Type 1 DiabetesNCT06069583
Implementation of Support in the Care of Adults Living With Type 1 Diabetes
A study testing Support platform in people with Type 1 Diabetes and Metabolic Disease, run by McGill University at 4 sites in Canada.
Trial summary
The investigators will conduct a trial to evaluate if an online training and support platform can help adults living with type 1 diabetes (T1D) in their diabetes self-management. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes, Metabolic Disease, Endocrine System Diseases
- What is being tested?
- Support platform
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 322 participants
- Where
- 4 sitesCanada
- Study dates
- 5 May 2024to Oct 2027
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of T1D (including LADA - latent autoimmune diabetes in adults)
- Have access to Internet
- Use of an active email address
- Comprehension of English or French
- Live in Canada
Who cannot join
- Unable to use the Support platform
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada4 sites, 4 recruiting
- Recruiting
Institut de recherches cliniques de Montréal
Montreal, Quebec, H2W 1R7
Marie Devaux, 5149875500, type1support@mcgill.ca
- Recruiting
Centre hospitalier de l'université de Montreal
Montreal, Quebec, H2X 0C1
Ann Gobeil, 514-890-8000, type1support@mcgill.ca
- Recruiting
Centre hospitalier de Quebec, Université Laval
Québec, Quebec, G1V 0E8
Claudia Huard, 418-525-4444, type1support@mcgill.ca
- Recruiting
Centre de médecine métabolique de Lanaudière
Terrebonne, Quebec, J6x 4P7
Tammy Cadieux, 514-907-5101, type1support@mcgill.ca
About this study
Official title: Using the Support Online Platform for Self-management Education of Adults Living With Type 1 Diabetes as Part of Usual Care or Independently: an Implementation Study
The investigators will conduct a trial to evaluate if an online training and support platform can help adults living with type 1 diabetes (T1D) in their diabetes self-management. Investigators will compare a group that has access to the "Support" platform through their usual medical care to a group that accesses the platform independently. The first group will be recruited through four participating clinics in the province of Quebec (Canada). The second group will be composed of adults living with T1D across Canada. Participants will have access to the platform for 12 months and will be asked to complete online questionnaires at the beginning and after 6 and 12 months, and share their glucose reader data with the research team. A subgroup of participants as well as healthcare professionals from the four clinics will be invited to participate in an individual interview aiming to understand the barriers and facilitators of integration "Support" in clinical care.
Read the detailed description
Type 1 diabetes (T1D) is a chronic condition which requires life-sustaining insulin therapy as well as knowledge, skills and confidence to self-manage. Tailored diabetes self-management education (DSME) should be offered to all people living with diabetes (PWT1D) at diagnosis, but also in a timely manner according to needs. DSME has the potential to improve quality of life and decrease diabetes complications. Despite the positive outcomes of other DSME programs, participation rates of DSME vary greatly perhaps because access remains sub-optimal. Also, healthcare professionals (HCPs) face a challenge to remain aware of the particularities of T1D and stay up-to-date on the rapidly evolving evidence-based knowledge, technologies and therapies available. The investigators propose to examine an online training and peer support platform, called "Support" as a potential alternative for DSME.
The overall purpose of this hybrid effectiveness-implementation study is to investigate if integrating the "Support" platform to routine medical care of adults living with T1D (i.e., diabetes team referring to the "Support" platform during appointments) can improve diabetes self- management, in comparison with navigating the "Support" platform independently of usual care (i.e., the platform not being discussed during appointment) (Effectiveness), and to study the factors affecting its implementation in real-life settings (Implementation).
This study is a mixed-method multi-site, 2 arms, non-randomized, type 1 hybrid effectiveness-implementation trial.
ARM 1: PWT1D participants will have access to Support as part of their regular care (their HCPs will use "Support" in their care). PWT1D participants in ARM 1 are followed in one of the 4 participating clinics either in-person or remotely or hybrid.
ARM 2: PWT1D participants will have access to "Support", independently from their regular care (they may initiate discussion about the platform with their diabetes care team who might register themselves on the platform, but will not prompt to any specific section on the platform and will not receive any training about the platform). PWT1D participants in ARM 2 can be followed in any other clinics in Canada.
Implementation data will be gathered through HCP participants in the participating clinics.
