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Support-t Online Training for Type 1 Diabetes Transition Care (Support-t Trial)
N/A
Recruiting
Led By Anne-Sophie Brazeau, PhD
Research Sponsored by Anne-Sophie Brazeau
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6, 12, 18 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will study how an online training and peer support platform can help teens with Type 1 Diabetes transition to adult care.
Who is the study for?
This trial is for 14-16 year olds with Type 1 Diabetes who are patients at one of four specific pediatric diabetes clinics in Quebec. They must have internet access, an active email, and speak English or French. It's not specified who can't join.
What is being tested?
The study tests 'Support-t', an online training and peer support platform designed to help youths with Type 1 Diabetes as they prepare to move from child to adult care services. The effect on blood sugar control, health outcomes, and mental well-being will be compared with usual care.
What are the potential side effects?
Since 'Support-t' is a non-medical intervention focusing on education and social support, it does not have typical medical side effects. However, participants may experience stress or anxiety related to the use of technology or the transition process.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6, 12, 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6, 12, 18 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from Baseline Hemaglobin A1c (HbA1c) at 18 months
Secondary study objectives
Change from Baseline Hemaglobin A1c (HbA1c) at 6 and 12 months
Continuous Glucose Monitoring (CGM) - % Coefficient of variation
Continuous Glucose Monitoring (CGM) - % Time above range
+15 moreOther study objectives
Engagement with Support-t platform (Health Care Provider) - content accessed
Engagement with Support-t platform (Health Care Provider) - downloaded documents
Engagement with Support-t platform (Health Care Provider) - time in minutes on platform
+11 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Support-t plus usual diabetes careExperimental Treatment1 Intervention
Access to the Support-t online training and peer support platform in addition to usual diabetes care for 18 months. Support-t contains 3 components: 1) Educational material, 2) News blog and 3) Patients' discussion forum. Health care providers from the pediatric diabetes clinics will receive Support-t training and will be encouraged to recommend the Support-t platform during routine care with their patients from the active arm.
Group II: Usual diabetes care onlyActive Control1 Intervention
Usual diabetes care for 18 months, which consists of visits with their health care provider and ad-hoc diabetes education with nurses and dietitians. Health care providers from the pediatric diabetes clinics will be instructed not to discuss or refer to the Support-t platform with patients from the control arm. Control arm participants will have the option to use the Support-t platform after the 18-month study.
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Who is running the clinical trial?
CHU de Quebec-Universite LavalOTHER
171 Previous Clinical Trials
109,405 Total Patients Enrolled
Anne-Sophie BrazeauLead Sponsor
McGill UniversityLead Sponsor
410 Previous Clinical Trials
1,018,272 Total Patients Enrolled
2 Trials studying Diabetes
95 Patients Enrolled for Diabetes
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a teenager diagnosed with Type 1 Diabetes.I have a condition like hemolytic anemia that affects my red blood cell lifespan.I am between 14 and 16 years old.I have an active email address.I am fluent in English or French.
Research Study Groups:
This trial has the following groups:- Group 1: Support-t plus usual diabetes care
- Group 2: Usual diabetes care only
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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