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Type 1 DiabetesACCEDENCT05944718

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

A study testing Continuous glucose monitor in people with Type 1 Diabetes, run by Foundation for Innovative New Diagnostics, Switzerland at 3 sites in South Africa.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 4 years and olderHealthy volunteers can take part
Conditions the study is for
Type 1 Diabetes
What is being tested?
Continuous glucose monitor
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
246 participants
Where
3 sitesSouth Africa
Study dates
11 Sep 2023to 31 Jul 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

South Africa3 sites

  • Groote Schuur Hospital - Diabetes Centre

    Cape Town, Western Cape

  • Red Cross Hospital

    Cape Town, Western Cape

  • Steve Biko Academic Hospital

    Pretoria, Gauteng, 0007

Other trials in South Africa

About this study

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

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.

Read the 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 already used in these clinics. It is important to note that the type of HbA1c test (i.e.: laboratory-based vs point-of-care) per participant must remain constant during the study, this is because of variability of performance between various HbA1c testing platforms.

3.1 General Design This is a three-arm pragmatic randomized control study. The expected duration of study participants involvement in the study is 15 months, this consists of 9 months of intervention with a follow up visit 6 months post the last interventional study visit. There will be 6 total study visits for all participants.

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

For all participants the first study visit will consist of:

  1. Enrolment including ICF,
  2. Baseline surveys including demographics, the Glucose Monitoring Satisfaction Survey (GMSS-T1D), HRQOL surveys, and diabetes distress score survey.
  3. Randomized assignment to study arm,
  4. Blood draw for HbA1c testing (if not already done in the previous 1 month).

Those participants randomized to Arm 1 and Arm 2 will receive an education session on the CGM, be provided with the CGM, and be guided how to self-apply the CGM during enrolment visit.

During all Study Follow Up visits participants will have blood drawn for HbA1c testing, complete a brief survey to capture any hospitalizations and/or hypoglycaemic events related to diabetes complications that occurred between study visits.

Additionally, during Study Follow up visit C participants will complete the Glucose Monitoring Satisfaction Survey (GMSS-T1D), diabetes distress score survey, and an acceptability survey. During Study Follow up visit D, participants will complete the HRQOL surveys and diabetes distress score survey. During Study Follow up visit E participants will complete the Glucose Monitoring Satisfaction Survey (GMSS-T1D), diabetes distress score survey, and HRQOL surveys.

Detailed explanation of the study visits per arm are outlined below by arm in section 3.1.1, 3.1.2, 3.1.3

Qualitative methods used across all arms will consist of focus group discussions (FGDs) among the participants and caregivers of participants. Approximately 15 participants above the age of 18 years old will be selected from each arm (n=45, 3 FGD in total) and approximately 15 participants age range of 11 to 17 years old will be selected from each arm (n=45, 3 FGD in total) to participate in arm specific FGD to take place 30 to 35 weeks after study enrolment started. These FGDs will focus on understanding participant perceptions towards their current glucose monitoring devices and quality of life. To capture the perspectives of care givers of children and adolescents living with T1 diabetes 15 caregivers will be selected from each arm (n=45, 3 FGD in total) to participate in arm specific FGDs to take place 30 to 35 weeks after study enrolment started. These FGDs will focus on understanding care giver perspectives towards their minor's glucose monitoring devices and quality of life from the perspective of the care giver as well as their perceptions towards the quality of life for their minor.

Qualitative methods will also be used to gather perceptions from the healthcare providers regarding their perceptions surrounding the feasibility and acceptability of use of CGMs in their settings. This will consist of a semi-structured interviews (SSI) of selected HCW (n=10 total) to be conducted after week 36 after study enrolment started.

3.1.1 Arm 1 Continuous use of CGM For those in Arm 1 there will be 6 study visits for all participants. There will be an additional visit for a FGD among a subset of participants.

