Type 1 Diabetes (T1D)TECC-T1D3NCT06804694
Technology-Enabled Collaborative Care for Young Adults With Type 1 Diabetes and Diabetes Distress: A Feasibility Trial
A study testing TECC-T1D3 Program and Education Intervention in people with Type 1 Diabetes (T1D) and Diabetes Distress, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
The goal of the study is to evaluate the acceptability and feasibility of a co-designed, Technology-Enabled Collaborative Care for Young Adults with Type-1 Diabetes and Diabetes Distress (TECC-T1D3) program. Read more about this study
- Who is it for?
- Ages 18 to 29 years
- Conditions the study is for
- Type 1 Diabetes (T1D), Diabetes Distress
- What is being tested?
- TECC-T1D3 Program and Education Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 27 Nov 2024to Sep 2025
- 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 to 29 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Young adult (age 18-29 years)
- Resident of Ontario
- Living with a self-reported diagnosis of T1D of at least 1 year
- Individual is community-living (people who live independently in the community and are not residing in a setting that provide institutional care or support)
Who cannot join
- Unable to participate in English language
- Unable to participate via telephone or web-conferencing
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
Centre for Addiction and Mental Health
Toronto, Ontario, M6J 1H4
Anika Research Coordinator, 4165358501 ext. 37407, anika.saiva@camh.ca
Peter Selby
About this study
Official title: Technology-Enabled Collaborative Care for Young Adults With Type-1 Diabetes and Diabetes Distress (TECCT1D3): Feasibility Trial of a Co-designed Intervention
The goal of the study is to evaluate the acceptability and feasibility of a co-designed, Technology-Enabled Collaborative Care for Young Adults with Type-1 Diabetes and Diabetes Distress (TECC-T1D3) program. Through this program, the investigators aim to deliver a collaborative care intervention, featuring a health coach and a virtual care team, designed to help participants manage mental health and overall wellbeing.
Read the detailed description
A total of 60 young adults with Type 1 Diabetes (T1D) will be enrolled in the study. Participants will be randomly allocated to either a coaching intervention or an education intervention for 12 weeks. During the 12-week program, participants in the coaching intervention will take part in 8-10 sessions with a health coach, where experiences living with diabetes and goals related to diabetes management, communication with a support system, and overall wellbeing will be discussed. Participants in the education intervention will receive generalized educational messages about diabetes and diabetes distress exclusively via automated emails. Before and after the program, participants will complete surveys to provide an understanding of how diabetes and diabetes-related distress are being managed. After completing the respective interventions, participants will have a one-on-one interview with the research team to discuss their experience with the program and potential areas for improvement.
The goal of the program is to enhance the quality of life for young adults with T1D who experience significant emotional burdens associated with the condition. The study addresses a critical research gap by integrating mental health support with diabetes management, a need historically underserved in healthcare settings. By developing a structured mental health intervention that is accessible and scalable, the study addresses the need for a model of whole-person care that incorporates psychological aspects as part of standard diabetes management. The model of care and findings could potentially be applied to other chronic conditions, broadening the impact of the study beyond diabetes to other areas of chronic disease management.
- Conditions
- Type 1 Diabetes (T1D), Diabetes Distress
- Being tested
- TECC-T1D3 Program, Education Intervention
- Keywords
- Type 1 Diabetes, TECC model, Diabetes Distress, Technology-enabled Care, Young adults with T1D
- 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.
TECC-T1D3 ProgramBehavioural
The TECC-T1D3 program is a twelve-week virtual care intervention designed to support individuals with Type 1 Diabetes (T1D) and Diabetes Distress. The program includes a health coach (HC) and a virtual care team (VCT) of T1D, mental health experts and peer support, offering comprehensive care through various communication channels, including WebEx, phone calls, and text messaging. The program aims to: i. Provide T1D specific mental health and wellbeing support, ii. Provide guidance on how to communicate with others about T1D, manage stigma and ask for help with diabetes management and iii. Facilitate connections with T1D communities. Participants can choose topics of discussion based on their needs and will be directly supported by the HC and indirectly monitored by VCT.
