Registry of Patients Living with Type 1 Diabetes

Recruiting

• Conditions: Type 1 Diabetes Mellitus

• Registration Number: NCT03720197
• Lead Sponsor: Institut de Recherches Cliniques de Montreal

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

Study Timeline

• Study First Submitted: 2018-10-19
• Study First Submitted QC: 2018-10-22
• Study First Posted: 2018-10-25
• Study Start: 2019-02-20
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-02-25
• Primary Completion: 2027-03-31
• Study Completion: 2027-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 6000

Inclusion Criteria

• Diagnosis of type 1 diabetes
• Living in Canada

Exclusion Criteria

• Type 2 diabetes
• Gestational diabetes

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of non-severe hypoglycemic episodes	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 Outcome Measures

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

Trial Locations

Locations (7)

Alberta Diabetes Institute; 🇨🇦 Edmonton, Alberta, Canada

Institut de recherches cliniques de Montréal; 🇨🇦 Montreal, Quebec, Canada

Centre Hospitalier de l'Université de Montréal; 🇨🇦 Montreal, Quebec, Canada

Centre Hospitalier Universitaire Sainte-Justine; 🇨🇦 Montreal, Quebec, Canada

McGill University Health Centre; 🇨🇦 Montreal, Quebec, Canada

Centre hospitalier universitaire de Sherbrooke; 🇨🇦 Sherbrooke, Quebec, Canada

Centre Hospitalier Universitaire de Québec-Université Laval; 🇨🇦 Quebec, Canada