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Registry of Patients Living With Type 1 Diabetes

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ClinicalTrials.gov Identifier: NCT03720197
Recruitment Status : Recruiting
First Posted : October 25, 2018
Last Update Posted : March 28, 2019
Sponsor:
Information provided by (Responsible Party):
Rémi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal

Brief Summary:

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

Detailed Description:

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.


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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, 2022
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. Fear of hypoglycemia [ Time Frame: 6 months ]
    Fear of hypoglycemia will be assessed by the Hypoglycemia Fear Survey II.

  3. Diabetes distress [ Time Frame: 1 month ]
    Diabetes distress will be assessed by the Diabetes Distress Scale.

  4. 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).

  5. 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).

  6. Physical activity [ Time Frame: 1 week ]
    Physical activity will be assessed by the International Physical Activity Questionnaire.

  7. Sleep habits [ Time Frame: 1 month ]
    Sleep habits will be assessed by the Pittsburgh Sleep Quality Index

  8. Depression [ Time Frame: 2 weeks ]
    Depression will be assessed by the Patient Health Questionnaire (PHQ-9)

  9. Number of steps [ Time Frame: 14 days ]
    The number of steps will be measured by a pedometer



Information from the National Library of Medicine

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.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Individuals with type 1 diabetes living in the province of Quebec.
Criteria

Inclusion Criteria:

  • Diagnosis of type 1 diabetes
  • Living in the province of Quebec (Canada)

Exclusion Criteria:

  • Type 2 diabetes
  • Gestational diabetes

Information from the National Library of Medicine

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


Contacts
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Contact: Virginie Messier 514-987-5500 ext 3227 virginie.messier@ircm.qc.ca

Locations
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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         
Sponsors and Collaborators
Institut de Recherches Cliniques de Montreal
Investigators
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Principal Investigator: Remi Rabasa-Lhoret Institut de recherches cliniques de Montréal

Additional Information:

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Responsible Party: Rémi Rabasa-Lhoret, Full professor, Institut de Recherches Cliniques de Montreal
ClinicalTrials.gov Identifier: NCT03720197     History of Changes
Other Study ID Numbers: BETTER
First Posted: October 25, 2018    Key Record Dates
Last Update Posted: March 28, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases