗将具有成本效益。在前 6 个月，一半患者 (n=90) 将接受非盲式快速 CGM，以便他们能够看到自己的情况。实时血糖水平，而一半（n = 90，对照组）将进行≥3次的每日自我血液监测佩戴盲法 CGM 进行终点测量时通过指尖测血糖 (SMBG) 主要结果。 TIR 测量在 6 个月时进行评估 6 个月后，非盲性 CGM 队列将继续接受这种治疗。另外 6 个月的时间来评估 1 年非盲 CGM 治疗的影响，对照组将改用该疗法。第 6-12 个月进行非盲 CGM。本研究中的所有患者，包括对照组患者，都将接受更强化的教育、更多的治疗如果这种方法有效的话，会得到糖尿病团队的关注，并且会得到比现在常见的更多的试纸。与同时接受 CGM 的患者相比，对照组受试者的葡萄糖 TIR 改善水平相似，这项研究将发挥重要作用，证明不需要 CGM 治疗，并且相反，需要更多地关注患者教育以及与医疗团队的互动。 CGM 通过减少高血糖和糖尿病代谢控制，显着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中提供这种治疗，而是如何提供为了使其负担得起，此类决定必须以从儿童那里获得的具体且独特的数据为指导。该协议的目标是获取这些数据。