Usefulness of Continuous Glucose Monitoring in MODY Diagnosis

Completed

• Conditions: Type 1 Diabetes; MODY
• Interventions: Device: Intermittenly scanned continuous glucose monitoring; Other: MODY genetic diagnostic test

• Registration Number: NCT05918484
• Lead Sponsor: Castilla-La Mancha Health Service

Brief 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.

Study Timeline

• Study First Submitted: 2023-06-07
• Study First Submitted QC: 2023-06-15
• Study First Posted: 2023-06-26
• Study Start: 2023-07-01
• Primary Completion: 2025-01-01
• Study Completion: 2025-01-31
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-06
• Last Update Posted: 2025-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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

• Not receiving treatment with isCGM.
• Diagnosis of T1D in the last three years.
• Gestation in progress or programmed pregnancy.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Type 1 diabetes patients	Intermittenly scanned continuous glucose monitoring	All type 1 diabetes patients using intermittently scanned continuous glucose monitoring (isCGM) in Castilla-La Mancha (Spain).
Type 1 diabetes patients	MODY genetic diagnostic test	All type 1 diabetes patients using intermittently scanned continuous glucose monitoring (isCGM) in Castilla-La Mancha (Spain).

Primary Outcome Measures

Name	Time	Method
Sensitive	14 days	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)
Specificity	14 days	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)
Negative predictive value	14 days	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)
Positive predictive value	14 days	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)

Secondary Outcome Measures

Name	Time	Method
Percentage of iCGM in MODY patients	14 days	To analyze the percentage of iCGM use in patients finally diagnosed as MODY (% time in use, units %, mix 0- max 100).
Percetage of wrongly diagnosed type 1 diabetes patients	14 days	To assess the percentage of MODY patients with misdiagnosis of DM1. Units % (min 0, max 100)
Time in range of interstitial glucose in MODY patients	14 days	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)
Time above range of interstitial glucose in MODY patients.	14 days	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)
Time beloww range of interstitial glucose in MODY patients.	14 days	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)
Coefficient of variation of interstitial glucose in MODY patients.	14 days	To assess the coefficient of variations of patients finally diagnosed as MODY. Units % (min 0, max 100)
isCGM daily scan frequency in MODY patients	14 days	To analyze the use of iCGM in patients finally diagnosed as MODY through daily frequency of scanning (number daily scans, min 0-max 100).

Trial Locations

Locations (9)

Santa Barbara Hospital; 🇪🇸 Puertollano, Ciudad Real, Spain

Albacete University Hospital; 🇪🇸 Albacete, Spain

La Mancha-Centro Hospital; 🇪🇸 Alcázar De San Juan, Ciudad Real, Spain

Maria Jose Picon; 🇪🇸 Málaga, Malaga, Spain

Virgen de la Luz University Hospital; 🇪🇸 Cuenca, Spain

Guadalajara University Hospital; 🇪🇸 Guadalajara, Spain

Valdepeñas General Hospital; 🇪🇸 Valdepeñas, Ciudad Real, Spain

Virgen del Prado Hospital; 🇪🇸 Talavera De La Reina, Toledo, Spain

Toledo University Hospital; 🇪🇸 Toledo, Spain