Registry of Patients Living With Type 1 Diabetes
ConditionType 1 Diabetes Mellitus
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorInstitut de Recherches Cliniques de Montreal
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of type 1 diabetes
Living in Canada
Disqualifiers
Type 2 diabetes
Gestational diabetes
Trial population
Individuals with type 1 diabetes living in Canada.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Online questionnaire - Phase 1
Other interventionDraw 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 interventionCharacterize the causes, experience and consequences of hypoglycemia.
Online questionnaire - Phase 3
Other interventionCollect 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 intervention24-hour food recall questionnaire
Pedometer
Other interventionParticipants will wear a podometer for 14 consecutives days
Waist circumference
Other interventionParticipants will be asked to measure their waist circumference
Blood and urine tests
Other interventionParticipants will be invited to send us their latests blood and urine test results.
List of medications
Other interventionParticipants will be invited to send us their list of medications
Continuous glucose monitor
Other interventionParticipants will be invited to send us the latest report of their continuous glucose monitor
Treatment groups
6,000 Participants
are divided into 2 treatment groupsGroup A: Participants aged less than 14 years old2 interventions
Group B: Participants aged 14 years old and older9 interventions
Trial outcomes
Primary outcomes
1
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
Time frame
12 monthsSecondary outcomes
1
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.
Time frame
12 months2
Fear of hypoglycemia
Fear of hypoglycemia will be assessed by the Hypoglycemia Fear Survey II.
Time frame
6 months3
Diabetes distress
Diabetes distress will be assessed by the Diabetes Distress Scale.
Time frame
1 month4
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).
Time frame
12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov