Registry of Patients Living With Type 1 Diabetes

Официальное название

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

Обзор

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.

Подробное описание

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

Вмешательства

• Другое 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.
• Другое Online questionnaire - Phase 2
  Characterize the causes, experience and consequences of hypoglycemia.
• Другое 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.
• Другое Food questionnaire
  24-hour food recall questionnaire
• Другое Pedometer
  Participants will wear a podometer for 14 consecutives days
• Другое Waist circumference
  Participants will be asked to measure their waist circumference
• Другое Blood and urine tests
  Participants will be invited to send us their latests blood and urine test results.
• Другое List of medications
  Participants will be invited to send us their list of medications
• Другое Continuous glucose monitor
  Participants will be invited to send us the latest report of their continuous glucose monitor

Первичные конечные точки

• Number of non-severe hypoglycemic episodes [Срок оценки: 12 months]

Вторичные конечные точки (9)

• Number of severe hypoglycemic episodes [Срок оценки: 12 months]
• Fear of hypoglycemia [Срок оценки: 6 months]
• Diabetes distress [Срок оценки: 1 month]
• Medical follow-up for diabetes [Срок оценки: 12 months]
• Insulin doses [Срок оценки: 3 days]
• Physical activity [Срок оценки: 1 week]
• Sleep habits [Срок оценки: 1 month]
• Depression [Срок оценки: 2 weeks]
• Number of steps [Срок оценки: 14 days]

Критерии участия

Критерии включения

• Diagnosis of type 1 diabetes
• Living in Canada

Критерии исключения

• Type 2 diabetes
• Gestational diabetes

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Канада · 7 центров

• Alberta Diabetes Institute — Edmonton
• Institut de recherches cliniques de Montréal — Montreal
• Centre Hospitalier de l'Université de Montréal — Montreal
• Centre Hospitalier Universitaire Sainte-Justine — Montreal
• McGill University Health Centre — Montreal
• Centre Hospitalier Universitaire de Québec-Université Laval — Québec
• Centre hospitalier universitaire de Sherbrooke — Sherbrooke

Публикации

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT03720197 · BETTER

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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