Registry of Patients Living With Type 1 Diabetes

NCT ID: NCT03720197

Last Updated: 2025-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

6000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-20

Study Completion Date

2027-03-31

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

Conditions

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Type 1 Diabetes Mellitus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants aged less than 14 years old

Online questionnaire - Phase 1

Intervention Type OTHER

Draw an overall picture of the population with type 1 diabetes in Canada in terms of demographics, diabetes treatment, hypoglycemia frequency and diabetes complications.

Continuous glucose monitor

Intervention Type OTHER

Participants will be invited to send us the latest report of their continuous glucose monitor

Participants aged 14 years old and older

Online questionnaire - Phase 1

Intervention Type OTHER

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

Intervention Type OTHER

Characterize the causes, experience and consequences of hypoglycemia.

Online questionnaire - Phase 3

Intervention Type OTHER

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

Intervention Type OTHER

24-hour food recall questionnaire

Pedometer

Intervention Type OTHER

Participants will wear a podometer for 14 consecutives days

Waist circumference

Intervention Type OTHER

Participants will be asked to measure their waist circumference

Blood and urine tests

Intervention Type OTHER

Participants will be invited to send us their latests blood and urine test results.

List of medications

Intervention Type OTHER

Participants will be invited to send us their list of medications

Continuous glucose monitor

Intervention Type OTHER

Participants will be invited to send us the latest report of their continuous glucose monitor

Interventions

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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.

Intervention Type OTHER

Online questionnaire - Phase 2

Characterize the causes, experience and consequences of hypoglycemia.

Intervention Type OTHER

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.

Intervention Type OTHER

Food questionnaire

24-hour food recall questionnaire

Intervention Type OTHER

Pedometer

Participants will wear a podometer for 14 consecutives days

Intervention Type OTHER

Waist circumference

Participants will be asked to measure their waist circumference

Intervention Type OTHER

Blood and urine tests

Participants will be invited to send us their latests blood and urine test results.

Intervention Type OTHER

List of medications

Participants will be invited to send us their list of medications

Intervention Type OTHER

Continuous glucose monitor

Participants will be invited to send us the latest report of their continuous glucose monitor

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of type 1 diabetes
* Living in Canada

Exclusion Criteria

* Type 2 diabetes
* Gestational diabetes
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut de Recherches Cliniques de Montreal

OTHER

Sponsor Role lead

Responsible Party

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Rémi Rabasa-Lhoret

Full professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Remi Rabasa-Lhoret

Role: PRINCIPAL_INVESTIGATOR

Institut de recherches cliniques de Montréal

Locations

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Alberta Diabetes Institute

Edmonton, Alberta, Canada

Site Status RECRUITING

Institut de recherches cliniques de Montréal

Montreal, Quebec, Canada

Site Status RECRUITING

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

Site Status RECRUITING

Centre Hospitalier Universitaire Sainte-Justine

Montreal, Quebec, Canada

Site Status RECRUITING

McGill University Health Centre

Montreal, Quebec, Canada

Site Status RECRUITING

Centre Hospitalier Universitaire de Québec-Université Laval

Québec, Quebec, Canada

Site Status RECRUITING

Centre hospitalier universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Virginie Messier

Role: CONTACT

514-987-5500 ext. 3227

Facility Contacts

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Jyoti Singh

Role: primary

Virginie Messier

Role: primary

514-987-5696

Remi Rabasa-Lhoret

Role: primary

514-987-5696

Catherine Pelletier

Role: primary

Laurent Legault

Role: primary

Claudia Gagnon

Role: primary

Andre Carpentier

Role: primary

References

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Housni A, Katz A, Kichler JC, Nakhla M, Secours L, Brazeau AS. Predictors of stigma perception by people with type 1 diabetes: A cross-sectional analysis of the BETTER registry. Diabetes Metab Syndr. 2024 Aug;18(8):103112. doi: 10.1016/j.dsx.2024.103112. Epub 2024 Aug 29.

Reference Type BACKGROUND
PMID: 39236506 (View on PubMed)

Lalanne-Mistrih ML, Bonhoure A, Messier V, Boudreau V, Lebbar M, Talbo MK, Sun CJ, Bandini A, Secours L, Calderon V, Grou C, Tressieres B, Brazeau AS, Rabasa-Lhoret R. Overweight and Obesity in People Living With Type 1 Diabetes: A Cross-Sectional Analysis of the BETTER Registry. Diabetes Metab Res Rev. 2024 Sep;40(6):e3837. doi: 10.1002/dmrr.3837.

Reference Type BACKGROUND
PMID: 39193662 (View on PubMed)

Madar H, Lalanne-Mistrih ML, Lebbar M, Wu Z, Robitaille Y, Pelletier J, Grou C, Brazeau AS, Rabasa-Lhoret R. Cardiovascular Risk Factors and Adherence to Cardiovascular Protection Practice Guidelines in Adults With Type 1 Diabetes: A BETTER Registry Cross-sectional Analysis. Can J Diabetes. 2023 Aug;47(6):473-481.e1. doi: 10.1016/j.jcjd.2023.04.006. Epub 2023 Apr 12.

