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De klinische studie NCT04358263 (CORRIDA) voor Diabetes mellitus type 1 is onbekend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag. | ||
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Karelsuniversiteit PraagIs Real-time CGM Superior to Flash Glucose Monitoring (CORRIDA) 60
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De klinische studie NCT04358263 (CORRIDA) is een interventioneel studie bij Diabetes mellitus type 1 met de status onbekend. Het doel is om 60 deelnemers te includeren vanaf 1 september 2018. De studie wordt geleid door Karelsuniversiteit Praag en de voltooiing is gepland op 30 november 2020. Laatste update op ClinicalTrials.gov: 28 april 2020.
Beknopte samenvatting
The aim of the investigator's study is to compare real-time continuous glucose monitoring and flash glucose monitoring in adult patients with Type 1 Diabetes during 4-day training program focused on physical activity and over 4 weeks of follow-up.
Officiële titel
Comparison of CGM in Randomised Study of Real-time and Intermittently-scanned Systems in T1D With Normal Awareness of Hypoglycemia (CORRIDA)
Aandoeningen
Diabetes mellitus type 1Publicaties
Wetenschappelijke artikelen en onderzoekspapers gepubliceerd over deze klinische studie:Andere studie-ID's
- CORRIDA
NCT-ID
Startdatum (Werkelijk)
2018-09-01
Laatste update geplaatst
2020-04-28
Verwachte einddatum
2020-11-30
Inschrijving (Geschat)
60
Studietype
Interventioneel
FASE
N.v.t.
Status
Onbekend
Trefwoorden
Continuous Glucose Monitoring
Flash Glucose Monitoring
Hypoglycemia
Time in Range
Physical Activity
Flash Glucose Monitoring
Hypoglycemia
Time in Range
Physical Activity
Primaire doel
Ondersteunende zorg
Toewijzing
Gerandomiseerd
Interventiemodel
Parallel
Blindering
Geen (Open-label)
Armen / Interventies
| Deelnemersgroep/Studiearm | Interventie/Behandeling |
|---|---|
ExperimenteelrtCGM Patients with use of the Guardian Connect Mobile system (real-time continuous glucose monitoring). | Continuous Glucose Monitoring Guardian Connect Mobile system (real-time continuous glucose monitoring) rtCGM and isCGM are used in Type 1 diabetic patients to improve glucose control and to minimize or avoid severe hypoglycaemia. |
ExperimenteelisCGM Patients with use of the FreeStyle Libre Flash system (intermittently-scanned continuous glucose monitoring). | Continuous Glucose Monitoring FreeStyle Libre Flash system (intermittently-scanned continuous glucose monitoring) rtCGM and isCGM are used in Type 1 diabetic patients to improve glucose control and to minimize or avoid severe hypoglycaemia. |
Primaire uitkomst
Secundaire uitkomst
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
Percentage of time in hypoglycemic ranges | \<3,9 mmol/L (70 mg/dl) and \<3,0 mmol/L (54 mg/dl) | Up to 2 months |
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
Percentage of time in target ranges | 3,9-10,0 mmol/L (70-180 mg/dl) | Up to 2 months |
Percentage of time in hyperglycemic ranges | (\>10,0 mmol/L (180 mg/dl) and \>13,9 mmol/L (250 mg/dl) | Up to 2 months |
Changes in glycemic variability | Expressed as the coefficient of variation | Up to 2 months |
Mean sensor glucose concentration | Measured by rtCGM or isCGM | Up to 2 months |
Changes in quality of life as assessed by validated questionnaire | Assessed by The World Health Organization Quality of Life (WHOQOL)-BREF (Field Trial Version).
This questionnaire contains in total 26 questions in four Domains (Physical health, Psychological health, Social relationships, Environment). Scores in total range between 4-20 (each Domain 0-5), higher scores denote higher quality of life. | Up to 2 months |
Incidence of severe hypoglycaemia | Requiring third-party assistance to treat | Up to 2 months |
Changes in glycated haemoglobin (HbA1c) | Differences between HbA1c values in the initial period and after follow-up and differences of HbA1c between groups. | Up to 2 months |
Geschiktheidscriteria
Leeftijd van deelnemers
Volwassene, Oudere volwassene
Minimumleeftijd
18 Years
Geslachten die in aanmerking komen voor de studie
Allen
- patients with T1D naive to rtCGM and isCGM
- Type 1 diabetes for >2 years
- ≥ 18 years old
- CSII or MDI
- GOLD score < 4, no history of severe hypoglycemia within last 6 month
- written informed consent prior to starting study related activity
- severe noncompliance
- severe diabetic retinopathy and/or macular edema
- lactation, pregnancy, intending to become pregnant during study
- condition likely to require MRI
- use of acetaminophen-containing medication
- unwillingness to use the study device for >70% of time
Karelsuniversiteit Praag84 actieve klinische studies om te verkennenVerantwoordelijke instantie
Jan Soupal, MD, Hoofdonderzoeker, Principal Investigator, Charles University, Czech Republic
Geen contactgegevens beschikbaar
1 Studielocaties in 1 landen
Czech Republic
3rd Department of Internal Medicine, 1st Faculty of Medicine Charles University, Prague, Czech Republic, Czechia