Type 1 Diabetes (T1D)NCT07317986
CommuniT1D: A Customized Virtual Peer Support Program For People Living With Type 1 Diabetes In Canada
A study testing Peer support meetings in people with Type 1 Diabetes (T1D), run by Laval University at 1 site in Canada.
Trial summary
When you live with type 1 diabetes (T1D), it is easy to feel alone. Managing your own T1D or your child's T1D takes constant effort that is invisible to most people. Often, the only people who really understand what you are going through are other people in similar situations, but it's hard to find those people… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes (T1D)
- What is being tested?
- Peer support meetings
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteCanada
- Study dates
- 7 Jul 2025to Jul 2029
- 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
- Healthy volunteers accepted
- Adult, Older adult
Inclusion Criteria: Participants in CommuniT1D must be people living with T1D or another rare, insulin-requiring form of diabetes, namely, Latent autoimmune diabetes of adults (LADA), Maturity-Onset Diabetes of the Youth (MODY), or type 3c, which occurs due to an injury to or removal of the pancreas. Loved ones such as a parent, child, spouse, caregiver, or friend of an individual with T1D or other rarer forms of diabetes will also be eligible to participate in CommuniT1D. Participants must be 18 years and older, reside in Canada, and be able to read the consent form in English or French.
Exclusion Criteria: Individuals with type 2 diabetes, pre-diabetes, or gestational diabetes and no connection to T1D, LADA, MODY, type 3c, or other rare, insulin-requiring forms of diabetes will not be included in CommuniT1D. Individuals under 18 years old will also be ineligible to participate. As the program grows, we hope to expand to also include adolescents and children, who may need parental consent for them to join, depending on their Canadian province or territory of residence. Should we be able to pursue this option, we will work with institutional research ethics boards to ensure that we welcome participation by youth while also ensuring their safety within CommuniT1D. In such a case, the age restrictions in our eligibility criteria would change.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Université Laval
Québec, Quebec, G1V 0A6
Holly Witteman, PhD, 418-656-2131, holly.witteman@fmed.ulaval.ca
About this study
When you live with type 1 diabetes (T1D), it is easy to feel alone. Managing your own T1D or your child's T1D takes constant effort that is invisible to most people. Often, the only people who really understand what you are going through are other people in similar situations, but it's hard to find those people, especially when there are other aspects of your life that might be different from others with T1D. For example, you might have a very young child with T1D, you might be racialized and deal with racism in health care on top of T1D, you might be going through menopause with T1D, you might be aging out of provincial or parental device coverage, you might speak a different language from most people around you with T1D, or any one of many other things that make your situation unique. This project aims to create regular, small online meetings via Zoom or similar technologies to bring together people across Canada who are managing T1D (their own and/or their child's) who have other things in common. We will create these small groups that will meet monthly as well as larger monthly webinars covering topics of interest. We will track how people like the groups, how they feel, what they like and don't like, and adjust the program accordingly. This project is led by researchers and others who themselves live with T1D. We believe that this kind of peer support can be extremely helpful to people with T1D and it will provide needed mental health support.
Read the detailed description
Background and objectives: Type 1 diabetes (T1D) is a largely self-managed condition that requires ongoing daily tasks and decisions. Many people living with T1D in Canada manage it alone, which can feel very isolating and negatively affect physical and mental health. Connecting with other people in similar situations may help to reduce the potential burden associated with managing this health condition. We aim to co-develop and evaluate a virtual peer support program called CommuniT1D, led by people with T1D, to improve the overall wellbeing of people across Canada whose lives are affected by T1D.
Methods and analysis: Using a community-based participatory design and action research approach and a realist evaluation framework, we will first co-develop CommuniT1D by working together as a group of people with T1D, researchers, and clinicians. Over two thirds of steering committee members live with T1D (their own or their child's.) This collective lived expertise is complemented by experts in mental health, social support, health services research, and other relevant fields. Once the program is ready to welcome members, we will work with our partner organizations, networks, and use tailored ads to recruit CommuniT1D peer leaders and members. We will then form virtual peer support groups of people with shared lived experience. Within the program, we will hold monthly small group meetings led by peer leaders via an online platform. We will also hold monthly large webinars open to all CommuniT1D members and other interested people. To evaluate CommuniT1D, we will conduct surveys at baseline and every 6 months, collecting data about diabetes distress, life challenges, quality of life, wellbeing, management indicators, and access and use of management tools and services. We will analyze quantitative data using repeated measures analysis of variance. We will also conduct individual interviews with CommuniT1D members and peer leaders at two time points. We will analyze interview data thematically, and create a logic model by triangulating results from qualitative and quantitative analyses, applying a realist evaluation lens.
Discussion: Peer support may help people with T1D feel less alone and better supported. This protocol outlines the design of a virtual peer support program called CommuniT1D to improve the wellbeing of people whose lives are affected by T1D in Canada. We hope that this program will help better equip people with T1D to cope with T1D-related stressors, thus improving the lives of people with T1D in Canada.
