Usefulness of Continuous Glucose Monitoring in MODY Diagnosis

NCT05918484 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2025-02-10

No results posted yet for this study

Summary

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

Conditions

Interventions

DEVICE

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%

OTHER

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 the MODY genetic diagnostic test.

Sponsors & Collaborators

  • Castilla-La Mancha Health Service

    lead OTHER

Principal Investigators

  • Jesus Moreno-Fernandez, PhD · SESCAM

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-01
Primary Completion
2025-01-01
Completion
2025-01-31
FDA Device
Yes

Countries

  • Spain

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05918484 on ClinicalTrials.gov