Diabetes in African Youth, Improving Glucose Time-In-Range (DAYTime): A Randomized Controlled Trial

IntroductionDisparities in healthcare access and clinical outcomes exist in individuals with type 1 diabetes (T1D) in less- versus well-resourced countries. An observational study of East African youth with T1D found an average haemoglobin A1c level of 11%. Blinded continuous glucose monitoring (CGM) demonstrated extremes of both hyper- and hypoglycemia. This randomised clinical trial (RCT) aims to test the hypothesis that enabling Ugandan youth with T1D to monitor glucose levels with CGM technology will improve glucose time-in-range (TIR, glucose levels 3.9-10.0 mmol/L). Methods and AnalysisUgandan youth with T1D (n=180, age 4-26 years) will be randomized over five years, August 15, 2022-August 14, 2027, at Mulago or Nsambya Hospitals, Kampala. Half will be placed on unblinded Freestyle Libre 2 CGM for 12 months. The other half will be given sufficient test strips for 3x daily self-monitoring of blood glucose (SMBG) while wearing blinded CGM for 6 months (control group). Current standard-of-care is 2-3 test strips per day. The control group will switch to unblinded CGM months 7-12. All subjects will receive monthly diabetes education. The primary endpoints are 1) the 6-month change from baseline in glucose TIR in those wearing the unblinded CGM compared to those performing SMBG, and 2) cost analysis of CGM compared to 3x/day SMBG, to determine whether this technology is cost effective in a less-resourced country. The primary hypotheses will be tested by linear mixed effects models. Ethics and DisseminationThe protocol was approved by the Mulago Hospital Research Ethical Committee (MHREC 2173), Uganda National Council of Science and Technology (HS2129ES), and the University of Minnesota IRB (STUDY00013430). Results will be disseminated at scientific meetings, policy briefings at the Ugandan Ministry of Health, and peer reviewed journal publications. Clinicaltrials.gov registrationNCT05454176 Protocol Version 4.0, December 5, 2022 Strengths and Limitations of this StudyO_LIThe study will be conducted at the two largest diabetes clinics in Uganda, involving a large number and wide age range of children and young adults from a less-resourced nation. C_LIO_LIAll participants will receive extensive diabetes education. C_LIO_LIThe University of Minnesota will monitor the study and will provide ongoing research education, training the Ugandan team for involvement in this and future RCTs. C_LIO_LIThe inclusion of Ministry of Health economists allows assessment of the real-world practicality of this intervention. C_LIO_LIThe study is being conducted in an urban setting, with no rural comparison. C_LI