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ACCEDE operational research study

Background

Diabetes mellitus (diabetes) is a widespread chronic condition that represents a major public health and clinical concern globally. Recent data shows that approximately 537 million adults (aged 20-79) are living with diabetes worldwide and this number is projected to rise, driven by factors such as aging populations, urbanization, and lifestyle changes. Efforts in prevention, early detection, and management are critical in addressing this growing public health challenge.

Self-monitoring of blood glucose (SMBG) is a critical part of the care of individuals with diabetes. SMBG entails capillary fingerstick blood glucose testing multiple times per day. Many people with diabetes find this testing painful and cumbersome, often resulting in poor compliance to a glucose self-monitoring schedule. Furthermore, SMBG only provides limited visibility on daily and nightly glucose profiles, meaning that hypo- and hyperglycaemic episodes can be missed or detected with delay.

The use of minimally invasive continuous glucose monitoring devices (CGMs) in diabetes management circumvents these challenges as CGMs measure glucose every few minutes over a period of 1-2 weeks or 3 months depending on the model, through a sensor with a fine needle that is inserted once into a user’s arm or abdomen. This enables periodic glucose measurement without repeat finger pricks and provides the user with a detailed glucose profile over the entire wear time of the sensor, thus enabling better adjustment of therapy or behaviour.

In populations where CGMs are accessible to people with diabetes as standard of care and without additional cost, many people with type 1 diabetes have switched from SMBG via fingerstick to the use of CGMs permanently, using the devices continuously. This is rarely possible for people with type 1 diabetes in the public sector in LMICs as CGMs are not provided as standard of care. Little data on the effectiveness, feasibility, acceptability, and cost of the use of CGMs in LMIC populations is available to inform clinical models for integrating CGMs into diabetes management.

This study is essential in evaluating various continuous glucose monitoring use cases in low-resource settings. Our goal is to generate critical data to improve diabetes care and outcomes for individuals with type 1 diabetes in South Africa, Kenya and beyond”

Dr Beatrice Vetter

ACCEDE Operational Research – South Africa

Trial registration:  [Pan African Clinical Trials Registry: PACTR202310817339585 | Clinicalstudys.gov: NCT 05944718]

This study aims to evaluate the clinical and cost-effectiveness, feasibility and acceptability of CGM use among people with type 1 diabetes in South Africa. It will also assess whether intermittent CGM use provides clinical benefits, a critical question in settings where continuous use may be unaffordable.

Project Timeline: 2023-2026

Start dates: South Africa: September 2023

Objectives

The ACCEDE Operational Research study will assess the impact of continuous and intermittent CGM use on blood glucose levels in comparison to the standard of care in people living with type 1 diabetes.

In addition, we will assess the impact of continuous and intermittent CGM use on the variability of blood glucose concentrations related to diabetes, unplanned visits to outpatient clinics and/or hospital related to diabetes complications, quality of life of recipients of diabetes care and their caregivers (where applicable) as well as the acceptability, feasibility and cost of continuous and intermittent CGM use.

Outcomes

This study seeks to generate robust evidence on the clinical effectiveness and health economic impact of CGM use in LMICs, specifically in South Africa. Findings from the trial will inform national policy, clinical guidelines, and resource allocation decisions related to diabetes management in this setting.

Partners & Collaborators

  • South Africa
  • Steve Biko Academic Hospital, University of Pretoria
  • Groote Schuur Hospital – Diabetes Centre, University of Cape Town
  • Red Cross War Memorial Children’s Hospital, University of Cape Town

       

      ACCEDE Operational Research – Kenya

      ACCEDE Usability (ACCEDE U) Study

      In Kenya, the ACCEDE U study is being implemented as a three-month usability study at Kenyatta National Hospital (KNH) to assess the use of continuous glucose monitoring (CGM) devices among young people living with type 1 diabetes (T1D).

      A total of 40 participants attending KNH, under the age of 25, will be included in the study and use CGMs continuously over a three-month period.

      The study aims to assess the usability, feasibility, acceptability and cost of CGM by persons living with T1D, health care providers (HCPs) and caregivers at KNH paediatric and adolescent endocrinology clinic.

      Objectives

      To assess the usability of CGM by persons living with T1D, HCPs and caregivers.

      Outcomes

      The main outcome of this study would be the system usability scale (SUS) scores from CGM users at the end point.

