Registry of Patients Living With Type 1 Diabetes

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Type 1 Diabetes Mellitus

Intervention / Treatment
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* Other: Online questionnaire - Phase 1
* Other: Online questionnaire - Phase 2
* Other: Online questionnaire - Phase 3
* Other: Food questionnaire
* Other: Pedometer
* Other: Waist circumference
* Other: Blood and urine tests
* Other: List of medications
* Other: Continuous glucose monitor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of type 1 diabetes Living in Canada Exclusion Criteria: Type 2 diabetes Gestational diabetes
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants aged less than 14 years old<br> | Other: Online questionnaire - Phase 1<br>* Draw an overall picture of the population with type 1 diabetes in Canada in terms of demographics, diabetes treatment, hypoglycemia frequency and diabetes complications.<br>Other: Continuous glucose monitor<br>* Participants will be invited to send us the latest report of their continuous glucose monitor<br>|
| Participants aged 14 years old and older<br> | Other: Online questionnaire - Phase 1<br>* Draw an overall picture of the population with type 1 diabetes in Canada in terms of demographics, diabetes treatment, hypoglycemia frequency and diabetes complications.<br>Other: Online questionnaire - Phase 2<br>* Characterize the causes, experience and consequences of hypoglycemia.<br>Other: Online questionnaire - Phase 3<br>* 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.<br>Other: Food questionnaire<br>* 24-hour food recall questionnaire<br>Other: Pedometer<br>* Participants will wear a podometer for 14 consecutives days<br>Other: Waist circumference<br>* Participants will be asked to measure their waist circumference<br>Other: Blood and urine tests<br>* Participants will be invited to send us their latests blood and urine test results.<br>Other: List of medications<br>* Participants will be invited to send us their list of medications<br>Other: Continuous glucose monitor<br>* Participants will be invited to send us the latest report of their continuous glucose monitor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Fear of hypoglycemia | Fear of hypoglycemia will be assessed by the Hypoglycemia Fear Survey II. | 6 months | 
| Diabetes distress | Diabetes distress will be assessed by the Diabetes Distress Scale. | 1 month | 
| 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 | 
| 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 | 
| Physical activity | Physical activity will be assessed by the International Physical Activity Questionnaire. | 1 week | 
| Sleep habits | Sleep habits will be assessed by the Pittsburgh Sleep Quality Index | 1 month | 
| Depression | Depression will be assessed by the Patient Health Questionnaire (PHQ-9) | 2 weeks | 
| Number of steps | The number of steps will be measured by a pedometer | 14 days |