Registry of Patients Living With Type 1 Diabetes

December 21, 2023 updated by: Rémi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal

Registry of Individuals With Type 1 Diabetes Living in Canada: The BETTER Registry

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The objective of phase 1 is to draw an overall picture of the population with type 1 diabetes in Canada in terms of demographics, diabetes treatment, hypoglycemia frequency and diabetes complications. It takes about 10 minutes to answer the questionnaire. If the participant uses a continuous glucose monitor and agrees, the participant is invited to send the latest report of the continuous glucose monitor.

The objective of phase 2 is to characterize the causes, experience and consequences of hypoglycemia. Phase 2 also involves, if the participant accepts and live in the province of Quebec or Alberta, to provide the research team with their latest blood and urine tests as well as their list of medications.

The objective of phase 3 is to 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. Phase 3 also involves, if the participant agrees, answering a food questionnaire, wearing a step counter, measuring waist circumference

Study Type

Observational

Enrollment (Estimated)

6000

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 Locations

  • Canada
      • Quebec, Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2T9
        • Recruiting
        • Alberta Diabetes Institute
        • Contact:
          • Jyoti Singh
        • Principal Investigator:
          • Peter Senior
    • Quebec
      • Montreal, Quebec, Canada, H2W 1R7
        • Recruiting
        • Institut de Recherches Cliniques de Montreal
        • Principal Investigator:
          • Remi Rabasa-Lhoret
        • Contact:
      • Montreal, Quebec, Canada
        • Recruiting
        • McGill University Health Centre
        • Contact:
        • Principal Investigator:
          • Laurent Legault
        • Sub-Investigator:
          • Kaberi Dasgupta
        • Sub-Investigator:
          • Meranda Nakhla
      • Montreal, Quebec, Canada
        • Recruiting
        • Centre Hospitalier de l'Université de Montréal
        • Principal Investigator:
          • Remi Rabasa-Lhoret
        • Contact:
      • Montreal, Quebec, Canada
      • Sherbrooke, Quebec, Canada
        • Recruiting
        • Centre Hospitalier Universitaire de Sherbrooke
        • Contact:
        • Principal Investigator:
          • Andre Carpentier

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Individuals with type 1 diabetes living in Canada.

Description

Inclusion Criteria:

  • Diagnosis of type 1 diabetes
  • Living in Canada

Exclusion Criteria:

  • Type 2 diabetes
  • Gestational diabetes

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Participants aged less than 14 years old
Other: 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.
Other: Continuous glucose monitor
Participants will be invited to send us the latest report of their continuous glucose monitor
Participants aged 14 years old and older
Other: Online questionnaire - Phase 2
Characterize the causes, experience and consequences of hypoglycemia.
Other: 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.
Other: Food questionnaire
24-hour food recall questionnaire
Other: Waist circumference
Participants will be asked to measure their waist circumference
Other: Blood and urine tests
Participants will be invited to send us their latests blood and urine test results.
Other: List of medications
Participants will be invited to send us their list of medications
Other: 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.
Other: Continuous glucose monitor
Participants will be invited to send us the latest report of their continuous glucose monitor
Other: Pedometer
Participants will wear a podometer for 14 consecutives days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of non-severe hypoglycemic episodes
Time Frame: 12 months
Participants will be asked to report the number of non-severe hypoglycemic episodes in the last 12 months in a questionnaire designed by the investigators. The definition of non-severe hypoglycemia is a blood sugar below 3.0 mmol/L that the participant was able to treat himself
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of severe hypoglycemic episodes
Time Frame: 12 months
Participants will be asked to report the number of severe hypoglycemic episodes in the last 12 months in a questionnaire designed by the investigators. The definition of severe hypoglycemia is low blood sugar levels requiring help from another person or use of glucagon or hospitalization or loss of consciousness.
12 months
Fear of hypoglycemia
Time Frame: 6 months
Fear of hypoglycemia will be assessed by the Hypoglycemia Fear Survey II.
6 months
Diabetes distress
Time Frame: 1 month
Diabetes distress will be assessed by the Diabetes Distress Scale.
1 month
Medical follow-up for diabetes
Time Frame: 12 months
Participants will be asked to report in a questionnaire designed by the investigators how many times in the last 12 months they have seen a health care professionals (family doctor, medical specialist, nurse, nutritionnist, kinesiologist, psychologist, pharmacist, social worker).
12 months
Insulin doses
Time Frame: 3 days
Participants will be asked to report in a questionnaire designed by the investigators their insulin doses of the last 3 days (basal insulin and insulin given at mealtime).
3 days
Physical activity
Time Frame: 1 week
Physical activity will be assessed by the International Physical Activity Questionnaire.
1 week
Sleep habits
Time Frame: 1 month
Sleep habits will be assessed by the Pittsburgh Sleep Quality Index
1 month
Depression
Time Frame: 2 weeks
Depression will be assessed by the Patient Health Questionnaire (PHQ-9)
2 weeks
Number of steps
Time Frame: 14 days
The number of steps will be measured by a pedometer
14 days

Collaborators and Investigators

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

Sponsor

Institut de Recherches Cliniques de Montreal

Investigators

  • Principal Investigator: Remi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal

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)

February 20, 2019

Primary Completion (Estimated)

March 31, 2026

Study Completion (Estimated)

March 31, 2026

Study Registration Dates

First Submitted

October 19, 2018

First Submitted That Met QC Criteria

October 22, 2018

First Posted (Actual)

October 25, 2018

Study Record Updates

Last Update Posted (Actual)

December 28, 2023

Last Update Submitted That Met QC Criteria

December 21, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BETTER

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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