Registry of Patients Living With Type 1 Diabetes
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| ClinicalTrials.gov Identifier: NCT03720197 |
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Recruitment Status :
Recruiting
First Posted : October 25, 2018
Last Update Posted : July 28, 2021
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A registry of individuals with type 1 diabetes open to all patients with type 1 diabetes living in the province of Quebec 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.
| Condition or disease | Intervention/treatment |
|---|---|
| Type 1 Diabetes Mellitus | Other: Online questionnaire - Phase 1 Other: Online questionnaire - Phase 2 Other: Online questionnaire - Phase 3 Other: Food questionnaire Other: Podometer Other: Waist circumference Other: Blood and urine tests Other: List of medications |
The objective of phase 1 is to draw an overall picture of the population with type 1 diabetes in Quebec in terms of demographics, diabetes treatment, hypoglycemia frequency and diabetes complications. It will take you about 10 minutes to answer the questionnaire.
The objective of phase 2 is to characterize the causes, experience and consequences of hypoglycemia.
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 answering a food questionnaire, wearing a step counter, measuring waist circumference and if the participant accepts to provide the research team with their latest blood and urine tests as well as their list of medications.
| Study Type : | Observational [Patient Registry] |
| Estimated Enrollment : | 12000 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 4 Years |
| Official Title: | Registry of Individuals With Type 1 Diabetes Living in Quebec: The BETTER Registry |
| Actual Study Start Date : | February 20, 2019 |
| Estimated Primary Completion Date : | March 31, 2024 |
| Estimated Study Completion Date : | March 31, 2024 |
| Group/Cohort | Intervention/treatment |
|---|---|
| Participants aged less than 14 years old |
Other: Online questionnaire - Phase 1
Draw an overall picture of the population with type 1 diabetes in Quebec in terms of demographics, diabetes treatment, hypoglycemia frequency and diabetes complications. |
| Participants aged 14 years old and older |
Other: Online questionnaire - Phase 1
Draw an overall picture of the population with type 1 diabetes in Quebec in terms of demographics, diabetes treatment, hypoglycemia frequency and diabetes complications. Other: Online questionnaire - Phase 2 Characterize the causes, experience and consequences of hypoglycemia. 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. Other: Food questionnaire 24-hour food recall questionnaire Other: Podometer Participants will wear a podometer for 14 consecutives days Other: Waist circumference Participants will be asked to measure their waist circumference Other: Blood and urine tests Participants will be invited to send us their latests blood and urine test results. Other: List of medications Participants will be invited to send us their list of medications |
- Number of non-severe hypoglycemic episodes [ Time Frame: 12 months ]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
- Number of severe hypoglycemic episodes [ Time Frame: 12 months ]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.
- Fear of hypoglycemia [ Time Frame: 6 months ]Fear of hypoglycemia will be assessed by the Hypoglycemia Fear Survey II.
- Diabetes distress [ Time Frame: 1 month ]Diabetes distress will be assessed by the Diabetes Distress Scale.
- Medical follow-up for diabetes [ Time Frame: 12 months ]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).
- Insulin doses [ Time Frame: 3 days ]Participants will be asked to report in a questionnaire designed by the investigators their insulin doses of the last 3 days (basal insulin and insulin given at mealtime).
- Physical activity [ Time Frame: 1 week ]Physical activity will be assessed by the International Physical Activity Questionnaire.
- Sleep habits [ Time Frame: 1 month ]Sleep habits will be assessed by the Pittsburgh Sleep Quality Index
- Depression [ Time Frame: 2 weeks ]Depression will be assessed by the Patient Health Questionnaire (PHQ-9)
- Number of steps [ Time Frame: 14 days ]The number of steps will be measured by a pedometer
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Diagnosis of type 1 diabetes
- Living in the province of Quebec (Canada)
Exclusion Criteria:
- Type 2 diabetes
- Gestational diabetes
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03720197
| Contact: Virginie Messier | 514-987-5500 ext 3227 | virginie.messier@ircm.qc.ca |
| Canada, Quebec | |
| Institut de recherches cliniques de Montréal | Recruiting |
| Montreal, Quebec, Canada, H7K3Y8 | |
| Contact: Virginie Messier 514-987-5500 ext 3227 virginie.messier@ircm.qc.ca | |
| Principal Investigator: Remi Rabasa-Lhoret | |
| Canada | |
| Centre Hospitalier de l'Université de Montréal | Recruiting |
| Montreal, Canada | |
| Contact: Remi Rabasa-Lhoret 514-987-5500 ext 3227 remi.rabasa-lhoret@ircm.qc.ca | |
| Principal Investigator: Remi Rabasa-Lhoret | |
| Centre Hospitalier Universitaire Sainte-Justine | Not yet recruiting |
| Montreal, Canada | |
| Contact: Catherine Pelletier catherine.pelletier@recherche-ste-justine.qc.ca | |
| Principal Investigator: Melanie Henderson | |
| McGill University Health Centre | Not yet recruiting |
| Montreal, Canada | |
| Contact: Laurent Legault laurent.legault@muhc.mcgill.ca | |
| Principal Investigator: Laurent Legault | |
| Sub-Investigator: Kaberi Dasgupta | |
| Sub-Investigator: Meranda Nakhla | |
| Centre Hospitalier Universitaire de Québec-Université Laval | Not yet recruiting |
| Quebec, Canada | |
| Contact: Claudia Gagnon claudia.gagnon@crchudequebec.ulaval.ca | |
| Principal Investigator: Claudia Gagnon | |
| Centre hospitalier universitaire de Sherbrooke | Not yet recruiting |
| Sherbrooke, Canada | |
| Contact: Andre Carpentier andre.carpentier@usherbrooke.ca | |
| Principal Investigator: Andre Carpentier | |
| Principal Investigator: | Remi Rabasa-Lhoret | Institut de recherches cliniques de Montréal |
| Responsible Party: | Rémi Rabasa-Lhoret, Full professor, Institut de Recherches Cliniques de Montreal |
| ClinicalTrials.gov Identifier: | NCT03720197 |
| Other Study ID Numbers: |
BETTER |
| First Posted: | October 25, 2018 Key Record Dates |
| Last Update Posted: | July 28, 2021 |
| Last Verified: | July 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Autoimmune Diseases Immune System Diseases |