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Registry of Patients Living with Type 1 Diabetes

I

Institut de Recherches Cliniques de Montreal

Status

Enrolling

Conditions

Type 1 Diabetes Mellitus

Treatments

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

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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

Enrollment

6,000 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Diagnosis of type 1 diabetes
  • Living in Canada

Exclusion criteria

  • Type 2 diabetes
  • Gestational diabetes

Trial design

6,000 participants in 2 patient groups

Participants aged less than 14 years old
Treatment:
Other: Online questionnaire - Phase 1
Other: Continuous glucose monitor
Participants aged 14 years old and older
Treatment:
Other: Waist circumference
Other: Online questionnaire - Phase 1
Other: Food questionnaire
Other: Online questionnaire - Phase 3
Other: List of medications
Other: Pedometer
Other: Continuous glucose monitor
Other: Blood and urine tests
Other: Online questionnaire - Phase 2

Trial contacts and locations

7

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Central trial contact

Virginie Messier

Data sourced from clinicaltrials.gov

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