Registry of Patients Living With Type 1 Diabetes

NCT03720197 | Recruiting

• 1 other identifier: BETTER
• Study Type: observational
• Target: 6,000
• Locations: 1 country
• Sites: 7

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.

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

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

  12 months

Secondary Outcomes (9)

• Number of severe hypoglycemic episodes

  12 months

• Fear of hypoglycemia

  6 months

• Diabetes distress

  1 month

• Medical follow-up for diabetes

  12 months

• Insulin doses

  3 days

Study Arms (2)

Participants aged less than 14 years old

Other: Online questionnaire - Phase 1; Other: Continuous glucose monitor

Participants aged 14 years old and older

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

Interventions

Online questionnaire - Phase 1 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.

Participants aged 14 years old and older; Participants aged less than 14 years old

Online questionnaire - Phase 2 OTHER

Characterize the causes, experience and consequences of hypoglycemia.

Participants aged 14 years old and older

Online questionnaire - Phase 3 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.

Participants aged 14 years old and older

Food questionnaire OTHER

24-hour food recall questionnaire

Participants aged 14 years old and older

Pedometer OTHER

Participants will wear a podometer for 14 consecutives days

Participants aged 14 years old and older

Waist circumference OTHER

Participants will be asked to measure their waist circumference

Participants aged 14 years old and older

Blood and urine tests OTHER

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

Participants aged 14 years old and older

List of medications OTHER

Participants will be invited to send us their list of medications

Participants aged 14 years old and older

Continuous glucose monitor OTHER

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

Participants aged 14 years old and older; Participants aged less than 14 years old

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals with type 1 diabetes living in Canada.

You may qualify if:

• Diagnosis of type 1 diabetes
• Living in Canada

You may not qualify if:

• Type 2 diabetes
• Gestational diabetes

Sponsors & Collaborators

• Institut de Recherches Cliniques de Montreal: lead

Study Sites (7)

Alberta Diabetes Institute

Edmonton, Alberta, T6G 2T9, Canada

RECRUITING

Institut de recherches cliniques de Montréal

Montreal, Quebec, H2W 1R7, Canada

RECRUITING

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

RECRUITING

Centre Hospitalier Universitaire Sainte-Justine

Montreal, Quebec, Canada

RECRUITING

McGill University Health Centre

Montreal, Quebec, Canada

RECRUITING

Centre Hospitalier Universitaire de Québec-Université Laval

Québec, Quebec, Canada

RECRUITING

Centre hospitalier universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

RECRUITING

Related Publications (12)

• 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.

  PMID: 39236506 BACKGROUND

• 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.

  PMID: 39193662 BACKGROUND

• 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.

  PMID: 37059389 BACKGROUND

• 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.

  PMID: 37952601 BACKGROUND

• 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.

  PMID: 37423499 BACKGROUND

• 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.

  PMID: 34509633 BACKGROUND

• 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.

  PMID: 38866607 BACKGROUND

• 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.

  PMID: 35864032 BACKGROUND

• 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.

  PMID: 36099973 BACKGROUND

• 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.

  PMID: 35045175 BACKGROUND

• 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.

  PMID: 36245008 DERIVED

• 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.

  PMID: 35835670 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Waist Circumference; Blood Specimen Collection; Urinalysis

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Body Size; Body Weights and Measures; Body Constitution; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Anthropometry; Investigative Techniques; Physiological Phenomena; Specimen Handling; Clinical Laboratory Techniques; Punctures; Surgical Procedures, Operative; Clinical Chemistry Tests; Diagnostic Techniques, Urological

Study Officials

• Remi Rabasa-Lhoret

  Institut de recherches cliniques de Montréal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Virginie Messier

CONTACT

514-987-5500; virginie.messier@ircm.qc.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full professor

Study Record Dates

• First Submitted: October 19, 2018
• First Posted: October 25, 2018
• Study Start: February 20, 2019
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: February 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (7)