Recruiting

Observational Study

Sponsor:

Institut de Recherches Cliniques de Montreal

Code:

NCT03720197

Conditions

Type 1 Diabetes Mellitus

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Online questionnaire - Phase 1

Online questionnaire - Phase 2

Online questionnaire - Phase 3

Food questionnaire

Pedometer

Study Details

Brief summary:

A registry of individuals with type 1 diabetes open to all patients with type 1 diabetes living in Canada will be established. The objective of this registry will be to measure the frequency and the severity of episodes of hypoglycemia. Participants will be invited to answer questionnaires about the frequency of their hypoglycemic episodes, their fear about hypoglycemia, their symptoms of hypoglycemia, the factors in cause (insulin therapy, nutrition, exercise, etc.), etc.

Participation to the registry is divided in 3 phases. The first phase is mandatory for all participants. Phases 2 and 3 are optional.

Conditions

Type 1 Diabetes Mellitus

Study ID

NCT03720197

Start date

Feb 20, 2019

Status verified date

Feb, 2025

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Diagnosis of type 1 diabetes
  • Living in Canada

Exclusion Criteria:

  • Type 2 diabetes
  • Gestational diabetes

Study Design

Enrollment

6000 participants

Anticipated

Interventions and Outcome Measures

Arms

Participants aged less than 14 years old

Participants aged 14 years old and older

Interventions

Online questionnaire - Phase 1

Draw an overall picture of the population with type 1 diabetes in Canada in terms of demographics, diabetes treatment, hypoglycemia frequency and diabetes complications.

Online questionnaire - Phase 2

Characterize the causes, experience and consequences of hypoglycemia.

Online questionnaire - Phase 3

Collect information on diabetes and hypoglycemia treatment, hyperglycemia management, sleep habits, depression, physical activity and the benefits of technologies to reduce the frequency of hypoglycemia.

Food questionnaire

24-hour food recall questionnaire

Pedometer

Participants will wear a podometer for 14 consecutives days

Waist circumference

Participants will be asked to measure their waist circumference

Blood and urine tests

Participants will be invited to send us their latests blood and urine test results.

List of medications

Participants will be invited to send us their list of medications

Continuous glucose monitor

Participants will be invited to send us the latest report of their continuous glucose monitor

Primary outcome measure

  • Number of non-severe hypoglycemic episodes [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Virginie Messier

514-987-5500virginie.messier@ircm.qc.ca

Locations

Alberta Diabetes Institute

Recruiting

Edmonton, Alberta, Canada, T6G 2T9

Principal Investigator:

Peter Senior

Institut de recherches cliniques de Montréal

Recruiting

Montreal, Quebec, Canada, H2W 1R7

Contacts

Virginie Messier

514-987-5696virginie.messier@ircm.qc.ca

Principal Investigator:

Remi Rabasa-Lhoret

Centre Hospitalier de l'Université de Montréal

Recruiting

Montreal, Quebec, Canada

Contacts

Remi Rabasa-Lhoret

514-987-5696remi.rabasa-lhoret@ircm.qc.ca

Principal Investigator:

Remi Rabasa-Lhoret

Centre Hospitalier Universitaire Sainte-Justine

Recruiting

Montreal, Quebec, Canada

Contacts

Catherine Pelletier

catherine.pelletier@recherche-ste-justine.qc.ca

Principal Investigator:

Melanie Henderson

McGill University Health Centre

Recruiting

Montreal, Quebec, Canada

Contacts

Laurent Legault

laurent.legault@muhc.mcgill.ca

Principal Investigator:

Laurent Legault

Centre hospitalier universitaire de Sherbrooke

Recruiting

Sherbrooke, Quebec, Canada

Contacts

Andre Carpentier

andre.carpentier@usherbrooke.ca

Principal Investigator:

Andre Carpentier

Centre Hospitalier Universitaire de Québec-Université Laval

Recruiting

Quebec, Canada

Contacts

Claudia Gagnon

claudia.gagnon@crchudequebec.ulaval.ca

Principal Investigator:

Claudia Gagnon

More Information

Sponsor

Institut de Recherches Cliniques de Montreal

Last update posted

Feb 25, 2025

Last verified

Feb, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Institut de Recherches Cliniques de Montreal on 2025-02-25.