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Data Platform + Feedback for Type 1 Diabetes
N/A
Waitlist Available
Led By Rayzel Shulman, Md, PhD
Research Sponsored by The Hospital for Sick Children
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time in months up to 12 months after the final pediatric visit
Awards & highlights
Study Summary
This trial is designed to improve care and outcomes for youth with type 1 diabetes as they transition to adult care.
Who is the study for?
This trial is for young people aged approximately 16-19 with type 1 diabetes who are transitioning from pediatric to adult care in Ontario. They must have been followed at participating centers and be capable of reading English and consenting for themselves. Those with non-type 1 diabetes, moving out of Ontario within a year, or unable to consent are excluded.Check my eligibility
What is being tested?
The study tests whether a data platform combined with quality performance feedback reports can improve the transition from pediatric to adult diabetes care. It aims to enhance glycemic control during this changeover period and evaluate the intervention's effectiveness.See study design
What are the potential side effects?
Since this trial involves data management and feedback systems rather than medical treatments, traditional physical side effects are not applicable. However, participants may experience stress or anxiety related to adapting new routines or due to performance feedback.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ hba1c value up to 12 months after the final pediatric visit.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~hba1c value up to 12 months after the final pediatric visit.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
HbA1c
Secondary outcome measures
Number of Diabetes-related admissions, ED visits, death
Time from the final pediatric visit to the first adult diabetes visit
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Post-InterventionExperimental Treatment1 Intervention
Those whose last pediatric visit was in the second year after the intervention (2020).
The intervention includes the following :
Data Platform: Medical record data abstracted from patient charts at the time of the final pediatric visit. .
Quality performance feedback reports: We will generate centre-level performance reports. Centres will be able to compare their performance to that of all other centres and to achievable benchmarks.
Patient transition experience surveys at the final pediatric visit and 12 months later.
Diabetes teams may direct patients and families to online transition resources.
Group II: Early InterventionExperimental Treatment1 Intervention
Those whose last pediatric visit was in the year immediately after the start of the intervention (2019).
The intervention will begin on Jan 1, 2019 and includes the following :
Data Platform: Medical record data abstracted from patient charts at the time of the final pediatric visit. .
Quality performance feedback reports: We will generate centre-level performance reports. Centres will be able to compare their performance to that of all other centres and to achievable benchmarks.
Patient transition experience surveys at the final pediatric visit and 12 months later.
Diabetes teams may direct patients and families to online transition resources.
Group III: Pre-interventionActive Control1 Intervention
Those whose last pediatric visit was in the year before the intervention (2018).
Medical record data abstracted from patient charts at the time of the final pediatric visit.
Find a Location
Who is running the clinical trial?
The Hospital for Sick ChildrenLead Sponsor
686 Previous Clinical Trials
6,944,309 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,341 Previous Clinical Trials
26,452,229 Total Patients Enrolled
Rayzel Shulman, Md, PhDPrincipal InvestigatorThe Hospital for Sick Children
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Participants are between 16 and 19 years old and will be moving to adult healthcare.All children diagnosed with type 1 diabetes and seen at participating centers between January 1, 2018, and December 31, 2020.You have type 1 diabetes and are planning to move out of Ontario within 12 months after your last pediatric visit.People with type 1 diabetes who cannot give their own permission to join the study.You have a type of diabetes that is not type 1.
Research Study Groups:
This trial has the following groups:- Group 1: Pre-intervention
- Group 2: Early Intervention
- Group 3: Post-Intervention
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Where are the sites of this research endeavor?
"This clinical trial is currently recruiting from 5 medical sites, including Children's Hospital in London, the London Health Sciences Centre, Markham Stouffville Hospital, Clinic 4 in Markham and The Hospital for Sick Children located in Toronto. Additionally, there are an additional five locations that have expressed interest."
Answered by AI
Is this investigation open to volunteers of any age?
"The parameters for this clinical trial necessitate that qualified participants be between 16 and 19 years old. An additional 211 trials are available to minors, while 915 studies have been designed with aged patients in mind."
Answered by AI
What are the qualifications for enrolling in this research endeavor?
"Participants must meet the criteria of having type 1 diabetes mellitus and be between 16 to 19 years old in order for their application to qualify. At present, this clinical trial is aiming at recruiting a total of 484 people into its research programme."
Answered by AI
Are new participants still being taken in for this clinical experiment?
"Clinicaltrials.gov's information indicates that this clinical trial is not currently enrolling patients, despite originally being posted on June 1st 2019 and last edited on May 5th 2022. However, 1242 other trials are actively recruiting at the present time."
Answered by AI
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