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Clinical trial Recruiting at 1 site Observational Ages 1 Day to 25

Identifying Monogenic Diabetes Misdiagnosed as Type 1

Official title: Accurate Diagnosis of Diabetes for Appropriate Management

Run by McGill University Health Centre/Research Institute of the McGill University Health Centre · NCT03988764 · Data updated 2026-11-12

This study is trying to find out how often young people are wrongly diagnosed with type 1 diabetes when they actually have a rare form called monogenic diabetes, by testing their blood and looking for specific genetic changes.

Quick facts

Study typeObservational
Ages1 Day to 25 Years
SexAll
Enrollment5000 (estimated)
SponsorMcGill University Health Centre/Research Institute of the McGill University Health Centre
Academic / other
Locations1 site (Montreal, Quebec)
StatusRecruiting
StartedSeptember 24, 2019
Main results expectedDecember 31, 2025
Study endsDecember 31, 2025
Registry record updatedDecember 10, 2024
Trial IDNCT03988764 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are individuals diagnosed with diabetes under the age of 25 who have either type 1 diabetes or an undetermined type.

Probably not a fit

Patients with a positive result on existing T1D autoantibody testing will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to determine how often monogenic diabetes is misdiagnosed as type 1 diabetes (T1D) in individuals under 25 years old. It will recruit 5,000 participants from 17 clinics across Canada, testing them for specific autoantibodies and performing exome sequencing on those negative for all four antibodies. The study will analyze various clinical variables to develop a predictive algorithm for identifying monogenic diabetes cases. Additionally, it seeks to discover novel genetic mutations associated with monogenic diabetes that may have been overlooked.

Why it matters

Potential benefit: If successful, this study could lead to more accurate diagnoses and tailored treatments for patients with monogenic diabetes.

How similar studies have gone: Other studies have shown success in identifying genetic causes of diabetes, but this specific approach to misdiagnosis is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Diagnosis of diabetes under the age of 25 as either type 1 or undetermined type.

Exclusion Criteria:

* Existing T1D autoantibody testing with a positive result

Where it's running

  • The Montreal Children's Hospital
    Montreal, Quebec, Canada     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov ↗ Find more trials like this →
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.