Usefulness of Continuous Glucose Monitoring in MODY Diagnosis (UCMODY)

January 10, 2024 updated by: Castilla-La Mancha Health Service

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

4000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Albacete, Spain, 02006
        • Recruiting
        • Albacete University Hospital
        • Contact:
        • Sub-Investigator:
          • Jose Joaquin Alfaro
        • Sub-Investigator:
          • Pedro Pines
      • Cuenca, Spain, 16002
        • Recruiting
        • Virgen de la Luz University Hospital
        • Contact:
        • Contact:
          • Phone Number: 0034969179900
        • Sub-Investigator:
          • Dulce Calderon
        • Sub-Investigator:
          • Javier Gonzalez
      • Guadalajara, Spain, 19002
        • Recruiting
        • Guadalajara University Hospital
        • Contact:
      • Toledo, Spain, 45007
        • Recruiting
        • Toledo University Hospital
        • Contact:
        • Sub-Investigator:
          • Esther Maqueda
        • Sub-Investigator:
          • Amparo Marco
        • Sub-Investigator:
          • Julia Sastre
    • Ciudad Real
      • Alcázar De San Juan, Ciudad Real, Spain, 13600
        • Recruiting
        • La Mancha-Centro Hospital
        • Contact:
      • Puertollano, Ciudad Real, Spain, 13500
        • Recruiting
        • Santa Barbara Hospital
        • Contact:
      • Valdepeñas, Ciudad Real, Spain, 13300
        • Recruiting
        • Valdepeñas General Hospital
        • Contact:
    • Malaga
      • Málaga, Malaga, Spain, 29010
        • Recruiting
        • Maria Jose Picon
        • Contact:
        • Principal Investigator:
          • Maria Jose Picon, PhD
    • Toledo
      • Talavera De La Reina, Toledo, Spain, 45600
        • Recruiting
        • Virgen del Prado Hospital
        • Contact:
        • Contact:
          • Phone Number: 0034925803600

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All T1D patients using isCGM in Castilla-La Mancha Public Health Service

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Type 1 diabetes patients
All type 1 diabetes patients using intermittently scanned continuous glucose monitoring (isCGM) in Castilla-La Mancha (Spain).
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive predictive value
Time Frame: 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)
14 days
Negative predictive value
Time Frame: 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)
14 days
Sensitive
Time Frame: 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)
14 days
Specificity
Time Frame: 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)
14 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Castilla-La Mancha Health Service

Investigators

  • Principal Investigator: Jesus Moreno-Fernandez, PhD, SESCAM

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2023

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

March 1, 2024

Study Registration Dates

First Submitted

June 7, 2023

First Submitted That Met QC Criteria

June 15, 2023

First Posted (Actual)

June 26, 2023

Study Record Updates

Last Update Posted (Actual)

January 11, 2024

Last Update Submitted That Met QC Criteria

January 10, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-621

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Under other researchers request.

IPD Sharing Time Frame

1 monty after requested.

IPD Sharing Access Criteria

Under other researchers request and after the approval of all researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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