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Recruiting NCT06804694

Technology-Enabled Collaborative Care for Young Adults With Type 1 Diabetes and Diabetes Distress: A Feasibility Trial

No phase Interventional Type 1 Diabetes (T1D) Diabetes Distress

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TECC-T1D3 Program, Education Intervention.
Who it may be relevant to
Registry conditions: Type 1 Diabetes (T1D), Diabetes Distress. Basic parameters: 18 years — 29 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Technology-Enabled Collaborative Care for Young Adults With Type-1 Diabetes and Diabetes Distress (TECCT1D3): Feasibility Trial of a Co-designed Intervention

Overview

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.

Interventions

  • Behavioral TECC-T1D3 Program
    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 com
  • Other Education Intervention
    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.

Primary outcome measures

  • Feasibility - Recruitment Rate (Both Arms) [Time frame: Through the study completion, an average of 6 months]
  • Feasibility - Engagement Rate (Both Arms) [Time frame: From consent to randomization throughout the study (average of 6 months)]
  • Feasibility - Completion of Study Assessments (Both Arms) [Time frame: Up to 12-weeks]
  • Acceptability - Qualitative (Both Arms) [Time frame: Within two weeks post-intervention, after completing the 12-weeks program]
  • Delivery of the Digital Intervention - Number of Sessions Completed (Coaching Intervention only) [Time frame: Up to 12-weeks]
  • Delivery of the Digital Intervention - Mode of Interaction (Coaching Intervention only) [Time frame: Up to 12-weeks]
  • Delivery of Digital Intervention - Time Spent per Session (Coaching Intervention only) [Time frame: Up to 12-weeks]
Secondary outcome measures (6)
  • 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)]

Eligibility criteria

Inclusion criteria

  • 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)

Exclusion criteria

  • Unable to participate in English language
  • Unable to participate via telephone or web-conferencing

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

Canada · 1 center
  • Centre for Addiction and Mental Health — Toronto

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. PMID 40755960

Identifiers

NCT: NCT06804694 · 2024/065

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