Registry of Patients Living With Type 1 Diabetes

Type 1 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03720197
• Other study ID #: BETTER
• Status: Recruiting
• Start date: February 20, 2019
• Est. completion date: March 31, 2026

Study information

• Verified date: December 2023
• Source: Institut de Recherches Cliniques de Montreal
• Contact: Virginie Messier
• Phone: 514-987-5500
• Email: virginie.messier[@]ircm.qc.ca
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6000
• Est. completion date: March 31, 2026
• Est. primary completion date: March 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Diagnosis of type 1 diabetes

• Living in Canada

Exclusion Criteria:

• Type 2 diabetes

• Gestational diabetes

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

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.
• 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

Locations

Country	Name	City	State
Canada	Alberta Diabetes Institute	Edmonton	Alberta
Canada	Centre Hospitalier de l'Université de Montréal	Montreal	Quebec
Canada	Centre Hospitalier Universitaire Sainte-Justine	Montreal	Quebec
Canada	Institut de recherches cliniques de Montréal	Montreal	Quebec
Canada	McGill University Health Centre	Montreal	Quebec
Canada	Centre Hospitalier Universitaire de Québec-Université Laval	Quebec
Canada	Centre hospitalier universitaire de Sherbrooke	Sherbrooke	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Institut de Recherches Cliniques de Montreal

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of non-severe hypoglycemic episodes	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	Number of severe hypoglycemic episodes	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
Secondary	Fear of hypoglycemia	Fear of hypoglycemia will be assessed by the Hypoglycemia Fear Survey II.	6 months
Secondary	Diabetes distress	Diabetes distress will be assessed by the Diabetes Distress Scale.	1 month
Secondary	Medical follow-up for diabetes	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
Secondary	Insulin doses	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
Secondary	Physical activity	Physical activity will be assessed by the International Physical Activity Questionnaire.	1 week
Secondary	Sleep habits	Sleep habits will be assessed by the Pittsburgh Sleep Quality Index	1 month
Secondary	Depression	Depression will be assessed by the Patient Health Questionnaire (PHQ-9)	2 weeks
Secondary	Number of steps	The number of steps will be measured by a pedometer	14 days