NCT06573905

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
17,271

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 27, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

January 1, 2025

Status Verified

December 1, 2024

Enrollment Period

6 months

First QC Date

August 23, 2024

Last Update Submit

December 30, 2024

Conditions

Keywords

medico-administrative algorithmscohort studyobservational studydiabetes

Outcome Measures

Primary Outcomes (3)

  • Diagnostic Accuracy Measures (Percentages)

    The primary outcome measure is the accuracy of the medico-administrative algorithms in correctly classifying participants into one of the following diabetes phenotypes: Type 1, Type 2, LADA, or Other Phenotypes, compared to clinical or self-reported diagnoses. 1.1. Diagnostic Accuracy Measures (Percentages) * Sensitivity (Se) * Specificity (Sp) * Positive Predictive Value (PPV) * Negative Predictive Value (NPV) All reported as proportions or percentages. These indicators will not be aggregated into a single value, but will be presented separately to respect their distinct units of measurement.

    Retrospective data from 1997 to 2024

  • Classification Counts (Number of Cases)

    The primary outcome measure is the accuracy of the medico-administrative algorithms in correctly classifying participants into one of the following diabetes phenotypes: Type 1, Type 2, LADA, or Other Phenotypes, compared to clinical or self-reported diagnoses. 1.2. Classification Counts (Number of Cases) * True Positives (TP) * True Negatives (TN) * False Positives (FP) * False Negatives (FN) All reported as counts of participants. These indicators will not be aggregated into a single value, but will be presented separately to respect their distinct units of measurement.

    Retrospective data from 1997 to 2024

  • Likelihood Ratios (Unitless)

    The primary outcome measure is the accuracy of the medico-administrative algorithms in correctly classifying participants into one of the following diabetes phenotypes: Type 1, Type 2, LADA, or Other Phenotypes, compared to clinical or self-reported diagnoses. 1.3. Likelihood Ratios (Unitless) * Positive Likelihood Ratio (LR+) * Negative Likelihood Ratio (LR-) Reported as unitless ratios. These indicators will not be aggregated into a single value, but will be presented separately to respect their distinct units of measurement.

    Retrospective data from 1997 to 2024

Secondary Outcomes (2)

  • Prevalence of Each Diabetes Phenotype (Proportion/Percentage)

    Retrospective data from 1997 to 2024

  • Incidence of Each Diabetes Phenotype

    Retrospective data from 1997 to 2024

Study Arms (5)

type 1 diabetes

This group comprises participants diagnosed with Type 1 diabetes according to self-reported data. The primary goal of comparing this group with medico-administrative records is to validate the algorithm's ability to accurately classify individuals with Type 1 diabetes, ensuring that they are correctly identified as such without being misclassified into other categories.

Other: no intervention

type 2 diabetes

This group includes participants diagnosed with Type 2 diabetes based on clinical data. The validation process focuses on assessing the algorithm's accuracy in identifying individuals with Type 2 diabetes, ensuring correct classification and minimizing the risk of misclassification as other diabetes phenotypes or non-diabetic.

Other: no intervention

Latent autoimmune diabete in adults

This group consists of participants diagnosed with Latent Autoimmune Diabetes in Adults (LADA) according to self-reported data. The validation process for this group focuses on assessing the algorithm's ability to accurately identify individuals with LADA, which is often challenging due to its characteristics that overlap with both Type 1 and Type 2 diabetes. Accurate classification of LADA is crucial for improving treatment strategies and understanding its epidemiology.

Other: no intervention

Non-diabetic

This group includes participants who, according to self-reported data from individuals, do not have any phenotypes of diabetes. The comparison of this group's data with medico-administrative records is crucial for identifying false positives and ensuring that the algorithms accurately exclude non-diabetic individuals from being misclassified as having diabetes.

other phenotypes

This group contains participants diagnosed with diabetes-related phenotypes other than Type 1, Type 2, or LADA, as well as those with rarer forms of the disease (based on clinical data). The validation aims to determine the algorithm's effectiveness in correctly identifying and classifying these less common phenotypes, which is critical for ensuring comprehensive and accurate diabetes classification.

Other: no intervention

Interventions

no intervention. this is observational study.

Latent autoimmune diabete in adultsother phenotypestype 1 diabetestype 2 diabetes

Eligibility Criteria

Age1 Year - 40 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

The study population consists of individuals diagnosed with Type 1, Type 2, or LADA diabetes, as well as other diabetes-related phenotypes, within the province of Quebec. The population includes children, adolescents, and young adults up to 40 years of age at the time of diagnosis. The cohort is drawn from a comprehensive dataset of medical, self-reported, and medico-administrative records spanning from 1997 to 2024. This diverse population allows for a robust validation of the diabetes classification algorithms across different age groups and phenotypes, providing valuable insights into the epidemiology of diabetes in Quebec.

You may qualify if:

  • 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.

You may not qualify if:

  • Non-residents of Quebec during the study period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Philippe Corsenac

Montreal, Quebec, J8X 3X7, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • philippe C corsenac, Ph.D

    UQO

    PRINCIPAL INVESTIGATOR

Central Study Contacts

philippe C corsenac, Ph.D

CONTACT

jeremie Riou, Ph.D

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr in epidemiology and immunology

Study Record Dates

First Submitted

August 23, 2024

First Posted

August 27, 2024

Study Start

January 1, 2025

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

January 1, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

no planned

Locations