Participants will have to answer online surveys at baseline, 6 months and 12 months. After completing the baseline questionnaire, they will receive an access to the platform. A subgroup of participants as well as participating HCPs will be invited for individual interviews to discuss their experience in using the platform.
- Conditions
- Type 1 Diabetes, Metabolic Disease, Endocrine System Diseases, Autoimmune Diseases, Immune System Diseases
- Being tested
- Support platform
- Keywords
- self-management education, Hemaglobin A1c, Online education, adults, type 1 diabetes
- Medical subject headings
- Diabetes Mellitus, Type 1, Metabolic Diseases, Endocrine System Diseases, Autoimmune Diseases, Immune System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Support platformBehavioural
The study will be conducted over a 12-month period. This should allow participants to see their medical team 2 to 3 times during this timeframe. Participants of arms 1 and 2 will have access to the Support platform and will receive a monthly newsletter, informing them of news on the platform and acting as a reminder to log in. Several features are included in this responsive-designed platform to enhance participation, such as a visual of personal progress, ability to bookmark content, change their avatar.
Support contains 3 main components: Educational material, News blog written by HCPs weekly in collaboration with patient-partners on up-to-date topics related to T1D, a peer-to-peer discussion forum which is moderated daily by a HCP specializing in T1D.
| Study group | Role | What they receive |
|---|---|---|
| Support integrated in usual care | Experimental | PWT1D participants will have access to Support as part of their regular care (their HCPs will use Support in their care). PWT1D participants in ARM 1 are followed in one of the 4 participating clinics either in-person or remotely or hybrid. Receives: Behavioral: Support platform |
| Support through independent access | Active comparator | PWT1D participants will have access to Support, independently from their regular care (they may initiate discussion about the platform with their diabetes care team who might register themselves on the platform, but will not prompt to any specific section on the platform and will not receive any training about the platform). PWT1D participants in ARM 2 can be followed in any other clinics in Canada. Receives: Behavioral: Support platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-efficacy for diabetes management
Diabetes Self-Management Questionnaire-Revised (DSMQ-R; 27-items, score on 10)
Measured: 0, 6 and 12 months
Secondary outcomes (13)
Well-being
WHO-5 well-being index
Measured: 0, 6 and 12 months
Continuous Glucose Monitoring (CGM) - % Time in range
% Time in range (3.9-10.0mmol/L) over the past 4 weeks. Participants may share their account access so the research team will be able to export data or may upload a PDF of their data through REDCap.
Measured: 0, 6 and 12 months
Continuous Glucose Monitoring (CGM) - % Time above range
% Time above range (3.9-10.0mmol/L) over the past 4 weeks. Participants may share their account access so the research team will be able to export data or may upload a PDF of their data through REDCap.
Measured: 0, 6 and 12 months
Continuous Glucose Monitoring (CGM) - % Time below range
% Time below range (3.9-10.0mmol/L) over the past 4 weeks. Participants may share their account access so the research team will be able to export data or may upload a PDF of their data through REDCap.
Measured: 0, 6 and 12 months
Continuous Glucose Monitoring (CGM) - Standard deviation
Standard deviation of the past 4 weeks. Participants may share their account access so the research team will be able to export data or may upload a PDF of their data through REDCap.
Measured: 0, 6 and 12 months
Continuous Glucose Monitoring (CGM) - % Coefficient of variation
% Coefficient of variation of the past 4 weeks. Participants may share their account access so the research team will be able to export data or may upload a PDF of their data through REDCap.
