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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.
Marbán-Castro, Elena; Muhwava, Lorrein; Kamau, Yvonne; Safary, Elvis; Rheeder, Paul; Karsas, Maria; Kemp, Tanja; Freitas, Johanè; Carrihill, Michelle; Dave, Joel; Katambo, Daniel; Kimetto, Joan; Allie, Razana; Ndungu, Joseph; Sigwebela, Ntombi; Akach, Dorcas; Girdwood, Sarah; Erkosar, Berra; Nichols, Brooke E; Haldane, Cathy; Vetter, Beatrice; Shilton, Sonjelle.
Afiliación
  • Marbán-Castro E; FIND, Campus Biotech, Chemin Des Mines 9, 1202, Geneva, Switzerland. elena.marban@finddx.org.
  • Muhwava L; FIND, Campus Biotech, Chemin Des Mines 9, 1202, Geneva, Switzerland.
  • Kamau Y; FIND, Campus Biotech, Chemin Des Mines 9, 1202, Geneva, Switzerland.
  • Safary E; FIND, Campus Biotech, Chemin Des Mines 9, 1202, Geneva, Switzerland.
  • Rheeder P; University of Pretoria Diabetes Research Centre, Gezina, Pretoria, South Africa.
  • Karsas M; University of Pretoria Diabetes Research Centre, Gezina, Pretoria, South Africa.
  • Kemp T; University of Pretoria Diabetes Research Centre, Gezina, Pretoria, South Africa.
  • Freitas J; University of Pretoria Diabetes Research Centre, Gezina, Pretoria, South Africa.
  • Carrihill M; Red Cross Childrens Hospital, Paediatric Clinic, Cape Town, South Africa.
  • Dave J; Division of Endocrinology, Groote Schuur Hospital and the University of Cape Town, Cape Town, South Africa.
  • Katambo D; Kenya Diabetes Management and Information Centre, Nairobi, Kenya.
  • Kimetto J; Kenya Diabetes Management and Information Centre, Nairobi, Kenya.
  • Allie R; University of Pretoria Diabetes Research Centre, Gezina, Pretoria, South Africa.
  • Ndungu J; FIND, Campus Biotech, Chemin Des Mines 9, 1202, Geneva, Switzerland.
  • Sigwebela N; FIND, Campus Biotech, Chemin Des Mines 9, 1202, Geneva, Switzerland.
  • Akach D; FIND, Campus Biotech, Chemin Des Mines 9, 1202, Geneva, Switzerland.
  • Girdwood S; FIND, Campus Biotech, Chemin Des Mines 9, 1202, Geneva, Switzerland.
  • Erkosar B; FIND, Campus Biotech, Chemin Des Mines 9, 1202, Geneva, Switzerland.
  • Nichols BE; FIND, Campus Biotech, Chemin Des Mines 9, 1202, Geneva, Switzerland.
  • Haldane C; FIND, Campus Biotech, Chemin Des Mines 9, 1202, Geneva, Switzerland.
  • Vetter B; FIND, Campus Biotech, Chemin Des Mines 9, 1202, Geneva, Switzerland.
  • Shilton S; FIND, Campus Biotech, Chemin Des Mines 9, 1202, Geneva, Switzerland.
Trials ; 25(1): 331, 2024 May 21.
Article en En | MEDLINE | ID: mdl-38773658
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 (111) 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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Hemoglobina Glucada / Diabetes Mellitus Tipo 1 Límite: Humans País/Región como asunto: Africa Idioma: En Revista: Trials Asunto de la revista: MEDICINA / TERAPEUTICA Año: 2024 Tipo del documento: Article País de afiliación: Suiza Pais de publicación: Reino Unido
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Hemoglobina Glucada / Diabetes Mellitus Tipo 1 Límite: Humans País/Región como asunto: Africa Idioma: En Revista: Trials Asunto de la revista: MEDICINA / TERAPEUTICA Año: 2024 Tipo del documento: Article País de afiliación: Suiza Pais de publicación: Reino Unido