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Virtual Self-management Education and Support for Type 1 Diabetes (T1ME Trial)

N/A

Recruiting

Led By Gillian Booth, MD

Research Sponsored by Unity Health Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Physician diagnosis of type 1 diabetes

Currently on an insulin pump or using multiple daily insulin injections

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, pre-intervention and up to 4 weeks after the intervention

Awards & highlights

T1ME Trial Summary

This trial tests a virtual health care intervention to improve glycemic control for people with T1D, while reducing burden on individuals and health teams. Recruiting 580 participants from 10 Ontario T1D centres.

Who is the study for?

This trial is for adults over 18 with Type 1 Diabetes who have a high HbA1c level (≥8.0%), use an insulin pump or multiple daily injections, and can handle both in-person and virtual healthcare visits for 6 months. Participants need reliable internet access, an email address, and must be fluent in English. Pregnant individuals, those on dialysis, or unable to use digital devices are excluded.Check my eligibility

What is being tested?

The study tests a 'high frequency, low touch' virtual healthcare program designed to improve diabetes management without disrupting daily life. It includes regular brief online meetings with diabetes educators and a web platform offering educational resources tailored to the patient's life stage.See study design

What are the potential side effects?

Since this intervention focuses on education and support through technology rather than medication or invasive procedures, traditional side effects are not applicable. However, participants may experience technical issues or stress related to adapting to new technologies.

T1ME Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with type 1 diabetes by a doctor.

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I use an insulin pump or take several insulin injections daily.

T1ME Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, pre-intervention and up to 4 weeks after the intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, pre-intervention and up to 4 weeks after the intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, pre-intervention and up to 4 weeks after the intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from Baseline HbA1c at 6 months

T1ME Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: High frequency, low-touch virtual health careExperimental Treatment1 Intervention

Participants in this arm will receive a high frequency, low-touch virtual health care intervention through the Maple application, as an adjunct to usual T1D care. High-frequency visits will occur every 2 +/- 1 weeks for a total of 6 months. Participants will also receive access to a virtual library to support T1D self-learning and as a guided educational tool.

Group II: Standard CareActive Control1 Intervention

Participants in this arm will receive the standard of care offered for their condition and by their clinic.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Unity Health TorontoLead Sponsor

539 Previous Clinical Trials

447,185 Total Patients Enrolled

Gillian Booth, MDPrincipal InvestigatorUnity Health Toronto

Media Library

High frequency, low touch virtual health care Clinical Trial Eligibility Overview. Trial Name: NCT05756829 — N/A

Type 1 Diabetes Research Study Groups: High frequency, low-touch virtual health care, Standard Care

Type 1 Diabetes Clinical Trial 2023: High frequency, low touch virtual health care Highlights & Side Effects. Trial Name: NCT05756829 — N/A

High frequency, low touch virtual health care 2023 Treatment Timeline for Medical Study. Trial Name: NCT05756829 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals have been included in the current research protocol?

"Affirmative. The details on clinicaltrials.gov demonstrate that recruitment for this research is currently ongoing, having been first posted on June 6th 2023 and most recently updated May 8th 2023. This experiment requires 580 participants at a single medical centre to participate."

Answered by AI

Are there still opportunities available for individuals to participate in this experiment?

"Affirmative, the clinicaltrials.gov portal indicates that this investigation is actively seeking enrolment from participants. It was initially registered on June 6th 2023 and revised lastly on May 8th 2023. The research endeavour needs 580 people to be enrolled at 1 facility."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Type 1 Diabetes Virtual Self-management Education and Support

Gillian Booth 2023. "Type 1 Diabetes Virtual Self-management Education and Support". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05756829.