Use of Continuous Glucose Monitoring Devices Among People Living With Type 1 Diabetes in South Africa (ACCEDE)
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ClinicalTrials.gov Identifier: NCT05944718 |
Recruitment Status :
Recruiting
First Posted : July 13, 2023
Last Update Posted : April 23, 2024
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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.
Condition or disease | Intervention/treatment | Phase |
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Type 1 Diabetes | Device: Continuous glucose monitor | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 246 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | 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 |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | 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 |
Actual Study Start Date : | September 11, 2023 |
Estimated Primary Completion Date : | November 30, 2024 |
Estimated Study Completion Date : | February 28, 2025 |
Arm | Intervention/treatment |
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Experimental: Arm 1
Arm 1 is those participants randomized to use of CGM in a continuous fashion; CGM use for the duration of 9 months.
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Device: Continuous glucose monitor
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. Other Name: Freestyle Libre Abbott |
Experimental: Arm 2
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.
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Device: Continuous glucose monitor
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. Other Name: Freestyle Libre Abbott |
No Intervention: Arm 3
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.
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- Impact of continuous and intermittent CGM use on blood glucose levels in comparison to standard of care in people living with type 1 diabetes [ Time Frame: 15 months ]Comparison of the magnitude of change in HbA1c levels before and after treatment in standard of care, continuous, and intermittent CGM arms
- 1a. Impact of continuous and intermittent CGM use on the variability of blood glucose concentrations related to diabetes. [ Time Frame: 15 months ]Estimates of coefficient of variation (CV) for glucose concentrations with 95% confidence intervals, for participants who received the CGM treatments.
- 1b. Impact of continuous and intermittent CGM use on the variability of blood glucose concentrations related to diabetes. [ Time Frame: 15 months ]Estimates Time in Range (TIR) with 95% confidence intervals for participants who received the CGM treatments.
- 1c.Impact of continuous and intermittent CGM use on the variability of blood glucose concentrations related to diabetes. [ Time Frame: 15 months ]Estimates Time Below Range (TBR) with 95% confidence intervals for participants who received the CGM treatments.
- 1d. Impact of continuous and intermittent CGM use on the variability of blood glucose concentrations related to diabetes. [ Time Frame: 15 months ]Estimates Time Above Range (TAR) with 95% confidence intervals for participants who received the CGM treatments.
- 2. Impact of continuous and intermittent CGM use on unplanned visits to outpatient clinics and/or hospital related to diabetes complications. [ Time Frame: 15 months ]Number of hospitalizations related to diabetes complications per each group, represented by means and standard deviations.
- 3a. Impact of continuous and intermittent CGM use on quality of life of recipients of diabetes care and their caregivers (where applicable) [ Time Frame: 15 months ]Mixed methods 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.
- 3b. Impact of continuous and intermittent CGM use on quality of life of recipients of diabetes care and their caregivers (where applicable) [ Time Frame: 15 months ]Mixed methods : Qualitative methods FGD among recipients of care and their caregivers
- 4a. Acceptability and feasibility of continuous and intermittent CGM use from a healthcare provider, recipients of care and care givers perspective. [ Time Frame: 15 months ]Mixed methods: Feasibility will be assessed based on Arm 1 and Arm 2 adherence to protocol in terms of CGM use.
- 4b.Acceptability and feasibility of continuous and intermittent CGM use from a healthcare provider, recipients of care and care givers perspective. [ Time Frame: 15 months ]survey from baseline, midline, and endline among recipients of care and their caregivers.
- 4c. Acceptability and feasibility of continuous and intermittent CGM use from a healthcare provider, recipients of care and care givers perspective. [ Time Frame: 15 months ]Mixed methods: Qualitative methods: SSI among health care providers involved in clinical care at the study sites.
- 5. Cost of continuous and intermittent CGM use from a user and provider perspective [ Time Frame: 15 months ]Costing surveys which capture direct and indirect costs at each follow-up visit among recipients of care, their caregivers and healthcare provider, and at end point of study, modelling over time horizon may be explored.
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Ages Eligible for Study: | 4 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.
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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.
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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:
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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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05944718
Contact: Lorrein Muhwava | +27730346103 | lorrein.muhwava@finddx.org | |
Contact: Cathy Haldane | +27823726496 | Cathy.Haldane@finddx.org |
South Africa | |
Steve Biko Academic Hospital | Recruiting |
Pretoria, Gauteng, South Africa, 0007 | |
Contact: Paul Rheeder, Prof +27123543861 paul.rheeder@up.ac.za | |
Contact: Maria Karsas, Dr | |
Groote Schuur Hospital - Diabetes Centre | Recruiting |
Cape Town, Western Cape, South Africa | |
Contact: Joel Dave, Prof joeldave@endocrine.co.za | |
Contact: Lisa van Wyk, Ms ACCEDE.GSH@finddx.org | |
Red Cross Hospital | Recruiting |
Cape Town, Western Cape, South Africa | |
Contact: Michelle Carrihill, Dr michelle.carrihill@uct.ac.za | |
Contact: Lindsay Rajah, Dr ACCEDE.Redcross@finddx.org |
Study Director: | Beatrice Vetter | Find |
Responsible Party: | Foundation for Innovative New Diagnostics, Switzerland |
ClinicalTrials.gov Identifier: | NCT05944718 |
Other Study ID Numbers: |
NC008 |
First Posted: | July 13, 2023 Key Record Dates |
Last Update Posted: | April 23, 2024 |
Last Verified: | April 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
continuous glucose monitoring |
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Autoimmune Diseases Immune System Diseases |