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De klinische studie NCT05918484 (UCMODY) voor Type 1 diabetes, MODY is afgerond. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag. | ||
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Kaartweergave
Usefulness of Continuous Glucose Monitoring in MODY Diagnosis (UCMODY) 500 Observationeel
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De klinische studie NCT05918484 (UCMODY) was een observationeel studie bij Type 1 diabetes, MODY en is nu afgerond. Er werd gestreefd naar inclusie van 500 deelnemers vanaf 1 juli 2023. De studie werd geleid door Castilla-La Mancha Health Service en was gepland te worden voltooid op 31 januari 2025. Laatste update op ClinicalTrials.gov: 10 februari 2025.
Beknopte samenvatting
Observational study about usefulness of intermittently scanned continuous glucose monitoring (isCGM) in the diagnosis of maturity-onset of the young (MODY) patients.
Uitgebreide beschrijving
Cross-sectional retrospective analysis of all patients with type 1 diabetes (T1D) in Castilla-La Mancha (south-central Spanish region) using intermittently scanned continuous glucose monitoring (isCGM). This study aimed to asses the usefulness of isCGM in the diagnosis of MODY patients that were previously wrongly diagnosed as T1D patients.
The following glycometrics were taking into account as MODY predictors: time...
Toon meerOfficiële titel
Usefulness of Intermittently Scanned Continuous Glucose Monitoring in the Diagnosis of Maturity-onset Diabetes of the Young (MODY) Patients
Aandoeningen
Type 1 diabetesMODYPublicaties
Wetenschappelijke artikelen en onderzoekspapers gepubliceerd over deze klinische studie:Andere studie-ID's
- UCMODY
- C-621
NCT-ID
Startdatum (Werkelijk)
2023-07-01
Laatste update geplaatst
2025-02-10
Verwachte einddatum
2025-01-31
Inschrijving (Geschat)
500
Studietype
Observationeel
Status
Afgerond
Armen / Interventies
| Deelnemersgroep/Studiearm | Interventie/Behandeling |
|---|---|
Type 1 diabetes patients All type 1 diabetes patients using intermittently scanned continuous glucose monitoring (isCGM) in Castilla-La Mancha (Spain). | Intermittenly scanned continuous glucose monitoring Use of Intermittenly scanned continuous glucose monitoring (FreeStyle Libre) and meeting the glycometric data criteria:
* Time in range 70-180 mg/L \>70%
* Glycemic management index \<7%
* Coefficient of variation \<36% MODY genetic diagnostic test Those patients fulfilling the glycometric data criteria and with clinical MODY suspicion:
* diagnosis before 35 years of age
* first-degree family history of diabetes.
* negative pancreatic autoimmunity (Ac GAD, IA-2A and Ac ZnT8)
* preserved pancreatic beta cell function defined as C-peptide \> 0.2 ng/mL in the presence of plasma glycemia \>140 mg/dL).
Those patients who meet the previous criteria will proceed to ...Toon meer |
Primaire uitkomst
Secundaire uitkomst
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
Positive predictive value | Positive predictive value of the combination of the glucometric variables TIR\>70%, GMI \<7% and CV \<36% in the diagnosis of MODY. Units % (min 0, max 100) | 14 days |
Negative predictive value | Negative predictive value of the combination of the glucometric variables TIR\>70%, GMI \<7% and CV \<36% in the diagnosis of MODY. Units % (min 0, max 100) | 14 days |
Sensitive | Sensitive of the combination of the glucometric variables TIR\>70%, GMI \<7% and CV \<36% in the diagnosis of MODY. Units % (min 0, max 100) | 14 days |
Specificity | Specificity of the combination of the glucometric variables TIR\>70%, GMI \<7% and CV \<36% in the diagnosis of MODY. Units % (min 0, max 100) | 14 days |
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
Percetage of wrongly diagnosed type 1 diabetes patients | To assess the percentage of MODY patients with misdiagnosis of DM1. Units % (min 0, max 100) | 14 days |
Time in range of interstitial glucose in MODY patients | To assess the percetage of time in range (70-180 mg/dL, 3.9-10 mmol/L) of interstitial glucose in patients finally diagnosed as MODY. Units % (min 0, max 100) | 14 days |
Time above range of interstitial glucose in MODY patients. | To assess the percentage of time above range (\>180 mg/dL, \>10 mmol/L) of patients finally diagnosed as MODY. Units % (min 0, max 100) | 14 days |
Time beloww range of interstitial glucose in MODY patients. | To assess the percentage of time bellow range (\<70 mg/dL, \<3.9 mmol/L) of patients finally diagnosed as MODY. Units % (min 0, max 100) | 14 days |
Coefficient of variation of interstitial glucose in MODY patients. | To assess the coefficient of variations of patients finally diagnosed as MODY. Units % (min 0, max 100) | 14 days |
isCGM daily scan frequency in MODY patients | To analyze the use of iCGM in patients finally diagnosed as MODY through daily frequency of scanning (number daily scans, min 0-max 100). | 14 days |
Percentage of iCGM in MODY patients | To analyze the percentage of iCGM use in patients finally diagnosed as MODY (% time in use, units %, mix 0- max 100). | 14 days |
Geschiktheidscriteria
Leeftijd van deelnemers
Volwassene, Oudere volwassene
Minimumleeftijd
18 Years
Geslachten die in aanmerking komen voor de studie
Allen
- Presence of T1D.
- Age equal or higher than 18 years old.
- In treatment with isCGM system.
- Active data in Libreview.
- isCGM use >70% of the possible time of use (isCGM data quality criteria).
- Time in range >70%, glucose management index <7% and coefficiente of variation <36% in the last 14 days glucometric recording.
- Not receiving treatment with isCGM.
- Diagnosis of T1D in the last three years.
- Gestation in progress or programmed pregnancy.
Castilla-La Mancha Health ServiceGeen contactgegevens beschikbaar
9 Studielocaties in 1 landen
Albacete
Albacete University Hospital, Albacete, Albacete, 02006, Spain
Ciudad Real
La Mancha-Centro Hospital, Alcázar de San Juan, Ciudad Real, 13600, Spain
Santa Barbara Hospital, Puertollano, Ciudad Real, 13500, Spain
Valdepeñas General Hospital, Valdepeñas, Ciudad Real, 13300, Spain
Cuenca
Virgen de la Luz University Hospital, Cuenca, Cuenca, 16002, Spain
Guadalajara
Guadalajara University Hospital, Guadalajara, Guadalajara, 19002, Spain
Malaga
Maria Jose Picon, Málaga, Malaga, 29010, Spain
Toledo
Virgen del Prado Hospital, Talavera de la Reina, Toledo, 45600, Spain
Toledo University Hospital, Toledo, Toledo, 45007, Spain