Usefulness of Continuous Glucose Monitoring in MODY Diagnosis (UCMODY)

Castilla-La Mancha Health Service

Status

Completed

Conditions

Type 1 Diabetes

MODY

Treatments

Device: Intermittenly scanned continuous glucose monitoring

Other: MODY genetic diagnostic test

Study type

Observational

Funder types

Other

Identifiers

NCT05918484

C-621

Details and patient eligibility

About

Observational study about usefulness of intermittently scanned continuous glucose monitoring (isCGM) in the diagnosis of maturity-onset of the young (MODY) patients.

Full description

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.

Enrollment

500 patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria