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Usefulness of Intermittently Scanned Continuous Glucose Monitoring in the Diagnosis of Maturity-onset Diabetes of the Young (MODY) Patients
Observational study about usefulness of intermittently scanned continuous glucose monitoring (isCGM) in the diagnosis of maturity-onset of the young (MODY) patients.
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 in range (70-180 mg/dL \>70%, Glucose Management Index \<7% y Coefficient of variation \<36%. Patient´s clinical records of subjects meeting these glycometric criteria were reviewed for clinical suspicious of MODY (diagnosis before 35 years of age, first-degree family history of diabetes, negative pancreatic autoimmunity, preserved pancreatic beta cell function. Those patients meeting isCGM and clinical suspicious criteria were offered a diagnostic test for MODY. The relationship between the qualitative outcome variable (MODY presence) and the quantitative variables will be performed using Student's t-test and ANOVA in situations of good fit with normality, and the Mann Whitney U and Kruskal Wallis when there is not a good fit with normality, and the Mann Whitney U and Kruskal Wallis when there is not.A P value \< 0.05 was considered statistically significant. The protocol was approved by the reference Castilla-La Mancha Public Health Institute Ethic Committee.
Age
18 - 100 years
Sex
ALL
Healthy Volunteers
No
Albacete University Hospital
Albacete, Albacete, Spain
La Mancha-Centro Hospital
Alcázar de San Juan, Ciudad Real, Spain
Santa Barbara Hospital
Puertollano, Ciudad Real, Spain
Valdepeñas General Hospital
Valdepeñas, Ciudad Real, Spain
Virgen de la Luz University Hospital
Cuenca, Cuenca, Spain
Guadalajara University Hospital
Guadalajara, Guadalajara, Spain
Maria Jose Picon
Málaga, Malaga, Spain
Virgen del Prado Hospital
Talavera de la Reina, Toledo, Spain
Toledo University Hospital
Toledo, Toledo, Spain
Start Date
July 1, 2023
Primary Completion Date
January 1, 2025
Completion Date
January 31, 2025
Last Updated
February 10, 2025
500
ACTUAL participants
Intermittenly scanned continuous glucose monitoring
DEVICE
MODY genetic diagnostic test
OTHER
Lead Sponsor
Castilla-La Mancha Health Service
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT04419480