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Not yet recruiting NCT06573905

Mapping Diabetes in Quebec: Validating Medico-administrative Algorithms for Type 1 Diabetes, Type 2 Diabetes and LADA

Observational Diabetes Mellitus, Type 1 Diabete Type 2 Diabetes;Adult Onset Diabetes, Autoimmune

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: no intervention.
Who it may be relevant to
Registry conditions: Diabetes Mellitus, Type 1, Diabete Type 2, Diabetes;Adult Onset, Diabetes, Autoimmune. Basic parameters: 1 year — 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

The goal of this observational study is to validate medico-administrative algorithms that classify diabetes phenotypes (Type 1, Type 2, and Latent Autoimmune Diabetes in Adults - LADA) in a population-based cohort in Quebec, including children, adolescents, and young adults up to 40 years old with diagnosed diabetes. The main questions it aims to answer are: Can these algorithms accurately distinguish between Type 1, Type 2, and LADA across different age groups? What is the prevalence and incidence of each diabetes phenotype in Quebec? Participants will have their medical and administrative data analyzed, including data on medication usage and healthcare visits, to validate the accuracy of the algorithms. The study will involve comparing these algorithm-based classifications with clinical diagnoses or self-reported data to ensure reliability.

Detailed description

The goal of this observational study is to validate the effectiveness of medico-administrative algorithms developed to classify diabetes phenotypes, specifically Type 1, Type 2, and Latent Autoimmune Diabetes in Adults (LADA), in a population-based cohort in Quebec. The study focuses on children, adolescents, and young adults up to 40 years old who have been diagnosed with diabetes.

The main questions it aims to answer are:

Can these algorithms accurately differentiate between Type 1, Type 2, and LADA across various age groups? What are the prevalence and incidence rates of these diabetes phenotypes in the Quebec population? Participants, who are already diagnosed with one of the three diabetes types and receiving standard medical care, will have their data collected from existing medical and administrative records. This data includes information on medication usage, healthcare visits, and self-reported health outcomes.

The study will involve a retrospective analysis where the classifications made by the algorithms will be compared with clinical diagnoses and self-reported data to determine the accuracy and reliability of the algorithms. This validation process is crucial for improving diabetes management and public health strategies by ensuring that these algorithms can be reliably used in broader epidemiological studies.

Interventions

  • Other no intervention
    no intervention. this is observational study.

Primary outcome measures

  • Diagnostic Accuracy Measures (Percentages) [Time frame: Retrospective data from 1997 to 2024]
  • Classification Counts (Number of Cases) [Time frame: Retrospective data from 1997 to 2024]
  • Likelihood Ratios (Unitless) [Time frame: Retrospective data from 1997 to 2024]
Secondary outcome measures (2)
  • Prevalence of Each Diabetes Phenotype (Proportion/Percentage) [Time frame: Retrospective data from 1997 to 2024]
  • Incidence of Each Diabetes Phenotype [Time frame: Retrospective data from 1997 to 2024]

Eligibility criteria

Inclusion criteria

  • Individuals diagnosed with Type 1, Type 2, or Latent Autoimmune Diabetes in Adults (LADA) based on clinical or self-reported data.
  • Participants diagnosed between 1997 and 2024.
  • Residents of Quebec with available medico-administrative records from 1997 to 2024.

Exclusion criteria

  • Non-residents of Quebec during the study period.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Canada · 1 center
  • Philippe Corsenac — Montreal

Identifiers

NCT: NCT06573905 · F1-14464

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