Reference Type BACKGROUND
PMID: 37059389 (View on PubMed)

Wu Z, Talbo M, Lebbar M, Messier V, Courchesne A, Brazeau AS, Rabasa-Lhoret R. Characteristics associated with having a hemoglobin A1c </= 7 % (</=53 mmol/mol) among adults with type 1 diabetes using an automated insulin delivery system. Diabetes Res Clin Pract. 2023 Dec;206:111006. doi: 10.1016/j.diabres.2023.111006. Epub 2023 Nov 10.

Reference Type BACKGROUND
PMID: 37952601 (View on PubMed)

Talbo MK, Lebbar M, Wu Z, Vanasse A, Lalanne-Mistrih ML, Brazeau AS, Rabasa-Lhoret R. Gender differences in reported frequency and consequences of hypoglycemia among adults living with type 1 diabetes: Results from the BETTER registry. Diabetes Res Clin Pract. 2023 Aug;202:110822. doi: 10.1016/j.diabres.2023.110822. Epub 2023 Jul 7.

Reference Type BACKGROUND
PMID: 37423499 (View on PubMed)

Wu Z, Rabasa-Lhoret R, Messier V, Shohoudi A, Dasgupta K, Pelletier J, Brazeau AS. Self-reported haemoglobin A1c highly agrees with laboratory-measured haemoglobin A1c among adults living with type 1 diabetes: A BETTER registry study. Diabetes Metab. 2022 Jan;48(1):101277. doi: 10.1016/j.diabet.2021.101277. Epub 2021 Sep 9. No abstract available.

Reference Type BACKGROUND
PMID: 34509633 (View on PubMed)

Nguyen E, Wong K, Lalanne-Mistrih ML, Rabasa-Lhoret R, Brazeau AS. Association between low-carbohydrate-diet score, glycemia and cardiovascular risk factors in adults with type 1 diabetes. Nutr Metab Cardiovasc Dis. 2024 Sep;34(9):2143-2154. doi: 10.1016/j.numecd.2024.04.014. Epub 2024 Apr 27.

Reference Type BACKGROUND
PMID: 38866607 (View on PubMed)

Talbo MK, Katz A, Dostie M, Legault L, Brazeau AS. Associations Between Socioeconomic Status and Patient Experience With Type 1 Diabetes Management and Complications: Cross-sectional Analysis of a Cohort From Quebec, Canada. Can J Diabetes. 2022 Aug;46(6):569-577. doi: 10.1016/j.jcjd.2022.02.008. Epub 2022 Mar 3.

Reference Type BACKGROUND
PMID: 35864032 (View on PubMed)

Talbo MK, Rabasa-Lhoret R, Yale JF, Peters TM, Brazeau AS. Are nocturnal hypoglycemia prevention strategies influenced by diabetes technology usage? A BETTER registry analysis. Diabetes Res Clin Pract. 2022 Sep;191:110080. doi: 10.1016/j.diabres.2022.110080. Epub 2022 Sep 12.

Reference Type BACKGROUND
PMID: 36099973 (View on PubMed)

Prevost MS, Rabasa-Lhoret R, Talbo MK, Yardley JE, Curry EG, Brazeau AS. Gender Differences in Strategies to Prevent Physical Activity-Related Hypoglycemia in Patients With Type 1 Diabetes: A BETTER Study. Diabetes Care. 2022 Mar 1;45(3):e51-e53. doi: 10.2337/dc21-1899. No abstract available.

Reference Type BACKGROUND
PMID: 35045175 (View on PubMed)

Madar H, Wu Z, Bandini A, Perkins B, Messier V, Pomey MP, Brazeau AS, Rabasa-Lhoret R. Influence of severe hypoglycemia definition wording on reported prevalence in adults and adolescents with type 1 diabetes: a cross-sectional analysis from the BETTER patient-engagement registry analysis. Acta Diabetol. 2023 Jan;60(1):93-100. doi: 10.1007/s00592-022-01987-9. Epub 2022 Oct 17.

Reference Type DERIVED
PMID: 36245008 (View on PubMed)

Brazeau AS, Messier V, Talbo MK, Gagnon C, Taleb N, Fortier I, Wu Z, Perkins BA, Carpentier AC, Bandini A, Rabasa-Lhoret R; BETTER Study Group. Self-reported Severe and Nonsevere Hypoglycemia in Type 1 Diabetes: Population Surveillance Through the BETTER Patient Engagement Registry: Development and Baseline Characteristics. Can J Diabetes. 2022 Dec;46(8):813-821. doi: 10.1016/j.jcjd.2022.05.010. Epub 2022 May 28.

Reference Type DERIVED
PMID: 35835670 (View on PubMed)

Other Identifiers

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BETTER

Identifier Type: -

Identifier Source: org_study_id

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