Using continuous glucose monitors for managing 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

This study is testing if using continuous glucose monitors can help people with Type 1 diabetes in South Africa manage their condition better compared to regular blood sugar checks.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 246 (estimated)
• Ages: 4 Years and up
• Sex: All
• Sponsor: Foundation for Innovative New Diagnostics, Switzerland (other)
• Locations: 3 sites (Pretoria, Gauteng and 2 other locations)
• Trial ID: NCT05944718 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of continuous glucose monitoring (CGM) devices among individuals with Type 1 diabetes in South Africa. It is designed as a three-arm pragmatic randomized control study, comparing continuous CGM use, intermittent CGM use, and standard self-monitoring of blood glucose (SMBG) over a period of 9 months. Participants will have regular clinic visits, and their HbA1c levels will be monitored to assess the impact of CGM on diabetes management. The study aims to integrate CGM into routine diabetes care to improve patient outcomes.

Who should consider this trial

Good fit: Ideal candidates include individuals living with Type 1 diabetes who have consistently high HbA1c levels of 10% or more.

Not a fit: Patients who are under 4 years old or have HbA1c levels below 10% may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly enhance glucose management and reduce complications for patients with Type 1 diabetes.

How similar studies have performed: Other studies have shown promising results with continuous glucose monitoring, indicating potential benefits in diabetes management.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Where this trial is running

Pretoria, Gauteng and 2 other locations

• Steve Biko Academic Hospital — Pretoria, Gauteng, South Africa (RECRUITING)
• Groote Schuur Hospital - Diabetes Centre — Cape Town, Western Cape, South Africa (RECRUITING)
• Red Cross Hospital — Cape Town, Western Cape, South Africa (RECRUITING)

Study contacts

• Study coordinator: Lorrein Muhwava

Conditions: Type 1 Diabetes, continuous glucose monitoring