Continuous Glucose Monitoring Among Patients with Type 1 Diabetes in Rwanda (CAPT1D) Phase I: Feasibility Study.

Background: The development of minimally invasive continuous glucose monitoring systems (CGMs) has transformed diabetes management. CGMs have shown clinical significance by improving time in the euglycemic range, decreasing rates of hypoglycemia, and improving HbA1c. In Rwanda, CGMs are currently not in routine use, and no clinical studies of CGM use were identified in the literature.

Objective: To determine impact and feasibility of real-time CGM use among people living with T1D in Rwanda, through assessment of sensor usage, time in range, rates of hypo-and-hyperglycemia, HbA1c and rates of diabetes-related hospitalizations over time.

Methods: The Continuous Glucose Monitoring Among Patients with Type 1 Diabetes in Rwanda (CAPT1D) study is a single-arm prospective observational study conducted at the Rwandan Diabetes Association (RDA) clinic in Kigali, Rwanda, aiming to assess the impact and feasibility of CGM use in Rwanda. A cohort of 50 participants diagnosed with T1D were enrolled. Participants were at least 21 years old, undergoing multiple daily insulin therapy, and not currently pregnant. Phase I of the study was conducted over 12 months, using the Dexcom G6 CGM. Phase II and Phase III extended CGM use for an additional 6 months respectively, using the next generation, Dexcom G7 CGM. Here we report the quantitative results of the Phase I study.

Results: Participants used the sensor for >80% of the time throughout the study period. A significant increase in time in range was observed within 3 months, and sustained over 12 months. HbA1c decreased significantly in 3 months and stayed lower throughout the 12-month period. Mean HbA1c levels decreased by 2.8% at 6 months (p<0.01) and 3.2% at 12 months (p<0.01) A total of 12 diabetes-related hospitalizations were reported during the study period. No cases of DKA or episodes of severe hypoglycemia occurred.

Conclusions: Significant and meaningful improvements in key glycemic indices indicate the potential feasibility and impact of CGM among people living with T1D in Rwanda. Future studies could be designed to include pre- and post-intervention analysis to determine the effectiveness in terms of complications and costs.