Type 1 Diabetes MellitusNCT03720197
Registry of Patients Living With Type 1 Diabetes
An observational study of Type 1 Diabetes Mellitus, run by Institut de Recherches Cliniques de Montreal at 7 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Online questionnaire - Phase 1, Online questionnaire - Phase 2 and Online questionnaire - Phase 3
- How many people
- 6,000 participants
- Where
- 7 sitesCanada
- Study dates
- 20 Feb 2019to 31 Mar 2027
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Individuals with type 1 diabetes living in Canada.
Who may be able to join
- Diagnosis of type 1 diabetes
- Living in Canada
Who cannot join
- Type 2 diabetes
- Gestational diabetes
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Canada7 sites, 7 recruiting
- Recruiting
Alberta Diabetes Institute
Edmonton, Alberta, T6G 2T9
Jyoti Singh
Peter Senior
- Recruiting
Institut de recherches cliniques de Montréal
Montreal, Quebec, H2W 1R7
Virginie Messier, 514-987-5696, virginie.messier@ircm.qc.ca
Remi Rabasa-Lhoret
- Recruiting
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec
Remi Rabasa-Lhoret, 514-987-5696, remi.rabasa-lhoret@ircm.qc.ca
Remi Rabasa-Lhoret
- Recruiting
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec
Catherine Pelletier, catherine.pelletier@recherche-ste-justine.qc.ca
Melanie Henderson
- Recruiting
McGill University Health Centre
Montreal, Quebec
Laurent Legault, laurent.legault@muhc.mcgill.ca
Laurent Legault
- Recruiting
Centre Hospitalier Universitaire de Québec-Université Laval
Québec, Quebec
Claudia Gagnon, claudia.gagnon@crchudequebec.ulaval.ca
Claudia Gagnon
- Recruiting
Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec
Andre Carpentier, andre.carpentier@usherbrooke.ca
Andre Carpentier
About this study
Official title: Registry of Individuals With Type 1 Diabetes Living in Canada: The BETTER Registry
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.
Read the detailed description
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
- Type 1 Diabetes Mellitus
- Being tested
- Online questionnaire - Phase 1, Online questionnaire - Phase 2, Online questionnaire - Phase 3, Food questionnaire, Pedometer
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online questionnaire - Phase 1Other
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 2Other
Characterize the causes, experience and consequences of hypoglycemia.
Online questionnaire - Phase 3Other
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 questionnaireOther
24-hour food recall questionnaire
PedometerOther
Participants will wear a podometer for 14 consecutives days
Waist circumferenceOther
Participants will be asked to measure their waist circumference
Blood and urine testsOther
Participants will be invited to send us their latests blood and urine test results.
List of medicationsOther
Participants will be invited to send us their list of medications
Continuous glucose monitorOther
Participants will be invited to send us the latest report of their continuous glucose monitor
| Study group | Role | What they receive |
|---|---|---|
| Participants aged less than 14 years old | Not described Receives: Other: Online questionnaire - Phase 1; Other: Continuous glucose monitor | |
| Participants aged 14 years old and older | Not described Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (9)
Number of severe hypoglycemic episodes
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.
Measured: 12 months
Fear of hypoglycemia
Fear of hypoglycemia will be assessed by the Hypoglycemia Fear Survey II.
Measured: 6 months
Diabetes distress
Diabetes distress will be assessed by the Diabetes Distress Scale.
Measured: 1 month
Medical follow-up for diabetes
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).
Measured: 12 months
Insulin doses
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).
Measured: 3 days
Physical activity
Physical activity will be assessed by the International Physical Activity Questionnaire.
Measured: 1 week
Sleep habits
Sleep habits will be assessed by the Pittsburgh Sleep Quality Index
Measured: 1 month
Depression
Depression will be assessed by the Patient Health Questionnaire (PHQ-9)
Measured: 2 weeks
Number of steps
The number of steps will be measured by a pedometer
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start20 Feb 2019
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Institut de Recherches Cliniques de Montreal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rémi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal
- Investigators
- Remi Rabasa-Lhoret, Principal investigator, Institut de Recherches Cliniques de Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03720197
- Sponsor's protocol ID
- BETTER
- Status last verified
- Feb 2025
- First submitted
- 19 Oct 2018
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39236506Lalanne-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.
