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

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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.