  1. Enrolment visit: For those randomized to Arm 1 they will receive an education session on the CGM, be provided with the CGM, blood will be drawn for HbA1c testing (where this is standard of care) and be guided how to self-apply the CGM during enrolment visit.
  2. Study Follow up A: The second study visit will take place 1 week after the enrolment visit. During this second visit the participant will see the clinician and review the CGM data from the first week. Participants in Arm 1 will be provided with 6 additional CGMs to continually use the CGM devices until their third study visit (Study Follow up B) to take place 12 weeks after enrolment.
  3. Study Follow up B: At the third study visit participants will see the clinician and review the CGM data from the period of time in between second study visit and current, blood will be drawn for HbA1c testing, and the participant will be provided with 6 additional CGMS such that they continually use the CGM devices until their fourth study visit (Study Follow up C) to take place at 24 weeks after enrolment.
  4. Study Follow up C: At the fourth study visit participants will see the clinician and review the CGM data from the period of time in between third study visit and current, blood will be drawn for HbA1c testing, and the participant will be provided with 6 additional CGMS such that the continually use the CGM devices until their fifth study visit (Study Follow up D) to take place at 36 weeks after enrolment.
  5. Study Follow up D: At the fifth study visit participants will see the clinician and review the CGM data from the period in between fourth study visit and current, blood will be drawn for HbA1c testing and the participant will be provided with 1 additional CGM to use for the week following Study follow up C.
  6. Study Follow up E: At the sixth and final study visit which takes place at 58 weeks after enrolment study participants will see the clinician and blood will be drawn for HbA1c.

3.1.2 Arm 2 Intermittent use of CGM For those in Arm 2 there will be 6 study visits for all participants. There will be an additional visit for a FGD among a subset of participants.

  1. Enrolment visit: For those randomized to Arm 2 they will receive an education session on the CGM, be provided with the CGM, blood will be drawn for HbA1c testing, and be guided how to self-apply the CGM during enrolment visit.
  2. Study Follow up A: The second study visit will take place 1 week after the enrolment visit. During this second visit the participant will see the clinician and review the CGM data from the first week. During Study follow up A participants in Arm 2 will be provided 1 CGM to use starting 1 week before their third study visit (Study Follow up B) to take place at 12 weeks after enrolment.
  3. Study Follow up B: At the third study visit participants will see the clinician and review the CGM data from the preceding week before Study follow up A, blood will be drawn for HbA1c testing, and the participant will be provided with 1 additional CGM such that the participant uses the CGM for the week directly following Study follow up A and 1 week before their fourth study visit (Study Follow up C) to take place at 24 weeks after enrolment.
  4. Study Follow up C: At the fourth study visit participants will see the clinician and review the CGM data from the preceding week before Study follow up B, blood will be drawn for HbA1c testing, and the participant will be provided with 1 additional CGM such that the participant uses the CGM for the week directly following Study follow up A, and 1 week before their fifth study visit (Study Follow up D) to take place 36 weeks after enrolment.
  5. Study Follow up D: At the fifth study visit participants will see the clinician and review the CGM data from the week preceding Study Follow up D, blood will be drawn for HbA1c testing and the participant will be provided with 1 additional CGM to use for the week following Study follow up D.
  6. Study Follow up E: At the sixth and final study visit which takes place at 58 weeks after enrolment study participants will see the clinicals and blood will be drawn for HbA1c.

3.1.3 Arm 3 Standard of Care For those in Arm 3 there will be 6 study visits for all participants. There will be an additional visit for a FGD among a subset of participants. Participants will follow the standard of care at each clinic.

  1. Enrolment visit: Those participants randomized to Arm 3 will undergo blood drawn for HbA1c testing.
  2. Study Follow up A: The second visit will take place 1 week after the enrolment visit. Participants will see their clinician at the enrolment visit as per SoC
  3. Study Follow up B: The third study visit will take place at 12 weeks after enrolment, participants will see the clinician as per SoC. Blood will be drawn for HbA1c testing.
  4. Study Follow up C: The fourth study visit will take place at 24 weeks after enrolment. participants will see the clinician as per SoC. Blood will be drawn for HbA1c testing.
  5. Study Follow up D: The fifth study visit will take place at the end of 35 weeks after enrolment. Participants will see the clinician as per SoC. Blood will be drawn for HbA1c.
  6. Study Follow up E: The sixth and final study visit will take place at 58 weeks after enrolment. participants will see the clinician as per SoC. Blood will be drawn for HbA1c. After completion of study participation, those in Arm 3 will be offered 1 CGM to use such that they can experience CGM use. Those participants who accept the CGM will be provided with an education session on CGM use before application.