Measured: 0, 6 and 12 months
Hemoglobin A1c
self-reported last Hemoglobin A1c (date and value) through online questionnaire
Measured: 0, 6 and 12 months
Severe hypoglycemic events
Self-reported severe hypoglycemic events in the past 6 months
Measured: 0, 6 and 12 months
Diabetic Ketoacidosis (DKA) events
Self-reported DKA events in the past 6 months
Measured: 0, 6 and 12 months
calls to 911
Self-reported number of calls to 911 in the past 6 months
Measured: 0, 6 and 12 months
calls to 811
Self-reported number of calls to 811 in the past 6 months
Measured: 0, 6 and 12 months
Cost effectiveness (self-efficacy)
Cost effectiveness of access to Support as part of usual care compared with independent access in terms of incremental cost effectiveness ratio (ICER) for self-efficacy
Measured: 6 and 12 months
Cost effectiveness (HbA1c)
Cost effectiveness of access to Support as part of usual care compared with independent access in terms of incremental cost effectiveness ratio (ICER) for HbA1c
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start5 May 2024
- Primary completion5 May 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- mixed-method multi-site, 2 arms, non-randomized, type 1 hybrid effectiveness-implementation trial
- Masking
- None (open label)
- Enrolment
- 322 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Collaborators
- Institut de Recherches Cliniques de Montreal, Centre de Recheche du Centre Hospitalier Université Laval, Centre hospitalier de l'Université de Montréal (CHUM), Centre de médecine métabolique de Lanaudière
- Responsible party
- Principal investigator, Anne-Sophie Brazeau, McGill University
- Investigators
- Anne-Sophie Brazeau, PhD, Principal investigator, School of human nutrition - McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06069583
- Sponsor's protocol ID
- MP-02-2024-11714
- Status last verified
- Sep 2025
- First submitted
- 29 Sep 2023
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Xie LF, Roy-Fleming A, Haag S, Costa DD, Brazeau AS. Development of the Support self-guided, web application for adults living with type 1 diabetes in Canada by a multi-disciplinary team using a people-oriented approach based on the Behaviour Change Wheel. Digit Health. 2023 Jan 24;9:20552076231152760. doi: 10.1177/20552076231152760. eCollection 2023 Jan-Dec.
PubMed 36762025Xie LF, Itzkovitz A, Roy-Fleming A, Da Costa D, Brazeau AS. Understanding Self-Guided Web-Based Educational Interventions for Patients With Chronic Health Conditions: Systematic Review of Intervention Features and Adherence. J Med Internet Res. 2020 Aug 13;22(8):e18355. doi: 10.2196/18355.
PubMed 32788152Kruger J, Brennan A, Thokala P, Basarir H, Jacques R, Elliott J, Heller S, Speight J. The cost-effectiveness of the Dose Adjustment for Normal Eating (DAFNE) structured education programme: an update using the Sheffield Type 1 Diabetes Policy Model. Diabet Med. 2013 Oct;30(10):1236-44. doi: 10.1111/dme.12270. Epub 2013 Aug 19.
PubMed 23815547Stanton-Fay SH, Hamilton K, Chadwick PM, Lorencatto F, Gianfrancesco C, de Zoysa N, Coates E, Cooke D, McBain H, Heller SR, Michie S; DAFNEplus study group. The DAFNEplus programme for sustained type 1 diabetes self management: Intervention development using the Behaviour Change Wheel. Diabet Med. 2021 May;38(5):e14548. doi: 10.1111/dme.14548. Epub 2021 Mar 10.
PubMed 33617669Pereira K, Phillips B, Johnson C, Vorderstrasse A. Internet delivered diabetes self-management education: a review. Diabetes Technol Ther. 2015 Jan;17(1):55-63. doi: 10.1089/dia.2014.0155.
PubMed 25238257Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812.
PubMed 22310560Schmitt A, Kulzer B, Ehrmann D, Haak T, Hermanns N. A Self-Report Measure of Diabetes Self-Management for Type 1 and Type 2 Diabetes: The Diabetes Self-Management Questionnaire-Revised (DSMQ-R) - Clinimetric Evidence From Five Studies. Front Clin Diabetes Healthc. 2022 Jan 13;2:823046. doi: 10.3389/fcdhc.2021.823046. eCollection 2021.
PubMed 36994332
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using the Support Online Platform for Self-management Education of Adults Living With Type 1 Diabetes as Part of Usual Care or Independently: an Implementation Study
- ClinicalTrials.gov ID
- NCT06069583
- Acronym / sponsor ID
- MP-02-2024-11714
- Conditions
- Type 1 Diabetes, Metabolic Disease, Endocrine System Diseases, Autoimmune Diseases, Immune System Diseases
- Keywords
- self-management education, Hemaglobin A1c, Online education, adults, type 1 diabetes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 322 participants (estimated)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Collaborators
- Institut de Recherches Cliniques de Montreal, Centre de Recheche du Centre Hospitalier Université Laval, Centre hospitalier de l'Université de Montréal (CHUM), Centre de médecine métabolique de Lanaudière
- Study start
- 5 May 2024 (actual)
- Primary completion
- 5 May 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 6 Oct 2023 (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.
