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Registry of Patients Living With Type 1 Diabetes

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03720197
Enrollment
6000
Registered
2018-10-25
Start date
2019-02-20
Completion date
2027-03-31
Last updated
2025-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes Mellitus

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.

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

Interventions

OTHEROnline 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.

OTHEROnline questionnaire - Phase 2

Characterize the causes, experience and consequences of hypoglycemia.

OTHEROnline 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.

24-hour food recall questionnaire

OTHERPedometer

Participants will wear a podometer for 14 consecutives days

Participants will be asked to measure their waist circumference

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

OTHERList of medications

Participants will be invited to send us their list of medications

OTHERContinuous glucose monitor

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

Sponsors

Institut de Recherches Cliniques de Montreal
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Diagnosis of type 1 diabetes * Living in Canada

Exclusion criteria

* Type 2 diabetes * Gestational diabetes

Design outcomes

Primary

MeasureTime frameDescription
Number of non-severe hypoglycemic episodes12 monthsParticipants 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

MeasureTime frameDescription
Fear of hypoglycemia6 monthsFear of hypoglycemia will be assessed by the Hypoglycemia Fear Survey II.
Diabetes distress1 monthDiabetes distress will be assessed by the Diabetes Distress Scale.
Medical follow-up for diabetes12 monthsParticipants 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).
Insulin doses3 daysParticipants 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).
Number of severe hypoglycemic episodes12 monthsParticipants 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.
Sleep habits1 monthSleep habits will be assessed by the Pittsburgh Sleep Quality Index
Depression2 weeksDepression will be assessed by the Patient Health Questionnaire (PHQ-9)
Number of steps14 daysThe number of steps will be measured by a pedometer
Physical activity1 weekPhysical activity will be assessed by the International Physical Activity Questionnaire.

Countries

Canada

Contacts

Primary ContactVirginie Messier
virginie.messier@ircm.qc.ca514-987-5500

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026