Use of Continuous Glucose Monitoring Devices Among People Living With Type 1 Diabetes in South Africa

NCT05944718 | Completed

• 1 other identifier: NC008
• Study Type: interventional
• Target: 246
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Type 1 Diabetes

Keywords

continuous glucose monitoring

Outcome Measures

Primary Outcomes (1)

• Impact of continuous and intermittent CGM use on blood glucose levels in comparison to standard of care in people living with type 1 diabetes

  Comparison of the magnitude of change in HbA1c levels before and after treatment in standard of care, continuous, and intermittent CGM arms

  15 months

Secondary Outcomes (11)

• 1a. Impact of continuous and intermittent CGM use on the variability of blood glucose concentrations related to diabetes.

  15 months

• 1b. Impact of continuous and intermittent CGM use on the variability of blood glucose concentrations related to diabetes.

  15 months

• 1c.Impact of continuous and intermittent CGM use on the variability of blood glucose concentrations related to diabetes.

  15 months

• 1d. Impact of continuous and intermittent CGM use on the variability of blood glucose concentrations related to diabetes.

  15 months

• 2. Impact of continuous and intermittent CGM use on unplanned visits to outpatient clinics and/or hospital related to diabetes complications.

  15 months

Study Arms (3)

Arm 1

EXPERIMENTAL

Arm 1 is those participants randomized to use of CGM in a continuous fashion; CGM use for the duration of 9 months.

Device: Continuous glucose monitor

Arm 2

EXPERIMENTAL

Arm 2 is those participants randomized to intermittent use of CGM; CGM use for 4 time points consisting of 2 weeks of CGM use each, for the duration of 9 months.

Device: Continuous glucose monitor

Arm 3

NO INTERVENTION

Arm 3 is those participants randomized to standard of care; regular use of self-monitoring of blood glucose (SMBG) for the duration of 9 months.

Interventions

Continuous glucose monitor DEVICE

Continuous Glucose Monitoring (CGM) is a technology used to measure glucose levels in people with diabetes. Unlike traditional finger prick self-monitoring of blood glucose (SMBG), CGM devices provide continuous and real-time glucose readings throughout the day and night. CGM systems consist of a small sensor that is inserted under the skin to measure glucose levels in the interstitial fluid, a transmitter that sends the glucose data to a receiver or smartphone, which shows the glucose readings. The sensor measures glucose levels automatically at regular intervals, eliminating the need for frequent finger pricks. CGM devices can track glucose trends, identify high or low glucose levels, and provide alerts for hypo- or hyperglycemia. This can help individuals make more informed decisions regarding their diabetes management, such as adjusting insulin doses, dietary choices, or physical activity levels.

Also known as: Freestyle Libre Abbott

Arm 1; Arm 2

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• The child/adolescent that the person is a care giver to is enrolled in the study.
• Healthcare provider at the study sties engaged in diabetes care provision related to the study.

You may not qualify if:

• 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

Sponsors & Collaborators

• Foundation for Innovative New Diagnostics, Switzerland: lead
• The Leona M. and Harry B. Helmsley Charitable Trust: collaborator
• University of Pretoria: collaborator
• University of Cape Town: collaborator

Study Sites (3)

Steve Biko Academic Hospital

Pretoria, Gauteng, 0007, South Africa

Location

Groote Schuur Hospital - Diabetes Centre

Cape Town, Western Cape, South Africa

Location

Red Cross Hospital

Cape Town, Western Cape, South Africa

Location

Related Publications (16)

• Maiorino MI, Signoriello S, Maio A, Chiodini P, Bellastella G, Scappaticcio L, Longo M, Giugliano D, Esposito K. Effects of Continuous Glucose Monitoring on Metrics of Glycemic Control in Diabetes: A Systematic Review With Meta-analysis of Randomized Controlled Trials. Diabetes Care. 2020 May;43(5):1146-1156. doi: 10.2337/dc19-1459.

  PMID: 32312858 BACKGROUND

• Lind M, Polonsky W, Hirsch IB, Heise T, Bolinder J, Dahlqvist S, Schwarz E, Olafsdottir AF, Frid A, Wedel H, Ahlen E, Nystrom T, Hellman J. Continuous Glucose Monitoring vs Conventional Therapy for Glycemic Control in Adults With Type 1 Diabetes Treated With Multiple Daily Insulin Injections: The GOLD Randomized Clinical Trial. JAMA. 2017 Jan 24;317(4):379-387. doi: 10.1001/jama.2016.19976.