The investigators will conduct a trial to evaluate if an online training and support platform can help adults living with type 1 diabetes (T1D) in their diabetes self-management. Investigators will compare a group that has access to the "Support" platform through their usual medical care to a group that accesses the platform independently. The first group will be recruited through four participating clinics in the province of Quebec (Canada). The second group will be composed of adults living with T1D across Canada. Participants will have access to the platform for 12 months and will be asked to complete online questionnaires at the beginning and after 6 and 12 months, and share their glucose reader data with the research team. A subgroup of participants as well as healthcare professionals from the four clinics will be invited to participate in an individual interview aiming to understand the barriers and facilitators of integration "Support" in clinical care.
Detailed description
Type 1 diabetes (T1D) is a chronic condition which requires life-sustaining insulin therapy as well as knowledge, skills and confidence to self-manage. Tailored diabetes self-management education (DSME) should be offered to all people living with diabetes (PWT1D) at diagnosis, but also in a timely manner according to needs. DSME has the potential to improve quality of life and decrease diabetes complications. Despite the positive outcomes of other DSME programs, participation rates of DSME vary greatly perhaps because access remains sub-optimal. Also, healthcare professionals (HCPs) face a challenge to remain aware of the particularities of T1D and stay up-to-date on the rapidly evolving evidence-based knowledge, technologies and therapies available. The investigators propose to examine an online training and peer support platform, called "Support" as a potential alternative for DSME.
The overall purpose of this hybrid effectiveness-implementation study is to investigate if integrating the "Support" platform to routine medical care of adults living with T1D (i.e., diabetes team referring to the "Support" platform during appointments) can improve diabetes self- management, in comparison with navigating the "Support" platform independently of usual care (i.e., the platform not being discussed during appointment) (Effectiveness), and to study the factors affecting its implementation in real-life settings (Implementation).
This study is a mixed-method multi-site, 2 arms, non-randomized, type 1 hybrid effectiveness-implementation trial.
ARM 1: PWT1D participants will have access to Support as part of their regular care (their HCPs will use "Support" in their care). PWT1D participants in ARM 1 are followed in one of the 4 participating clinics either in-person or remotely or hybrid.
ARM 2: PWT1D participants will have access to "Support", independently from their regular care (they may initiate discussion about the platform with their diabetes care team who might register themselves on the platform, but will not prompt to any specific section on the platform and will not receive any training about the platform). PWT1D participants in ARM 2 can be followed in any other clinics in Canada.
Implementation data will be gathered through HCP participants in the participating clinics.
Participants will have to answer online surveys at baseline, 6 months and 12 months. After completing the baseline questionnaire, they will receive an access to the platform. A subgroup of participants as well as participating HCPs will be invited for individual interviews to discuss their experience in using the platform.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- mixed-method multi-site, 2 arms, non-randomized, type 1 hybrid effectiveness-implementation trial
| Arm | Type | Receives |
|---|---|---|
| Support integrated in usual care | Experimental | Behavioral: Support platformPWT1D participants will have access to Support as part of their regular care (their HCPs will use Support in their care). PWT1D participants in ARM 1 are followed in one of the 4 participating clinics either in-person or remotely or hybrid. |
| Support through independent access | Active comparator | Behavioral: Support platformPWT1D participants will have access to Support, independently from their regular care (they may initiate discussion about the platform with their diabetes care team who might register themselves on the platform, but will not prompt to any specific section on the platform and will not receive any training about the platform). PWT1D participants in ARM 2 can be followed in any other clinics in Canada. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of T1D (including LADA - latent autoimmune diabetes in adults)
- Have access to Internet
- Use of an active email address
- Comprehension of English or French
- Live in Canada
Key exclusion criteria (1 listed)
- Unable to use the Support platform
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 |