Education InterventionOther
The Education Intervention is a low-intensity, education-focused intervention consisting of 10 automated emails over 12 weeks, providing generalized educational messages with links to resources for mental health support and well-being for individuals living with T1D.
| Study group | Role | What they receive |
|---|---|---|
| Coaching Intervention (TECC-T1D3 Program) | Experimental | Participants will complete a 12-weeks, virtual, TECC-T1D3 program, delivered through an omnichannel, patient-centered approach, which may include WebEx, phone calls, or text messaging. The participants will complete weekly coaching sessions with the health coach and is indirectly supported by a virtual care team comprised of mental health and T1D experts as well as peer support. Receives: Behavioral: TECC-T1D3 Program |
| Education Intervention | Active comparator | Participants will receive a low-intensity, education-focused intervention consisting of 10 automated emails over 12 weeks, providing generalized educational messages with links to resources for mental health support and well-being for individuals living with T1D. Receives: Other: Education Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility - Recruitment Rate (Both Arms)
The primary outcome in this study is feasibility specifically focusing on process outcomes. This includes assessing recruitment number.
Measured: Through the study completion, an average of 6 months
Feasibility - Engagement Rate (Both Arms)
The primary outcome in this study is feasibility, specifically focusing on process outcomes. This includes percentage of consented participants who proceed to randomization.
Measured: From consent to randomization throughout the study (average of 6 months)
Feasibility - Completion of Study Assessments (Both Arms)
Coaching Intervention: Participants attending a minimum of 8 sessions out of a possible maximum of 10 sessions Education Intervention: Participants opening a minimum of 8 emails out of the 10 emails
Measured: Up to 12-weeks
Acceptability - Qualitative (Both Arms)
Participants' perceptions, experiences, and satisfaction with the intervention assessed through post-intervention interviews. Interviews will explore perceived impact on health, motivation, and suggestions for improvement.
Measured: Within two weeks post-intervention, after completing the 12-weeks program
Delivery of the Digital Intervention - Number of Sessions Completed (Coaching Intervention only)
- The number of sessions completed.
Measured: Up to 12-weeks
Delivery of the Digital Intervention - Mode of Interaction (Coaching Intervention only)
Measurement include:
- Number of interaction categorized by the mode of delivery (web-conference, telephone or text message).
Measured: Up to 12-weeks
Delivery of Digital Intervention - Time Spent per Session (Coaching Intervention only)
- Average time spent by health coach per interaction/session with participants in minutes.
Measured: Up to 12-weeks
Secondary outcomes (6)
Quality of Life (Both Arms)
the European Quality of Life - 5 Dimensions, 5 Levels (EQ-5D-5L) scale: This measure will assess overall well-being and satisfaction with life among participants. The scale evaluates five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with five levels of severity.
Unit of Measure: EQ-5D-5L index score. Minimum Value: 0 (the worst possible health state). Maximum Value: 100 (the best possible health state). Interpretation: Higher scores indicate better health-related quality of life.
Measured: Baseline (Week 1) and Post-Intervention (Week 12)
Self-efficacy (Both Arms)
Diabetes Empowerment Scale - Short Form (DES-SF) Scale:
This measure will evaluate participants' beliefs in their ability to effectively manage their diabetes and related challenges.
Minimum Value: 1 (low self-efficacy). Maximum Value: 5 (high self-efficacy). Interpretation: Higher scores indicate greater self-efficacy in managing diabetes.
Measured: Baseline (Week 1) and Post-Intervention (Week 12)
Diabetes Distress (Both Arms)
Type 1 Diabetes Distress Assessment (T1DDAS) Scale: This scale evaluates ten distinct sources of diabetes-related distress. Each source is scored individually by averaging the responses to relevant items.
Sources: Financial Worries, Interpersonal Challenges, Management Difficulties, Shame, Hypoglycemia Concerns, Healthcare Quality, Lack of Diabetes Resources, Technology Challenges, Burden to Others, Worries About Complications.
Minimum Value: 1 (no distress). Maximum Value: 5 (highest distress). Interpretation: Higher scores indicate a greater impact of the source on diabetes distress.
Measured: Baseline (Week 1) and Post-Intervention (Week 12)
Diabetes Distress (Both Arms)
Problem Areas in Diabetes Scale (PAID-5) Score: This will measure the level of emotional distress and burden associated with living with Type 1 Diabetes.
Minimum Value: 0 (no distress). Maximum Value: 20 (high distress). Interpretation: Higher scores indicate greater levels of emotional distress related to diabetes.
Measured: Baseline (Week 1) and Post-Intervention (Week 12)
Self-reported HbA1C Levels (Both Arms)
This measure assesses blood sugar control over the past 2-3 months. Participants can choose to self-report and collection of this data will be optional.
Measured: Baseline (Week 1) and Post-Intervention (Week 12)
Connectedness to Care (Both Arms)
This measure will assess participants' perceptions of their connection to their diabetes care and peer support using a series of 5-point Likert scale questions regarding their care and support experiences.