PubMed 39193662Madar 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.
PubMed 37059389Wu 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.
PubMed 37952601Talbo 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.
PubMed 37423499Wu 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.
PubMed 34509633Nguyen 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.
PubMed 38866607Talbo 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.
PubMed 35864032Talbo 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.
PubMed 36099973Prevost 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.
PubMed 35045175Madar 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.
PubMed 36245008Brazeau 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.
PubMed 35835670
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry of Individuals With Type 1 Diabetes Living in Canada: The BETTER Registry
- ClinicalTrials.gov ID
- NCT03720197
- Acronym / sponsor ID
- BETTER
- Conditions
- Type 1 Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Institut de Recherches Cliniques de MontrealUniversity, hospital or other
- Study start
- 20 Feb 2019 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 25 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Individuals with type 1 diabetes living in Canada.
Key inclusion criteria (2 listed)
- Diagnosis of type 1 diabetes
- Living in Canada
Key exclusion criteria (2 listed)
- Type 2 diabetes
- Gestational diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online questionnaire - Phase 1Draw an overall picture of the population with type 1 diabetes in Canada in terms of demographics, diabetes treatment, hypoglycemia frequency and diabetes complications. | Other | Participants aged 14 years old and older, Participants aged less than 14 years old |
| Online questionnaire - Phase 2Characterize the causes, experience and consequences of hypoglycemia. | Other | Participants aged 14 years old and older |
| Online questionnaire - Phase 3Collect 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 | Participants aged 14 years old and older |
| Food questionnaire24-hour food recall questionnaire | Other | Participants aged 14 years old and older |
| PedometerParticipants will wear a podometer for 14 consecutives days | Other | Participants aged 14 years old and older |
| Waist circumferenceParticipants will be asked to measure their waist circumference | Other | Participants aged 14 years old and older |
| Blood and urine testsParticipants will be invited to send us their latests blood and urine test results. | Other | Participants aged 14 years old and older |
| List of medicationsParticipants will be invited to send us their list of medications | Other | Participants aged 14 years old and older |
| Continuous glucose monitorParticipants will be invited to send us the latest report of their continuous glucose monitor | Other | Participants aged 14 years old and older, Participants aged less than 14 years old |
Primary outcome
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
9 secondary outcomes
Number of severe hypoglycemic episodes
Time frame: 12 months
Fear of hypoglycemia
Time frame: 6 months
Diabetes distress
Time frame: 1 month
Medical follow-up for diabetes
Time frame: 12 months
Insulin doses
Time frame: 3 days
Physical activity
Time frame: 1 week
Sleep habits
Time frame: 1 month
Depression
Time frame: 2 weeks
Number of steps
Time frame: 14 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Results publication: PubMed 39236506Housni 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.
- Results publication: PubMed 39193662Lalanne-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.
- Results publication: PubMed 37059389Madar 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.
- Results publication: PubMed 37952601Wu 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.
- Results publication: PubMed 37423499Talbo 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.
- Results publication: PubMed 34509633Wu 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.
- Results publication: PubMed 38866607Nguyen 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.
- Results publication: PubMed 35864032Talbo 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.
- Results publication: PubMed 36099973Talbo 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.
- Results publication: PubMed 35045175Prevost 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.
- Derived from this study: PubMed 36245008Madar 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.
- Derived from this study: PubMed 35835670Brazeau 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Remi Rabasa-Lhoret principal investigator
Institut de Recherches Cliniques de Montreal
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes Mellitus, run by Institut de Recherches Cliniques de Montreal at 7 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Virginie Messier (514-987-5500 ext. 3227, virginie.messier@ircm.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of non-severe hypoglycemic episodes (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03720197, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.