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Clinical Trial NCT05944718 (ACCEDE) for Type 1 Diabetes is completed. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Use of Continuous Glucose Monitoring Devices Among People Living With Type 1 Diabetes in South Africa (ACCEDE) 246
Clinical Trial NCT05944718 (ACCEDE) was an interventional study for Type 1 Diabetes that is now completed. The study started on 11 September 2023, with plans to enroll 246 participants. Led by Foundation for Innovative New Diagnostics, Switzerland, the expected completion date was 31 July 2025. The latest data from ClinicalTrials.gov was last updated on 12 August 2025.
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-monit...Show More
Detailed Description
3 Study Design As this study is a PrCT the study aspects will be embedded in the normal clinical care delivery of diabetes care in the selected clinics (see section 3.2, Scientific Rational for Selection of Study Design). Introducing only 1 additional clinic visit and 1 additional qualitative visit for study related procedures. The primary outcome measure, HbA1c, will be assessed through the HbA1c testing that is alr...Show More
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
Conditions
Type 1 DiabetesPublications
Scientific articles and research papers published about this clinical trial:Other Study IDs
- ACCEDE
- NC008
NCT ID Number
Start Date (Actual)
2023-09-11
Last Update Posted
2025-08-12
Completion Date (Estimated)
2025-07-31
Enrollment (Estimated)
246
Study Type
Interventional
PHASE
N/A
Status
Completed
Keywords
continuous glucose monitoring
Primary Purpose
Diagnostic
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalArm 1 Arm 1 is those participants randomized to use of CGM in a continuous fashion; CGM use for the duration of 9 months. | 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 send...Show More |
ExperimentalArm 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. | 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 send...Show More |
No InterventionArm 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. | N/A |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
1a. Impact of continuous and intermittent CGM use on the variability of blood glucose concentrations related to diabetes. | Estimates of coefficient of variation (CV) for glucose concentrations with 95% confidence intervals, for participants who received the CGM treatments. | 15 months |
1b. Impact of continuous and intermittent CGM use on the variability of blood glucose concentrations related to diabetes. | Estimates Time in Range (TIR) with 95% confidence intervals for participants who received the CGM treatments. | 15 months |
1c.Impact of continuous and intermittent CGM use on the variability of blood glucose concentrations related to diabetes. | Estimates Time Below Range (TBR) with 95% confidence intervals for participants who received the CGM treatments. | 15 months |
1d. Impact of continuous and intermittent CGM use on the variability of blood glucose concentrations related to diabetes. | Estimates Time Above Range (TAR) with 95% confidence intervals for participants who received the CGM treatments. | 15 months |
2. Impact of continuous and intermittent CGM use on unplanned visits to outpatient clinics and/or hospital related to diabetes complications. | Number of hospitalizations related to diabetes complications per each group, represented by means and standard deviations. | 15 months |
3a. Impact of continuous and intermittent CGM use on quality of life of recipients of diabetes care and their caregivers (where applicable) | 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. | 15 months |
3b. Impact of continuous and intermittent CGM use on quality of life of recipients of diabetes care and their caregivers (where applicable) | Mixed methods : Qualitative methods FGD among recipients of care and their caregivers | 15 months |
4a. Acceptability and feasibility of continuous and intermittent CGM use from a healthcare provider, recipients of care and care givers perspective. | Mixed methods: Feasibility will be assessed based on Arm 1 and Arm 2 adherence to protocol in terms of CGM use. | 15 months |
4b.Acceptability and feasibility of continuous and intermittent CGM use from a healthcare provider, recipients of care and care givers perspective. | survey from baseline, midline, and endline among recipients of care and their caregivers. | 15 months |
4c. Acceptability and feasibility of continuous and intermittent CGM use from a healthcare provider, recipients of care and care givers perspective. | Mixed methods: Qualitative methods: SSI among health care providers involved in clinical care at the study sites. | 15 months |
5. Cost of continuous and intermittent CGM use from a user and provider perspective | 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. | 15 months |
Eligibility Criteria
Eligible Ages
Child, Adult, Older Adult
Minimum Age
4 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
- 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.
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
Foundation for Innovative New Diagnostics, SwitzerlandNo contact data.
3 Study Locations in 1 Countries
Gauteng
Steve Biko Academic Hospital, Pretoria, Gauteng, 0007, South Africa
Western Cape
Groote Schuur Hospital - Diabetes Centre, Cape Town, Western Cape, South Africa
Red Cross Hospital, Cape Town, Western Cape, South Africa