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. 2024 May 21;25(1):331.
doi: 10.1186/s13063-024-08132-7.

Implementation research: a protocol for two three-arm pragmatic randomised controlled trials on continuous glucose monitoring devices in people with type 1 diabetes in South Africa and Kenya

Elena Marbán-Castro  1 , Lorrein Muhwava  2 , Yvonne Kamau  2 , Elvis Safary  2 , Paul Rheeder  3 , Maria Karsas  3 , Tanja Kemp  3 , Johanè Freitas  3 , Michelle Carrihill  4 , Joel Dave  5 , Daniel Katambo  6 , Joan Kimetto  6 , Razana Allie  3 ; Kenya ACCEDE study group; South Africa ACCEDE study group; Joseph Ndungu  2 , Ntombi Sigwebela  2 , Dorcas Akach  2 , Sarah Girdwood  2 , Berra Erkosar  2 , Brooke E Nichols  2 , Cathy Haldane  2 , Beatrice Vetter  2 , Sonjelle Shilton  2
Collaborators, Affiliations

Implementation research: a protocol for two three-arm pragmatic randomised controlled trials on continuous glucose monitoring devices in people with type 1 diabetes in South Africa and Kenya

Elena Marbán-Castro et al. Trials. .

Abstract

Background: Self-monitoring of glucose is an essential component of type 1 diabetes (T1D) management. In recent years, continuous glucose monitoring (CGM) has provided an alternative to daily fingerstick testing for the optimisation of insulin dosing and general glucose management in people with T1D. While studies have been conducted to evaluate the impact of CGM on clinical outcomes in the US, Europe and Australia, there are limited data available for low- and middle-income countries (LMICs) and further empirical evidence is needed to inform policy decision around their use in these countries.

Methods: This trial was designed as a pragmatic, parallel-group, open-label, multicentre, three-arm, randomised (1:1:1) controlled trial of continuous or periodic CGM device use versus standard of care in people with T1D in South Africa and Kenya. The primary objective of this trial will be to assess the impact of continuous or periodic CGM device use on glycaemic control as measured by change from baseline glycosylated haemoglobin (HbA1c). Additional assessments will include clinical outcomes (glucose variation, time in/below/above range), safety (adverse events, hospitalisations), quality of life (EQ-5D, T1D distress score, Glucose Monitoring Satisfaction Survey for T1D), and health economic measures (incremental cost-effectiveness ratios, quality adjusted life years).

Discussion: This trial aims to address the substantial evidence gap on the impact of CGM device use on clinical outcomes in LMICs, specifically South Africa and Kenya. The trial results will provide evidence to inform policy and treatment decisions in these countries.

Trial registration: NCT05944731 (Kenya), July 6, 2023; NCT05944718 (South Africa), July 13, 2023.

Keywords: (3–10): glucose monitoring; CGM; Continuous glucose monitoring; Protocol; Randomised controlled trial; Standard of care; Type 1 diabetes.

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Conflict of interest statement

There are no competing interests to declare.

Figures

Fig. 1
Fig. 1
Study timeline schematic. *Enrolment is expected to take from 3 to 8 months. Q, quarter
See this image and copyright information in PMC

References

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