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NCT Number: NCT03720197

Registry of Patients Living With Type 1 Diabetes

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.

Recruiting

Interested in participating?

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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Alberta Diabetes Institute, Edmonton, Alberta, Canada

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of type 1 diabetes
  • Living in Canada

Exclusion criteria

  • Type 2 diabetes
  • Gestational diabetes

Treatment and study plan

Online questionnaire - Phase 1

Other

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

Other

Characterize the causes, experience and consequences of hypoglycemia.

Online questionnaire - Phase 3

Other

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

Other

24-hour food recall questionnaire

Pedometer

Other

Participants will wear a podometer for 14 consecutives days

Waist Circumference

Other

Participants will be asked to measure their waist circumference

Blood and urine tests

Other

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

List of medications

Other

Participants will be invited to send us their list of medications

Continuous Glucose Monitor

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. Fear of hypoglycemia

    Time frame: 6 months

    Fear of hypoglycemia will be assessed by the Hypoglycemia Fear Survey II.

  3. Diabetes distress

    Time frame: 1 month

    Diabetes distress will be assessed by the Diabetes Distress Scale.

  4. 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).

  5. 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).

  6. Physical activity

    Time frame: 1 week

    Physical activity will be assessed by the International Physical Activity Questionnaire.

  7. Sleep habits

    Time frame: 1 month

    Sleep habits will be assessed by the Pittsburgh Sleep Quality Index

  8. Depression

    Time frame: 2 weeks

    Depression will be assessed by the Patient Health Questionnaire (PHQ-9)

  9. Number of steps

    Time frame: 14 days

    The number of steps will be measured by a pedometer

Study contacts

Contact information is provided by the study sponsor or research team.

Virginie Messier

CONTACT

[email protected]

514-987-5500 ext. 3227

Sponsors and collaborators

Lead sponsor

Institut de Recherches Cliniques de Montreal

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Oct 25, 2018
Registry last updated
Feb 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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