- Conditions
- Type 1 Diabetes (T1D)
- Being tested
- Peer support meetings
- Keywords
- peer support
- 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.
Peer support meetingsOther
Online videoconference meetings held approximately monthly.
| Study group | Role | What they receive |
|---|---|---|
| CommuniT1D arm | Experimental | People in the intervention will be offered a peer support intervention consisting of monthly Zoom meetings with peers in similar situations. Receives: Other: Peer support meetings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetes Distress
We will use the Type 1 Diabetes Distress Scale [PMID: 25765489] and work with our steering committee to adapt the scale in order to address specific life situations relevant to our participants. For example, for CommuniT1D members who are employed, we will add two additional questions about work-related diabetes distress. [PMID: 29604390] For parents of teens with T1D, we will use the Parent Diabetes Distress Scale (PARENT-DSS) [https://behavioraldiabetes.org/scales-and-measures/#1448434808823-e055c4f8-b047] and will adapt this scale for parents of younger children with T1D. For partners of individuals with T1D, we will use the Partner Diabetes Distress Scale (PARTNER-DDS). [https://behavioraldiabetes.org/scales-and-measures/#1448434936830-83758e0b-2ee4] Lower diabetes distress scores are considered desirable compared to higher scores.
Measured: Every 6 months from enrollment to the end of intervention (estimated 2 years)
Secondary outcomes (8)
Caregiver Stress
For participants who identify as caregivers of a person living with T1D, we will use the Kingston Caregiver Stress Scale. [http://www. kingstonscales.org/caregiver-stress-scale.htm]
Measured: Every 6 months from enrollment to the end of intervention (estimated 2 years)
Anxiety and Depression
We will measure symptoms of anxiety and depression using the Hospital Anxiety and Depression Scale (HADS). [PMID: 6880820]
Measured: Every 6 months from enrollment to the end of intervention (estimated 2 years)
Self-Efficacy
We will evaluate diabetes-specific self-efficacy using the Confidence in Diabetes Scale, which measures participants' confidence in their ability to perform essential diabetes self-care activities. [PMID: 12610027]
Measured: Every 6 months from enrollment to the end of intervention (estimated 2 years)
Fear of Hypoglycemia
To examine fear of hypoglycemia, we will use the short form of the Hypoglycemia Fear Survey II, a validated tool that captures behavioral and emotional responses related to hypoglycemic episodes. [PMID: 27278467]
Measured: Every 6 months from enrollment to the end of intervention (estimated 2 years)
Well-Being
We will assess general psychological well-being with the WHO-5 Well-Being Index. This brief instrument has demonstrated high sensitivity for detecting depressive symptoms and is validated in populations with T1D. [PMID: 17475940]
Measured: Every 6 months from enrollment to the end of intervention (estimated 2 years)
Diabetes-Specific Quality of Life
We will measure diabetes-specific quality of life using the Audit of Diabetes-Dependent Quality of Life (ADDQoL). [PMID: 10457741]
Measured: Every 6 months from enrollment to the end of intervention (estimated 2 years)
Perceived Social Support
To capture perceived social support, we will use a 5-item adaptation of the Social Provisions Scale developed specifically for Canadian populations. [https://doi.org/10.24095/hpcdp.39.12.02]
Measured: Every 6 months from enrollment to the end of intervention (estimated 2 years)
Self-Compassion
We will measure self-compassion using the Self-Compassion Scale-Short Form (SCS-SF). [https://doi.org/10.1080/15298860309027]
Measured: Every 6 months from enrollment to the end of intervention (estimated 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start7 Jul 2025
- Primary completionJul 2028 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes (T1D)Studies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07317986
- Sponsor's protocol ID
- CommuniT1D
- Status last verified
- Sep 2025
- First submitted
- 19 Dec 2025
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized data will be shared on Borealis (Université Laval's Dataverse instance.)
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CommuniT1D: A Customized Virtual Peer Support Program For People Living With Type 1 Diabetes In Canada
- ClinicalTrials.gov ID
- NCT07317986
- Acronym / sponsor ID
- CommuniT1D
- Conditions
- Type 1 Diabetes (T1D)
- Keywords
- peer support
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- 7 Jul 2025 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 5 Jan 2026 (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.
When you live with type 1 diabetes (T1D), it is easy to feel alone. Managing your own T1D or your child's T1D takes constant effort that is invisible to most people. Often, the only people who really understand what you are going through are other people in similar situations, but it's hard to find those people, especially when there are other aspects of your life that might be different from others with T1D. For example, you might have a very young child with T1D, you might be racialized and deal with racism in health care on top of T1D, you might be going through menopause with T1D, you might be aging out of provincial or parental device coverage, you might speak a different language from most people around you with T1D, or any one of many other things that make your situation unique. This project aims to create regular, small online meetings via Zoom or similar technologies to bring together people across Canada who are managing T1D (their own and/or their child's) who have other things in common. We will create these small groups that will meet monthly as well as larger monthly webinars covering topics of interest. We will track how people like the groups, how they feel, what they like and don't like, and adjust the program accordingly. This project is led by researchers and others who themselves live with T1D. We believe that this kind of peer support can be extremely helpful to people with T1D and it will provide needed mental health support.
