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Technology-Education Intervention for Type 1 Diabetes (ROUTE-T1D Trial)
N/A
Waitlist Available
Led By Randi Streisand, PhD
Research Sponsored by Children's National Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosed with type 1 diabetes for at least 6 months
10-15 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 month post randomization
Awards & highlights
ROUTE-T1D Trial Summary
This trial will test a behavioral intervention to help young adolescents with type 1 diabetes better control their blood sugar levels using a continuous glucose monitor.
Who is the study for?
This trial is for young adolescents aged 10-15 with type 1 diabetes for at least 6 months, who are starting or restarting a continuous glucose monitor (CGM) after not using it for a year. It's not suitable for those under 10 or over 15, currently using CGM, diagnosed less than 6 months ago, or with major conditions like cancer.Check my eligibility
What is being tested?
The study tests a behavioral intervention aimed to help these adolescents use CGM effectively. The focus is on optimizing technology usage through diabetes education and parent coaching support, especially targeting groups often left out of such research.See study design
What are the potential side effects?
Since the interventions involve education and coaching rather than medication, traditional side effects are not expected. However, participants may experience stress or discomfort related to changes in their routine due to the intervention.
ROUTE-T1D Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with type 1 diabetes for over 6 months.
Select...
I am between 10 and 15 years old.
ROUTE-T1D Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 month post randomization
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 month post randomization
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Glycemic control
glycemic variability
Secondary outcome measures
CGM benefits and burdens
CGM use
Diabetes Distress
+2 moreROUTE-T1D Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Immediate interventionExperimental Treatment1 Intervention
Participants randomized to the immediate intervention group will participate in 3 video-conferencing sessions with a Certified Diabetes Care and Education Specialist (CDCES) interventionist and connect with a peer parent consultant immediately post randomization (expected intervention duration: 3 months).
Group II: Wait-list/delayed interventionActive Control1 Intervention
Participants randomized to the delayed intervention group will receive no intervention for 6 months post-randomization; after the 6-month follow-up period, the delayed intervention group also will participate in 3 video conferencing sessions with a CDCES interventionist and connect with a peer parent consultant (expected intervention duration: 3 months).
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Who is running the clinical trial?
Children's National Research InstituteLead Sponsor
210 Previous Clinical Trials
207,697 Total Patients Enrolled
Randi Streisand, PhDPrincipal InvestigatorChildren's National Hosptial
1 Previous Clinical Trials
52 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been using a continuous glucose monitor recently.I have been diagnosed with type 1 diabetes for over 6 months.I am starting or restarting a continuous glucose monitor after a year.I am between 10 and 15 years old.I am either under 10 or over 15 years old.I have a major medical condition like another cancer or cystic fibrosis.I was diagnosed with type 1 diabetes less than 6 months ago.
Research Study Groups:
This trial has the following groups:- Group 1: Wait-list/delayed intervention
- Group 2: Immediate 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.
Is there an age limit for enrolment in this trial?
"In agreement with the trial's regulations, the age range for potential participants is 10-15 years of age."
Answered by AI
What key goals are this study attempting to accomplish?
"The main outcome to be examined over a 12-month post randomisation period is an assessment of glycaemic control. Additional metrics, such as Family Conflict (measured using the Diabetes Family Conflict Scale-Revised with scores ranging 19-57), CGM Benefits and Burdens (utilising The BenCGM and BurCGM) and Diabetes Distress (Problem Areas in Diabetes scales [PAID] scored 14-84) will also be considered."
Answered by AI
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