Scale Values:
- = Strongly Agree
- = Agree
- = Neither Agree nor Disagree
- = Disagree
- = Strongly Disagree
Minimum Value: 1 (strongest sense of connectedness). Maximum Value: 5 (lowest sense of connectedness).
Interpretation: Lower average scores indicate a stronger sense of belonging and engagement with the T1D community.
Measured: Baseline (Week 1) and Post-Intervention (Week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start27 Nov 2024
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes (T1D)Studies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- Brain Canada, Juvenile Diabetes Research Foundation
- Responsible party
- Principal investigator, Peter Selby, Centre for Addiction and Mental Health
- Investigators
- Peter Selby, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06804694
- Sponsor's protocol ID
- 2024/065
- Acronym
- TECC-T1D3
- Status last verified
- Jan 2025
- First submitted
- 6 Jan 2025
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Whitmore C, Mangialardi N, Saiva A, Cafazzo JA, McQuire T, Mytkolli L, St John A, Senior P, Sherifali D, Strudwick G, Selby P. Evaluating the feasibility of a co-designed technology-enabled, collaborative care program for young adults with type 1 diabetes and diabetes distress: A protocol. Digit Health. 2025 Jul 29;11:20552076251365134. doi: 10.1177/20552076251365134. eCollection 2025 Jan-Dec.
PubMed 40755960
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology-Enabled Collaborative Care for Young Adults With Type-1 Diabetes and Diabetes Distress (TECCT1D3): Feasibility Trial of a Co-designed Intervention
- ClinicalTrials.gov ID
- NCT06804694
- Acronym / sponsor ID
- TECC-T1D3 / 2024/065
- Conditions
- Type 1 Diabetes (T1D), Diabetes Distress
- Keywords
- Type 1 Diabetes, TECC model, Diabetes Distress, Technology-enabled Care, Young adults with T1D
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- Brain Canada, Juvenile Diabetes Research Foundation
- Study start
- 27 Nov 2024 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 3 Feb 2025 (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 goal of the study is to evaluate the acceptability and feasibility of a co-designed, Technology-Enabled Collaborative Care for Young Adults with Type-1 Diabetes and Diabetes Distress (TECC-T1D3) program. Through this program, the investigators aim to deliver a collaborative care intervention, featuring a health coach and a virtual care team, designed to help participants manage mental health and overall wellbeing.
Detailed description
A total of 60 young adults with Type 1 Diabetes (T1D) will be enrolled in the study. Participants will be randomly allocated to either a coaching intervention or an education intervention for 12 weeks. During the 12-week program, participants in the coaching intervention will take part in 8-10 sessions with a health coach, where experiences living with diabetes and goals related to diabetes management, communication with a support system, and overall wellbeing will be discussed. Participants in the education intervention will receive generalized educational messages about diabetes and diabetes distress exclusively via automated emails. Before and after the program, participants will complete surveys to provide an understanding of how diabetes and diabetes-related distress are being managed. After completing the respective interventions, participants will have a one-on-one interview with the research team to discuss their experience with the program and potential areas for improvement.
The goal of the program is to enhance the quality of life for young adults with T1D who experience significant emotional burdens associated with the condition. The study addresses a critical research gap by integrating mental health support with diabetes management, a need historically underserved in healthcare settings. By developing a structured mental health intervention that is accessible and scalable, the study addresses the need for a model of whole-person care that incorporates psychological aspects as part of standard diabetes management. The model of care and findings could potentially be applied to other chronic conditions, broadening the impact of the study beyond diabetes to other areas of chronic disease management.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coaching Intervention (TECC-T1D3 Program) | Experimental | Behavioral: TECC-T1D3 ProgramParticipants will complete a 12-weeks, virtual, TECC-T1D3 program, delivered through an omnichannel, patient-centered approach, which may include WebEx, phone calls, or text messaging. The participants will complete weekly coaching sessions with the health coach and is indirectly supported by a virtual care team comprised of mental health and T1D experts as well as peer support. |
| Education Intervention | Active comparator | Other: Education InterventionParticipants will receive a low-intensity, education-focused intervention consisting of 10 automated emails over 12 weeks, providing generalized educational messages with links to resources for mental health support and well-being for individuals living with T1D. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Young adult (age 18-29 years)
- Resident of Ontario
- Living with a self-reported diagnosis of T1D of at least 1 year
- Individual is community-living (people who live independently in the community and are not residing in a setting that provide institutional care or support)
Key exclusion criteria (2 listed)
- Unable to participate in English language
- Unable to participate via telephone or web-conferencing
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 |
|---|---|---|
| TECC-T1D3 ProgramThe TECC-T1D3 program is a twelve-week virtual care intervention designed to support individuals with Type 1 Diabetes (T1D) and Diabetes Distress. The program includes a health coach (HC) and a virtual care team (VCT) of T1D, mental health experts and peer support, offering comprehensive care through various communication channels, including WebEx, phone calls, and text messaging. The program aims to: i. Provide T1D specific mental health and wellbeing support, ii. Provide guidance on how to communicate with others about T1D, manage stigma and ask for help with diabetes management and iii. Facilitate connections with T1D communities. Participants can choose topics of discussion based on their needs and will be directly supported by the HC and indirectly monitored by VCT. | Behavioural | Coaching Intervention (TECC-T1D3 Program) |
| Education InterventionThe Education Intervention is a low-intensity, education-focused intervention consisting of 10 automated emails over 12 weeks, providing generalized educational messages with links to resources for mental health support and well-being for individuals living with T1D. | Other | Education Intervention |
Primary outcome
Feasibility - Recruitment Rate (Both Arms)
Time frame: Through the study completion, an average of 6 months
The primary outcome in this study is feasibility specifically focusing on process outcomes. This includes assessing recruitment number.