Detailed description
Background and objectives: Type 1 diabetes (T1D) is a largely self-managed condition that requires ongoing daily tasks and decisions. Many people living with T1D in Canada manage it alone, which can feel very isolating and negatively affect physical and mental health. Connecting with other people in similar situations may help to reduce the potential burden associated with managing this health condition. We aim to co-develop and evaluate a virtual peer support program called CommuniT1D, led by people with T1D, to improve the overall wellbeing of people across Canada whose lives are affected by T1D.
Methods and analysis: Using a community-based participatory design and action research approach and a realist evaluation framework, we will first co-develop CommuniT1D by working together as a group of people with T1D, researchers, and clinicians. Over two thirds of steering committee members live with T1D (their own or their child's.) This collective lived expertise is complemented by experts in mental health, social support, health services research, and other relevant fields. Once the program is ready to welcome members, we will work with our partner organizations, networks, and use tailored ads to recruit CommuniT1D peer leaders and members. We will then form virtual peer support groups of people with shared lived experience. Within the program, we will hold monthly small group meetings led by peer leaders via an online platform. We will also hold monthly large webinars open to all CommuniT1D members and other interested people. To evaluate CommuniT1D, we will conduct surveys at baseline and every 6 months, collecting data about diabetes distress, life challenges, quality of life, wellbeing, management indicators, and access and use of management tools and services. We will analyze quantitative data using repeated measures analysis of variance. We will also conduct individual interviews with CommuniT1D members and peer leaders at two time points. We will analyze interview data thematically, and create a logic model by triangulating results from qualitative and quantitative analyses, applying a realist evaluation lens.
Discussion: Peer support may help people with T1D feel less alone and better supported. This protocol outlines the design of a virtual peer support program called CommuniT1D to improve the wellbeing of people whose lives are affected by T1D in Canada. We hope that this program will help better equip people with T1D to cope with T1D-related stressors, thus improving the lives of people with T1D in Canada.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CommuniT1D arm | Experimental | Other: Peer support meetingsPeople in the intervention will be offered a peer support intervention consisting of monthly Zoom meetings with peers in similar situations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Peer support meetingsOnline videoconference meetings held approximately monthly. | Other | CommuniT1D arm |
Primary outcome
Diabetes Distress
Time frame: Every 6 months from enrollment to the end of intervention (estimated 2 years)
We will use the Type 1 Diabetes Distress Scale [PMID: 25765489] and work with our steering committee to adapt the scale in order to address specific life situations relevant to our participants. For example, for CommuniT1D members who are employed, we will add two additional questions about work-related diabetes distress. [PMID: 29604390] For parents of teens with T1D, we will use the Parent Diabetes Distress Scale (PARENT-DSS) [https://behavioraldiabetes.org/scales-and-measures/#1448434808823-e055c4f8-b047] and will adapt this scale for parents of younger children with T1D. For partners of individuals with T1D, we will use the Partner Diabetes Distress Scale (PARTNER-DDS). [https://behavioraldiabetes.org/scales-and-measures/#1448434936830-83758e0b-2ee4] Lower diabetes distress scores are considered desirable compared to higher scores.
8 secondary outcomes
Caregiver Stress
Time frame: Every 6 months from enrollment to the end of intervention (estimated 2 years)
Anxiety and Depression
Time frame: Every 6 months from enrollment to the end of intervention (estimated 2 years)
Self-Efficacy
Time frame: Every 6 months from enrollment to the end of intervention (estimated 2 years)
Fear of Hypoglycemia
Time frame: Every 6 months from enrollment to the end of intervention (estimated 2 years)
Well-Being
Time frame: Every 6 months from enrollment to the end of intervention (estimated 2 years)
Diabetes-Specific Quality of Life
Time frame: Every 6 months from enrollment to the end of intervention (estimated 2 years)
Perceived Social Support
Time frame: Every 6 months from enrollment to the end of intervention (estimated 2 years)
Self-Compassion
Time frame: Every 6 months from enrollment to the end of intervention (estimated 2 years)
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 5 Jan 2026.
- Individual participant dataSharing planned: Yes. Anonymized data will be shared on Borealis (Université Laval's Dataverse instance.)
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer support meetings in people with Type 1 Diabetes (T1D), run by Laval University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Holly Witteman, PhD (418-656-2131, holly.witteman@fmed.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diabetes Distress (time frame: Every 6 months from enrollment to the end of intervention (estimated 2 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jan 2026.