  PMID: 28118454 BACKGROUND

• Beck RW, Riddlesworth T, Ruedy K, Ahmann A, Bergenstal R, Haller S, Kollman C, Kruger D, McGill JB, Polonsky W, Toschi E, Wolpert H, Price D; DIAMOND Study Group. Effect of Continuous Glucose Monitoring on Glycemic Control in Adults With Type 1 Diabetes Using Insulin Injections: The DIAMOND Randomized Clinical Trial. JAMA. 2017 Jan 24;317(4):371-378. doi: 10.1001/jama.2016.19975.

  PMID: 28118453 BACKGROUND

• Welsh JB, Gao P, Derdzinski M, Puhr S, Johnson TK, Walker TC, Graham C. Accuracy, Utilization, and Effectiveness Comparisons of Different Continuous Glucose Monitoring Systems. Diabetes Technol Ther. 2019 Mar;21(3):128-132. doi: 10.1089/dia.2018.0374. Epub 2019 Jan 25.

  PMID: 30681379 BACKGROUND

• Brown JVE, Ajjan R, Siddiqi N, Coventry PA. Acceptability and feasibility of continuous glucose monitoring in people with diabetes: protocol for a mixed-methods systematic review of quantitative and qualitative evidence. Syst Rev. 2022 Dec 9;11(1):263. doi: 10.1186/s13643-022-02126-9.

  PMID: 36494845 BACKGROUND

• Distiller LA, Cranston I, Mazze R. First Clinical Experience with Retrospective Flash Glucose Monitoring (FGM) Analysis in South Africa: Characterizing Glycemic Control with Ambulatory Glucose Profile. J Diabetes Sci Technol. 2016 Nov 1;10(6):1294-1302. doi: 10.1177/1932296816648165. Print 2016 Nov.

  PMID: 27154973 BACKGROUND

• Wells, R. and Knowles, A., 2023. The psychological and health benefits of using a continuous glucose monitor for a person with type 1 diabetes: A South African higher education context. F1000Research, 12(373), p.373.

  BACKGROUND

• van Heerden, A., Kolozali, Ş. and Norris, S.A., 2022. Feasibility and acceptability of continuous at-home glucose monitoring during pregnancy: a mixed-methods pilot study. South African Journal of Clinical Nutrition, pp.1-8.

  BACKGROUND

• Gamerman, V., Cai, T. and Elsäßer, A., 2019. Pragmatic randomized clinical trials: best practices and statistical guidance. Health Services and Outcomes Research Methodology, 19, pp.23-35.

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• Loudon K, Treweek S, Sullivan F, Donnan P, Thorpe KE, Zwarenstein M. The PRECIS-2 tool: designing trials that are fit for purpose. BMJ. 2015 May 8;350:h2147. doi: 10.1136/bmj.h2147. No abstract available.

  PMID: 25956159 BACKGROUND

• Cohen, J., 1988. Statistical power analysis for the behavioral sciences (2nd ed.). Hillsdale, NJ: Erlbaum.

  BACKGROUND

• Faul F, Erdfelder E, Buchner A, Lang AG. Statistical power analyses using G*Power 3.1: tests for correlation and regression analyses. Behav Res Methods. 2009 Nov;41(4):1149-60. doi: 10.3758/BRM.41.4.1149.

  PMID: 19897823 BACKGROUND

• Bowen, G.A., 2008. Naturalistic inquiry and the saturation concept: a research note. Qualitative research, 8(1), pp.137-152.

  BACKGROUND

• Marban-Castro E, Muhwava L, Kamau Y, Safary E, Rheeder P, Karsas M, Kemp T, Freitas J, Carrihill M, Dave J, Katambo D, Kimetto J, Allie R; Kenya ACCEDE study group; South Africa ACCEDE study group; Ndungu J, Sigwebela N, Akach D, Girdwood S, Erkosar B, Nichols BE, Haldane C, Vetter B, Shilton S. 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. Trials. 2024 May 21;25(1):331. doi: 10.1186/s13063-024-08132-7.

  PMID: 38773658 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Beatrice Vetter

  Find

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Three arm pragmatic randomized controlled study Arm 1: use of CGM in a continuous manner from enrolment to the end of intervention period Arm 2: intermittent use of CGM (use for 2 weeks once every three months) from enrolment to the end of intervention period Arm 3 (control): standard of care

Study Record Dates

• First Submitted: June 19, 2023
• First Posted: July 13, 2023
• Study Start: September 11, 2023
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (3)