NCT05918484

Usefulness of Continuous Glucose Monitoring in MODY Diagnosis

Usefulness of Intermittently Scanned Continuous Glucose Monitoring in the Diagnosis of Maturity-onset Diabetes of the Young (MODY) Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 500 (actual)
• Sponsor: Castilla-La Mancha Health Service · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Type 1 Diabetes
• MODY

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-07-01
• Primary completion: 2025-01-01
• Completion: 2025-01-31
• First posted: 2023-06-26
• Last updated: 2025-02-10

Locations

9 sites across 1 country: Spain

Regulatory

• FDA-regulated device study