      Findings will inform future efforts to integrate CGMs into Kenya’s national diabetes care programs, with particular attention to CGM use as an acceptable and feasible option for people living with T1D.

      Project Timeline: 2025-2026

      Partners & Collaborators

      • Kenya
      • Kenyatta National Hospital Team

      Partners & Collaborators

       

      South Africa

      Steve Biko Academic Hospital, University of Pretoria
      Prof. Paul Rheeder,
      Principal Investigator
      Dr Maria Karsas,
      Co-Principal Investigator
      Dr Tanja Kemp,
      Investigator
      Dr Johane Freitas,
      Investigator
      Ms Razana Allie,
      Diabetes Specialist Nurse
      Ms Cleon Lekabe,
      Research Assistant
      Ms Mary-Jane van Zyl,
      Research Assistant
      Groote Schuur Hospital – Diabetes Centre, University of Cape Town
      Prof. Joel Dave
      Principal
      Investigator
      Prof. Ian Ross
      Co-Investigator
      Dr William Toet
      Co-Investigator
      Dr Sophie Davies- Van Es
      Co-Investigator
      Dr Melanie Moyo
      Study Physician
      Dr Maleeka Abrahams-Kahaar
      Co-Investigator
      Dr Hanadi Alganeeb
      Co-Investigator
      Ms Buyelwa Majikela-Dlangamandla
      Diabetes Nurse Educator
      Mr Neil Meiring
      Diabetes Nurse Educator
      Ms Tyamkazi Nqekeza
      Diabetes Nurse Educator
      Ms Lisa van Wyk
      Research Assistant
      Red Cross War Memorial Children’s Hospital, University of Cape Town
      Dr Michelle Carrihill
      Principal Investigator
      Dr Wayne S. Rajah
      Medical Doctor
      Dr Amith Ramcharan
      Medical Doctor
      Dr Deepika Goolab
      Medical Doctor
      Sr Laura Symmonds
      Diabetes Nurse Educator
      Sr Lindi Gqamana
      Diabetes Nurse Educator
      Sr Santie Horn
      Diabetes Nurse Educator
      Dr Lindsay Rajah
      Research Coordinator

      Kenya

      Kenyatta National Hospital
      Dr Prisca Amolo
      Principal Investigator
      Dr. Lucy Mungai
      Co-Investigator
      Dr. Agnes Karingo
      Co-Investigator
      Emmaculate Nzove
      Project manager

      FIND

      FIND ACCEDE Team
      Dr Lorrein Muhwava
      Scientist, NCD Programme
      Dr Yvonne Kamau
      Scientist, NCD Programme
      Dr Elena Marban
      Scientist
      Dr Anjana Tomar
      Clinical Trials Manager
      Vincent Fiechter
      Sarah Girdwood
      Michael Otieno
      Clinical Data Manager
      Cathy Haldane
      Head of NCD Programme
      Vincent Fiechter
      Senior Project Manager
      Sarah Girdwoord
      Health Economist

      Past ACCEDE Team
      Dr Beatrice Vetter
      Director, NCD Programme
      Sonjelle Shilton
      Deputy Director,
      Operational & Implementation Research
      Dr Juvenal Nkeramahame
      Clinical Trials Manager
      Dorcas Akach
      Clinical Data Manager

      People living with type 1 diabetes in lower- and middle-income countries deserve access to the same quality care as those in high-income countries. By making continuous glucose monitoring devices accessible in Kenya and South Africa, the ACCEDE project is paving the way to deliver the highest standard of care to everyone.

      Gina Agiostratidou

      T1D Program Director at the Helmsley Charitable Trust

      Publications

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      Scientific article  (PDF, 1.02 MB, 13 pages)

      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

      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.

      Elena Marbán-Castro, et al.
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      Scientific article  (PDF, 455.82 KB, 10 pages)

      Use of continuous glucose monitors in low-and middle-income countries: a scoping review

      The scoping review identified that studies about CGMs in LMICs have several limitations. Stronger study designs, appropriate sample sizes and the inclusion of patient-important outcomes should be considered to inform the evidence about CGMs for the management of people with diabetes in LMICs.

      Antonio Barnabe-Ortiz, et al.

        Contact the ACCEDE team

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        Funding

        This research is funded through a grant from The Leona M. and Harry B. Helmsley Charitable Trust.