3.2 Scientific Rationale for Study Design As this study intendeds to generate evidence to inform policy and decision makers on the potential benefits of use of CGM in South Africa a pragmatic, rather than an explanatory, randomized control study design was selected [9]. A PrCT design was selected as the study aims to understand the impact of CGM use in as close to real world settings as possible. A classically designed randomized control trial with overly strict study criteria and processes may lead results that are not directly translatable to real world experience, while a classical RCT may have strong internal validity often RCTs are criticized for a lack of external validity, therefore a PrCT design was selected to balance internal and external validity [12]. A PrCT design may "provide more realistic effect size estimates and enhance translation of research findings into clinical practice".

Conditions
Type 1 Diabetes
Being tested
Continuous glucose monitor
Keywords
continuous glucose monitoring
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Continuous glucose monitorDevice

    Also called Freestyle Libre Abbott

    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.

Study groups in NCT05944718
Study groupRoleWhat they receive
Arm 1ExperimentalArm 1 is those participants randomized to use of CGM in a continuous fashion; CGM use for the duration of 9 months.
Receives: Device: Continuous glucose monitor
Arm 2ExperimentalArm 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.
Receives: Device: Continuous glucose monitor
Arm 3No interventionArm 3 is those participants randomized to standard of care; regular use of self-monitoring of blood glucose (SMBG) for the duration of 9 months.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 15 months

Secondary outcomes (11)

  1. 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.

    Measured: 15 months

  2. 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.

    Measured: 15 months

  3. 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.

    Measured: 15 months

  4. 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.

    Measured: 15 months

  5. 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.

    Measured: 15 months

  6. 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.

    Measured: 15 months

  7. 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

    Measured: 15 months

  8. 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.

    Measured: 15 months

  9. 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.

    Measured: 15 months

  10. 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.

    Measured: 15 months

  11. 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.

    Measured: 15 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2023
  2. Study start11 Sep 2023
  3. Primary completion31 Jul 2025
  4. Study completion31 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
246 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05944718
Sponsor's protocol ID
NC008
Acronym
ACCEDE
Status last verified
Aug 2025
First submitted
19 Jun 2023
Last updated
12 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32312858

  • 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.

    PubMed 28118454

  • 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.

    PubMed 28118453

  • 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.

    PubMed 30681379

  • 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.

    PubMed 36494845

  • 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.

    PubMed 27154973

  • 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.

  • 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.

  • 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.

  • Treweek S, Zwarenstein M. Making trials matter: pragmatic and explanatory trials and the problem of applicability. Trials. 2009 Jun 3;10:37. doi: 10.1186/1745-6215-10-37.

    PubMed 19493350

  • Hohenschurz-Schmidt DJ, Cherkin D, Rice ASC, Dworkin RH, Turk DC, McDermott MP, Bair MJ, DeBar LL, Edwards RR, Farrar JT, Kerns RD, Markman JD, Rowbotham MC, Sherman KJ, Wasan AD, Cowan P, Desjardins P, Ferguson M, Freeman R, Gewandter JS, Gilron I, Grol-Prokopczyk H, Hertz SH, Iyengar S, Kamp C, Karp BI, Kleykamp BA, Loeser JD, Mackey S, Malamut R, McNicol E, Patel KV, Sandbrink F, Schmader K, Simon L, Steiner DJ, Veasley C, Vollert J. Research objectives and general considerations for pragmatic clinical trials of pain treatments: IMMPACT statement. Pain. 2023 Jul 1;164(7):1457-1472. doi: 10.1097/j.pain.0000000000002888. Epub 2023 Mar 22.

    PubMed 36943273

  • 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.

    PubMed 25956159

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

  • 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.

    PubMed 19897823

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

Questions about this trial

What is this clinical trial studying?

A study testing Continuous glucose monitor in people with Type 1 Diabetes, run by Foundation for Innovative New Diagnostics, Switzerland at 3 sites in South Africa.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05944718, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025; AzTrials last refreshed its copy on 8 Nov 2026.

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