Usefulness of Continuous Glucose Monitoring in MODY Diagnosis

Castilla-La Mancha Health Service500 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

500

Conditions

Type 1 Diabetes MODY

Interventions

Intermittenly scanned continuous glucose monitoringDEVICE

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%

MODY genetic diagnostic testOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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.

Locations (9)

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

Outcomes

Primary Outcomes

Positive predictive value

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)

Time frame: 14 days

Negative predictive value

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)

Time frame: 14 days

Sensitive

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)

Time frame: 14 days

Specificity

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)

Time frame: 14 days

Secondary Outcomes

Percetage of wrongly diagnosed type 1 diabetes patients

To assess the percentage of MODY patients with misdiagnosis of DM1. Units % (min 0, max 100)

Time frame: 14 days

Time in range of interstitial glucose in MODY patients

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 frame: 14 days

Time above range of interstitial glucose in MODY patients.

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)

Data from ClinicalTrials.gov

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