|---|---|---|
| Support platformThe study will be conducted over a 12-month period. This should allow participants to see their medical team 2 to 3 times during this timeframe. Participants of arms 1 and 2 will have access to the Support platform and will receive a monthly newsletter, informing them of news on the platform and acting as a reminder to log in. Several features are included in this responsive-designed platform to enhance participation, such as a visual of personal progress, ability to bookmark content, change their avatar. Support contains 3 main components: Educational material, News blog written by HCPs weekly in collaboration with patient-partners on up-to-date topics related to T1D, a peer-to-peer discussion forum which is moderated daily by a HCP specializing in T1D. | Behavioural | Support integrated in usual care, Support through independent access |
Primary outcome
Self-efficacy for diabetes management
Time frame: 0, 6 and 12 months
Diabetes Self-Management Questionnaire-Revised (DSMQ-R; 27-items, score on 10)
13 secondary outcomes
Well-being
Time frame: 0, 6 and 12 months
Continuous Glucose Monitoring (CGM) - % Time in range
Time frame: 0, 6 and 12 months
Continuous Glucose Monitoring (CGM) - % Time above range
Time frame: 0, 6 and 12 months
Continuous Glucose Monitoring (CGM) - % Time below range
Time frame: 0, 6 and 12 months
Continuous Glucose Monitoring (CGM) - Standard deviation
Time frame: 0, 6 and 12 months
Continuous Glucose Monitoring (CGM) - % Coefficient of variation
Time frame: 0, 6 and 12 months
Hemoglobin A1c
Time frame: 0, 6 and 12 months
Severe hypoglycemic events
Time frame: 0, 6 and 12 months
Diabetic Ketoacidosis (DKA) events
Time frame: 0, 6 and 12 months
calls to 911
Time frame: 0, 6 and 12 months
calls to 811
Time frame: 0, 6 and 12 months
Cost effectiveness (self-efficacy)
Time frame: 6 and 12 months
Cost effectiveness (HbA1c)
Time frame: 6 and 12 months
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 Sep 2025.
- Background: PubMed 36762025Xie LF, Roy-Fleming A, Haag S, Costa DD, Brazeau AS. Development of the Support self-guided, web application for adults living with type 1 diabetes in Canada by a multi-disciplinary team using a people-oriented approach based on the Behaviour Change Wheel. Digit Health. 2023 Jan 24;9:20552076231152760. doi: 10.1177/20552076231152760. eCollection 2023 Jan-Dec.
- Background: PubMed 32788152Xie LF, Itzkovitz A, Roy-Fleming A, Da Costa D, Brazeau AS. Understanding Self-Guided Web-Based Educational Interventions for Patients With Chronic Health Conditions: Systematic Review of Intervention Features and Adherence. J Med Internet Res. 2020 Aug 13;22(8):e18355. doi: 10.2196/18355.
- Background: PubMed 23815547Kruger J, Brennan A, Thokala P, Basarir H, Jacques R, Elliott J, Heller S, Speight J. The cost-effectiveness of the Dose Adjustment for Normal Eating (DAFNE) structured education programme: an update using the Sheffield Type 1 Diabetes Policy Model. Diabet Med. 2013 Oct;30(10):1236-44. doi: 10.1111/dme.12270. Epub 2013 Aug 19.
- Background: PubMed 33617669Stanton-Fay SH, Hamilton K, Chadwick PM, Lorencatto F, Gianfrancesco C, de Zoysa N, Coates E, Cooke D, McBain H, Heller SR, Michie S; DAFNEplus study group. The DAFNEplus programme for sustained type 1 diabetes self management: Intervention development using the Behaviour Change Wheel. Diabet Med. 2021 May;38(5):e14548. doi: 10.1111/dme.14548. Epub 2021 Mar 10.
- Background: PubMed 25238257Pereira K, Phillips B, Johnson C, Vorderstrasse A. Internet delivered diabetes self-management education: a review. Diabetes Technol Ther. 2015 Jan;17(1):55-63. doi: 10.1089/dia.2014.0155.
- Background: PubMed 22310560Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812.
- Background: PubMed 36994332Schmitt A, Kulzer B, Ehrmann D, Haak T, Hermanns N. A Self-Report Measure of Diabetes Self-Management for Type 1 and Type 2 Diabetes: The Diabetes Self-Management Questionnaire-Revised (DSMQ-R) - Clinimetric Evidence From Five Studies. Front Clin Diabetes Healthc. 2022 Jan 13;2:823046. doi: 10.3389/fcdhc.2021.823046. eCollection 2021.
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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.
Anne-Sophie Brazeau, PhD principal investigator
School of human nutrition - McGill University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Support platform in people with Type 1 Diabetes and Metabolic Disease, run by McGill University at 4 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 5 inclusion and 1 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 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 Anne-Sophie Brazeau, PhD (5143987848, anne-sophie.brazeau@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-efficacy for diabetes management (time frame: 0, 6 and 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 NCT06069583, which also lists 7 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 Sep 2025.