← Back to Search

Behavioural Intervention

Digital Health Management Tool for Type 1 Diabetes (KiT Trial)

N/A
Recruiting
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
Proficient in written and spoken English or French
Possession of their own personal mobile device that can support SMS with sufficient capacity to send and receive SMS/texts
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

KiT Trial Summary

This trial is testing whether a digital tool can help young adults with type 1 diabetes feel more confident in managing their disease.

Who is the study for?
This trial is for young adults with Type 1 Diabetes who are transitioning to adult care. They must be within 6 months of turning 18 or transferring care, willing to complete questionnaires, and proficient in English or French. Participants need a mobile device capable of SMS and an email address. Those with intellectual disabilities affecting diabetes care or enrolled in other SMS-based trials can't join.Check my eligibility
What is being tested?
The study tests an eHealth tool designed to help improve self-care in managing Type 1 Diabetes during the transition from pediatric to adult healthcare services. The effectiveness will be measured through questionnaires at baseline, six months, and twelve months after starting the use of the digital tool.See study design
What are the potential side effects?
Since this trial involves an eHealth digital tool rather than medication, traditional side effects are not expected. However, participants may experience issues related to technology use such as eye strain or stress due to constant health monitoring.

KiT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am proficient in English or French.
Select...
I own a mobile device capable of sending and receiving texts.
Select...
I am getting outpatient care for Type 1 Diabetes at a center involved in this study.
Select...
I have been diagnosed with type 1 diabetes.

KiT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To test the effect of a text message-based T1D transition intervention compared to control at 12 months in the Self-Efficacy for Diabetes management scale. A higher score indicates better self-efficacy.
Secondary outcome measures
Compare text message-based T1D transition intervention to control at 6 months in the Self-Efficacy for Diabetes management scale. Higher score indicates better self efficacy.
Evaluate the impact of this text message-based intervention compared to usual care at 12 months on self-reported Barriers to Diabetes Adherence in Adolescence questionnaire (BDA) Stigma subscale
Evaluate the impact of this text message-based intervention compared to usual care at 12 months using self-reported A1c values
+17 more
Other outcome measures
Evaluation of intervention fidelity
Evaluation of participant engagement with the intervention looking at which types of messages are the most and least engaged with
Evaluation of participant engagement with the intervention with number of participants who are engaging with intervention messages

KiT Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: eHealth ToolExperimental Treatment1 Intervention
The Intervention is a text messaging algorithm that will operate like a chatbot, querying adolescents with T1D about their confidence with different aspects of T1D self-management as they are preparing to transition to adult diabetes care. The intervention has 4 components of messaging: personalized Educational Content, Standard Educational Curriculum, Provide participant compensation for filling out the questionnaires, Question & Answer feature.
Group II: ControlActive Control1 Intervention
Participants randomized to the control arm will also be offered the same incentives to complete questionnaires (outcome measures) but will not receive any other components of the intervention - no personalized/customized support or diabetes resource messages and no reminders. Control arm participants will continue with their usual T1D transition care.

Find a Location

Who is running the clinical trial?

Trillium Health PartnersOTHER
7 Previous Clinical Trials
2,855 Total Patients Enrolled
University Health Network, TorontoOTHER
1,475 Previous Clinical Trials
484,907 Total Patients Enrolled
The Hospital for Sick ChildrenLead Sponsor
690 Previous Clinical Trials
6,945,295 Total Patients Enrolled

Media Library

eHealth Tool (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05434754 — N/A
Type 1 Diabetes Research Study Groups: Control, eHealth Tool
Type 1 Diabetes Clinical Trial 2023: eHealth Tool Highlights & Side Effects. Trial Name: NCT05434754 — N/A
eHealth Tool (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05434754 — N/A

Frequently Asked Questions

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

Are there any age restrictions for participation in this medical trial?

"The parameters for eligibility in this trial are narrow, spanning from 17 to 19 years of age. However, there is a larger selection of studies available for people younger than 18 and older than 65 with 216 and 920 trials respectively."

Answered by AI

Who has the requisite qualifications to partake in this research trial?

"This trial seeks to recruit 267 adolescents between the ages of 17 and 19 who have type 1 diabetes. To qualify, they must possess a valid mobile phone number, email address, own a smartphone capable of sending/receiving SMS messages, be proficient in English or French language skills and have their medical chart indicate they are suffering from T1D. They will also need to consent to participate within 3-4 months after either planned transfer or turning 18 years old. Furthermore, participants should agree to complete study outcome measures (questionnaires) at all study time-points regardless of which arm they are randomized into: baseline, 6 months and 12"

Answered by AI

In what locations is the research experiment being conducted?

"Currently, 6 different medical centres are offering this trial: McGill University Health Centre in Montréal, Oak Valley Health in Markham, The Hospital for Sick Children in Toronto, and 3 other sites."

Answered by AI

Is enrollment in this research project still available to the public?

"Clinicaltrials.gov does not indicate that this study is currently recruiting, as it was last updated on October 25th 2022 following its initial posting on December 1st of the same year. However, there are a plethora of alternative clinical trials looking for volunteers at present, totaling 1253 opportunities."

Answered by AI

Who else is applying?

What state do they live in?
Ohio
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Keeping in Touch (KiT) With Youth as They Transition to Adult Type 1 Diabetes Care
Rayzel Shulman 2022. "Keeping in Touch (KiT) With Youth as They Transition to Adult Type 1 Diabetes Care". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05434754.
All > Type 1 Diabetes
~7 spots leftby Jun 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top