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Type 1 Diabetes Virtual Self-management Education and Support

Study acronym: T1ME
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv15
  2. Study sites: 8 to 9v14
  3. Eligibility criteria expanded, about 25 wordsv13 See this version in full on ClinicalTrials.gov ↗
  4. Study sites: 7 to 8v12
  5. Site contacts updated at 1 of 7 sitesv11
Show 9 earlier versionsHide 9 earlier versions
  1. Study sites revised (7)v10 See this version in full on ClinicalTrials.gov ↗
  2. Site details revised at 1 of 7 sitesv9
  3. Study sites: 5 to 7v8
  4. Study sites: 4 to 5v7
  5. Primary completion date: Dec 31, 2024 to Dec 31, 2026 Study sites: 3 to 4 · Completion date: Jun 30, 2025 to Mar 31, 2027 · Eligibility criteria revisedv6 Show 3 more changesShow less
    • Study sites: 3 to 4
    • Completion date: Jun 30, 2025 to Mar 31, 2027
    • Eligibility criteria revised

    See this version in full on ClinicalTrials.gov ↗

  6. Study sites: 2 to 3v5
  7. Study sites: 1 to 2v4
  8. Start date changed from estimate of Jun 6, 2023 to May 10, 2023v3
  9. Trial status: Not Yet Recruiting to Recruiting Start date: Apr 3, 2023 to Jun 6, 2023 · Study sites: 0 to 1v2 Show 2 more changesShow less
    • Start date: Apr 3, 2023 to Jun 6, 2023
    • Study sites: 0 to 1
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Unity Health Toronto
85 trials monitored
See 4 trials at risk
Diabetes
4,286 trials monitored
See 187 trials at risk
Type 1 Diabetes
853 trials monitored
See 38 trials at risk
OVERVIEW: People living with type 1 diabetes (T1D) are expected to fit self-management and regular clinical consultations into busy lives. T1D self-management programs that offer frequent contact with care teams are most effective in helping patients achieve optimal glycemic control. However, this is difficult to deliver in the context of current T1D care which involves time-consuming in-person visits during working hours. The proposed study will test a virtual health care intervention to deliver "high frequency, low touch" care aimed at improving metabolic control, while reducing the burden on individuals and their healthcare teams. STUDY DESIGN: A pragmatic multicenter, open-label, randomized trial to evaluate the short-term effectiveness of a multifaceted virtual health care intervention in improving glycemic control in individuals with T1D. Planned recruitment is 580 participants from 10 specialized T1D centres in Ontario. INTERVENTION: Our intervention will include 1) frequent, brief virtual visits between patients with T1D and certified diabetes educators (conducted in real time using a secure telemedicine video interface accessible from any PC, tablet or smart phone) combined with automatic appointment reminders, and 2) a centralized web-based platform to provide educational classes, tools, and resources for diabetes self-management. Virtual visits will be an adjunct to routine in-clinic visits for blood pressure monitoring, foot checks, and surveillance for other complications of diabetes. This approach aims to enable patients to receive more education and support than is feasible in traditional health care models, and in a way that is more seamless (i.e. results in fewer disruptions to their daily life) and tailored to their individual needs based on their stage in life.
Trial Details
NCT Number NCT05756829
Lead Sponsor Unity Health Toronto
Conditions type1diabetes
Enrollment 580 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov