| Protocol No: | ECCT/25/08/07 | Date of Protocol: | 02-06-2025 |
| Study Title: | USABILITY, ACCEPTABILITY, FEASIBILITY AND COST OF CONTINUOUS GLUCOSE MONITORING BY PERSONS LIVING WITH TYPE 1 DIABETES MELLITUS, HEALTH CARE PROVIDERS AND CAREGIVERS AT THE PAEDIATRIC AND ADOLESCENT ENDOCRINOLOGY CLINIC IN KENYATTA NATIONAL HOSPITAL |
| Study Objectives: | Main ObjectiveTo assess the usability, feasibility, acceptability and cost of CGM by persons living with type 1 diabetes mellitus, health care providers and caregivers at the Kenyatta National Hospital paediatric and adolescent endocrinology clinic. Primary Objective
Secondary Objectives
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| Laymans Summary: | Managing type 1 diabetes usually requires people to check their blood sugar regularly using finger-prick tests. While important, this method can be painful, inconvenient, and doesn't always show how blood sugar changes throughout the day. Continuous glucose monitoring (CGM) devices offer a better option. These small devices measure blood sugar continuously and more comfortably, helping people manage their diabetes more effectively. However, in countries like Kenya, CGMs are not widely used, and there is little information about how suitable and affordable they are in these settings. This study aims to understand whether CGM devices can work well for children and young adults with type 1 diabetes in Kenya. It will be conducted at Kenyatta National Hospital and will involve 40 participants with diabetes (aged 4–25), as well as their caregivers and healthcare workers. Participants will use a CGM device for three months. During this time, they will attend two clinic visits and receive education on how to use the device. The study will collect feedback on how easy the devices are to use, whether people are willing to use them long-term, and how the devices affect their quality of life and blood sugar control. Focus group discussions and interviews will also be held to learn more about their experiences. The findings will help understand whether CGM is practical, acceptable, and cost-effective in Kenya. The results may also help guide national health decisions, such as including CGMs in the list of essential diabetes care products. |
| Abstract of Study: | Study Background: Self-monitoring of blood glucose (SMBG) is integral to diabetes management but is associated with challenges such as pain, inconvenience, and limited ability to capture fluctuations in glucose levels. Continuous glucose monitoring (CGM) devices offer a solution by providing real-time, minimally invasive glucose measurements, thereby facilitating better diabetes management. However, in low- and middle-income countries (LMICs), CGMs are not routinely available, and data on their usability, feasibility, acceptability, and cost in these settings remain limited. This study aims to assess the continuous use of CGM among people with type 1 diabetes in Kenya, focusing on these key parameters. Objectives: The purpose of this study is to assess the usability, acceptability, feasibility and cost of CGM use among people living with type 1 diabetes (PLWDM), healthcare providers, and caregivers at Kenyatta National Hospital. Methodology: This prospective mixed methods study will be carried out at the Kenyatta National Hospital in Nairobi, Kenya. It will include persons aged 4-25 years with type 1 diabetes mellitus (T1DM), their caregivers and healthcare workers (HCW) who provide care to these patients and have consented or assented as appropriate. A sample size of 40 will be targeted for the persons living with T1DM and 5 to 10 for the healthcare workers. Participants will use CGM devices continuously for three months between clinic visits and receive an educational session. Structured questionnaires will be employed to assess participant experiences at enrolment (baseline) and month 3 (endline). Focus Group Discussions (FGDs) will be scheduled after CGM use. Semi-structured interviews (SSIs) will be scheduled with HCWs after CGM data interpretation at month 3. Severe adverse events (SAEs) will be monitored. Clinical visits at baseline and endline will involve a review of CGM data, education session and completion of study surveys. Data Analysis: Descriptive statistical methods will be applied to analyze usability scores (SUS), acceptability, quality of life, diabetes distress scores, and HbA1c levels. Estimates of glucose variability will be calculated using the coefficient of variation (CV) formula (SD/mean), with 95% confidence intervals computed. Comparative analysis on the magnitude of change in HbA1c levels at baseline and endline will be done to assess the impact of CGM use in study participants. Study Utility: This study will provide information on the usability, acceptability, feasibility, and cost of CGM. The data from this research will be presented to the policymakers who can avail the resources and have CGM devices included in the essential medicines list.
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