NCT05944718Completed
Use of Continuous Glucose Monitoring Devices Among People Living With Type 1 Diabetes in South Africa
Three-arm Pragmatic Randomized Study on the Effectiveness, Feasibility, Acceptability, and Cost of the Use of Continuous Glucose Monitoring Devices Among People Living With Type 1 Diabetes in South Africa
Source: ClinicalTrials.gov · Last updated 12 Aug 2025
Brief summary (registry, in English)
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 South Africa.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 246 (actual)
- First submitted
- 19 Jun 2023
- Start date
- 11 Sept 2023
- Primary completion date
- 31 Jul 2025
- Lead sponsor
- Foundation for Innovative New Diagnostics, Switzerland
- Diseases
- Type 1 diabetes
- NCT number
- NCT05944718
What you commit to
- Study type: Interventional
- Participants enrolled: 246
- From 11 Sept 2023 to the primary completion date, 31 Jul 2025
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants are excluded from the Study if any of the following exclusion criteria apply:
- People living with T1 diabetes under 4 years old as this the minimum age for use of CGM as per the CGMs used in this study manufacturer instructions.
- People diagnosed with T1 diabetes within the last 2 years.
- People who have used a CGM in the last 6 months prior to enrollment.
- People who anticipate that they would have access to a CGM through means outside this study during the duration of the study (15 months).
- People living with Type 2 diabetes.
- Known pregnancy at the time of study enrolment.
- People who are not willing to agree to Freestyle Libre T\&Cs
Who the study is looking for
- Recipient of care participants are eligible to be included in the Study only if all the following inclusion criteria apply:
- People living with T1 diabetes with HbA1c current levels ≥10% within the last 3 months (and at least 2 HbA1c ≥10% within the last 18 months prior to study enrolment) who are attending for diabetes care at the 3 study clinics.
- Care givers to children/adolescents living with T1 diabetes are eligible to be included in the study only if all the following inclusion criteria apply:
- The child/adolescent that the person is a care giver to is enrolled in the study.
- Healthcare providers are eligible to be included in the study only if all the following inclusion criteria apply:
- Healthcare provider at the study sties engaged in diabetes care provision related to the study.
Age in the registry: 4 years to - · Sex: All · Accepts healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Red Cross Hospital Coordinator of this site? Confirm its status | Cape Town | South Africa | Unknown status |
| Groote Schuur Hospital - Diabetes Centre Coordinator of this site? Confirm its status | Cape Town | South Africa | Unknown status |
| Steve Biko Academic Hospital Coordinator of this site? Confirm its status | Pretoria | South Africa | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.