NCT05944731: ACCEDE

Use of Continuous Glucose Monitoring Devices Among People Living With Type 1 Diabetes in Kenya.

Status unknown NA Last updated 22 November 2023

What this trial tests

NA trial testing Continuous glucose monitor in Type 1 Diabetes in 246 participants. Status unknown.

Timeline

5 February 2024

Primary endpoint
30 November 2024

28 April 2025

Quick facts

Lead sponsor	Foundation for Innovative New Diagnostics, Switzerland
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	246
Start date	5 February 2024
Primary completion	30 November 2024
Estimated completion	28 April 2025

Drugs / interventions tested

• Continuous glucose monitor

Conditions studied

• Type 1 Diabetes — all drugs for Type 1 Diabetes →

Sponsor

Foundation for Innovative New Diagnostics, Switzerland

Who can join

4 and older, any sex, with Type 1 Diabetes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Diabetes mellitus (diabetes) is a chronic condition that represents a major public health and clinical concern. 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 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 possibly for people with type 1 diabetes in the public sector in LMICs as CGMs are not provided as standard of care. Little data on effectiveness, feasibility, acceptability, and cost of the use of CGMs in LMIC populations is available to inform clinical models for the integration of CGMs into diabetes management. Furthermore, it has not been investigated if intermittent, as opposed to continuous use of CGMs provides clinical benefit. Intermittent use could be beneficial for people with diabetes who do not have the means to pay for continuous use of CGMs.

This study aims to evaluate the effectiveness, feasibility, acceptability, and cost of intermittent and continuous use of CGM among people with type 1 diabetes in Kenya.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. 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 E, Muhwava L, Kamau Y, Safary E, et al · · 2024 · PMID 38773658 · DOI 10.1186/s13063-024-08132-7