Use of continuous glucose monitoring devices among people living with type 1 diabetes in South Africa

Use of continuous glucose monitoring devices among people living with type 1 diabetes in South Africa: A three-arm pragmatic randomized study on the effectiveness, feasibility, acceptability, and cost.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

PACTR

Registry ID

PACTR202310817339585

Enrollment

246

Registered

2023-10-05

Start date

2023-09-04

Completion date

Unknown

Last updated

2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nutritional, Metabolic, Endocrine

Interventions

Continuous Glucose Monitoring Devices

No intervention

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Recipients of Care eligibility criteria: People living with type 1 diabetes with current HbA1c levels =10% / >86mmol/mol (and for at least 2 measurements over 18 months) attending for diabetes care at the 3 sites. Health care providers eligibility criteria: Healthcare providers at the study sites engaged in diabetes care provision related to the study

Exclusion criteria

Exclusion criteria: Recipients of Care exclusion criteria: • People living with type 1 diabetes under 4 years of age. • People diagnosed with type 1 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 time of enrolment.

Design outcomes

Primary

Measure	Time frame
1.Comparison of the magnitude of change in HbA1c levels (expressed as a percentage and in mmol/mol) before and after treatment in standard of care, continuous and intermittent CGM arms	—

Secondary

Measure	Time frame
2. Estimates of coefficient of variation (CV) for glucose concentrations with 95% confidence intervals, Time in Range (TIR), Time Below Range (TBR), and Time Above Range (TAR) (percentage of time per day and as estimated hours and minutes per day with their 95% confidence intervals) for participants who received the CGM treatments. 3. Number of hospitalizations related to diabetes complications per each group, represented by means and standard deviations. 4. Mixed methods Quality of Life (QoL): A: survey results including EQ-5D-Y/EQ-5D and Diabetes distress scores at baseline, midpoint, end point of intervention and endpoint of study. B: Qualitative methods (FGD) among recipients of care and their caregivers 5. Mixed methods: Feasibility will be assessed based on Arm 1 and Arm 2 adherence to protocol in terms of CGM use. Acceptability scores from the GMSS tool at baseline, midline, and end of the intervention period among recipients of care, and results from an acceptability survey from baseline, midline, and endline among recipients of care and their caregivers. Qualitative methods: SSI among health care providers involved in clinical care at the study sites. 6. Costing surveys which capture direct and indirect costs at each follow-up visit among recipients of care, their caregivers and healthcare providers, and at end point of study, modelling over time horizon may be explored.	—

Measure

Time frame

2. Estimates of coefficient of variation (CV) for glucose concentrations with 95% confidence intervals, Time in Range (TIR), Time Below Range (TBR), and Time Above Range (TAR) (percentage of time per day and as estimated hours and minutes per day with their 95% confidence intervals) for participants who received the CGM treatments. 3. Number of hospitalizations related to diabetes complications per each group, represented by means and standard deviations. 4. Mixed methods Quality of Life (QoL): A: survey results including EQ-5D-Y/EQ-5D and Diabetes distress scores at baseline, midpoint, end point of intervention and endpoint of study. B: Qualitative methods (FGD) among recipients of care and their caregivers 5. Mixed methods: Feasibility will be assessed based on Arm 1 and Arm 2 adherence to protocol in terms of CGM use. Acceptability scores from the GMSS tool at baseline, midline, and end of the intervention period among recipients of care, and results from an acceptability survey from baseline, midline, and endline among recipients of care and their caregivers. Qualitative methods: SSI among health care providers involved in clinical care at the study sites. 6. Costing surveys which capture direct and indirect costs at each follow-up visit among recipients of care, their caregivers and healthcare providers, and at end point of study, modelling over time horizon may be explored.

—

Countries

South Africa

Contacts

Public ContactBeatrice Vetter

Director Non Communicable Diseases

Beatrice.Vetter@finddx.org+41077478118

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Feb 4, 2026