Feasibility - Engagement Rate (Both Arms)
Time frame: From consent to randomization throughout the study (average of 6 months)
The primary outcome in this study is feasibility, specifically focusing on process outcomes. This includes percentage of consented participants who proceed to randomization.
Feasibility - Completion of Study Assessments (Both Arms)
Time frame: Up to 12-weeks
Coaching Intervention: Participants attending a minimum of 8 sessions out of a possible maximum of 10 sessions Education Intervention: Participants opening a minimum of 8 emails out of the 10 emails
Acceptability - Qualitative (Both Arms)
Time frame: Within two weeks post-intervention, after completing the 12-weeks program
Participants' perceptions, experiences, and satisfaction with the intervention assessed through post-intervention interviews. Interviews will explore perceived impact on health, motivation, and suggestions for improvement.
Delivery of the Digital Intervention - Number of Sessions Completed (Coaching Intervention only)
Time frame: Up to 12-weeks
• The number of sessions completed.
Delivery of the Digital Intervention - Mode of Interaction (Coaching Intervention only)
Time frame: Up to 12-weeks
Measurement include: • Number of interaction categorized by the mode of delivery (web-conference, telephone or text message).
Delivery of Digital Intervention - Time Spent per Session (Coaching Intervention only)
Time frame: Up to 12-weeks
• Average time spent by health coach per interaction/session with participants in minutes.
6 secondary outcomes
Quality of Life (Both Arms)
Time frame: Baseline (Week 1) and Post-Intervention (Week 12)
Self-efficacy (Both Arms)
Time frame: Baseline (Week 1) and Post-Intervention (Week 12)
Diabetes Distress (Both Arms)
Time frame: Baseline (Week 1) and Post-Intervention (Week 12)
Diabetes Distress (Both Arms)
Time frame: Baseline (Week 1) and Post-Intervention (Week 12)
Self-reported HbA1C Levels (Both Arms)
Time frame: Baseline (Week 1) and Post-Intervention (Week 12)
Connectedness to Care (Both Arms)
Time frame: Baseline (Week 1) and Post-Intervention (Week 12)
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 3 Feb 2025.
- Derived from this study: PubMed 40755960Whitmore C, Mangialardi N, Saiva A, Cafazzo JA, McQuire T, Mytkolli L, St John A, Senior P, Sherifali D, Strudwick G, Selby P. Evaluating the feasibility of a co-designed technology-enabled, collaborative care program for young adults with type 1 diabetes and diabetes distress: A protocol. Digit Health. 2025 Jul 29;11:20552076251365134. doi: 10.1177/20552076251365134. eCollection 2025 Jan-Dec.
- 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.
Peter Selby principal investigator
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TECC-T1D3 Program and Education Intervention in people with Type 1 Diabetes (T1D) and Diabetes Distress, run by Centre for Addiction and Mental Health 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?
The sponsor lists 4 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 3 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 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 Anika Saiva, MPH ((416) 535-8501 ext. 37407, anika.saiva@camh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility - Recruitment Rate (Both Arms) (time frame: Through the study completion, an average of 6 months). The study lists 7 primary outcomes in all. 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 NCT06804694, which also lists 1 linked publication.
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 3 Feb 2025.