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Lo studio clinico NCT05944718 (ACCEDE) per Diabete di tipo 1 è completato. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui. | ||
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Use of Continuous Glucose Monitoring Devices Among People Living With Type 1 Diabetes in South Africa (ACCEDE) 246
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La sperimentazione clinica NCT05944718 (ACCEDE) è stata uno studio interventistico per Diabete di tipo 1, attualmente completato. Avviato il 11 settembre 2023, prevedeva di arruolare 246 partecipanti. Sotto la guida di Foundation for Innovative New Diagnostics, Switzerland, si è concluso il 31 luglio 2025. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 12 agosto 2025.
Sommario breve
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...Mostra di più
Descrizione dettagliata
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...Mostra di più
Titolo ufficiale
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
Patologie
Diabete di tipo 1Pubblicazioni
Articoli scientifici e documenti di ricerca pubblicati su questo studio clinico:Altri ID dello studio
- ACCEDE
- NC008
Numero NCT
Data di inizio (effettiva)
2023-09-11
Ultimo aggiornamento pubblicato
2025-08-12
Data di completamento (stimata)
2025-07-31
Arruolamento (previsto)
246
Tipo di studio
Interventistico
FASE
N.D.
Stato
Completato
Parole chiave
continuous glucose monitoring
Scopo principale
Diagnostico
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Nessuno (studio in aperto)
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
SperimentaleArm 1 Arm 1 is those participants randomized to use of CGM in a continuous fashion; CGM use for the duration of 9 months. | Monitoraggio continuo del glucosio 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...Mostra di più |
SperimentaleArm 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. | Monitoraggio continuo del glucosio 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...Mostra di più |
Nessun interventoArm 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.D. |
Esito primario
Esito secondario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
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 |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
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 |
Criteri di eleggibilità
Età idonea
Bambino, Adulto, Adulto anziano
Età minima
4 Years
Sessi idonei
Tutti
Accetta volontari sani
Sì
- 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, SwitzerlandNessun dato di contatto
3 Centri dello studio in 1 paesi
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