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Insul-In This Together Program for Type 1 Diabetes (IITT Trial)
N/A
Waitlist Available
Led By Korey K Hood, PhD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up average percent time in range based on two weeks of glucose monitoring data at 6-month follow-up (plus or minus 2 weeks around target data collection date)
Awards & highlights
IITT Trial Summary
This trial is testing a family intervention for teens with type 1 diabetes and their parents to see if it can help manage the risks of the disease.
Who is the study for?
This trial is for teens aged 12-19 with Type 1 Diabetes, diagnosed for at least 6 months. They must have a parent willing to participate and both should be able to use a smartphone or Wi-Fi-enabled computer. Teens with developmental, cognitive, or psychiatric conditions affecting study participation are excluded.Check my eligibility
What is being tested?
The 'Insul-In This Together' program is being tested to see if it helps teenagers with Type 1 Diabetes and their parents manage the psychosocial challenges and self-care requirements of diabetes more effectively.See study design
What are the potential side effects?
Since this intervention focuses on family-based education and support rather than medication, there may not be direct medical side effects; however, participants might experience emotional discomfort during discussions.
IITT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ average percent time in range based on two weeks of glucose monitoring data at 6-month follow-up (plus or minus 2 weeks around target data collection date)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~average percent time in range based on two weeks of glucose monitoring data at 6-month follow-up (plus or minus 2 weeks around target data collection date)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adolescent quality of life
Glucose levels percent time in target range based on glucose monitoring
Secondary outcome measures
Adolescent depression
Adolescent distress
Hemoglobin A1c (HbA1c)
+3 moreIITT Trial Design
2Treatment groups
Experimental Treatment
Group I: Waitlisted Control GroupExperimental Treatment1 Intervention
The waitlisted control group will receive the same intervention as the intervention group, but at the 6-month follow-up mark. The intervention will be conducted by the PI or clinically trained research staff via Zoom. Online surveys, and glucose monitoring data will be captured at baseline and 3,6 and 12-month follow-ups. Brief surveys will also be conducted at 2-, 4-, and 6-week from baseline. Participants will be asked to provide A1C test results that will be collected via chart review or from participants sharing their test results at baseline, 6-month, and 12-month follow-up.
Group II: Intervention GroupExperimental Treatment1 Intervention
The intervention group will participated in the The Insul-In This Together intervention, which consists of 6 weekly 30-minute online family sessions to discuss topics related to diabetes distress and parent-teen communication. Sessions include structured education, discussions, and skill-building activities related to parental involvement, parental monitoring, and parent-adolescent conflict. The intervention will be conducted by the PI or clinically trained research staff via Zoom. Online surveys, and glucose monitoring data will be captured at baseline and 3,6 and 12-month follow-ups. Brief surveys will also be conducted at 2-, 4-, and 6-week follow-ups (after every 2 sessions for the intervention group and later the control group). Participants will be asked to provide A1C test results that will be collected via chart review or from participants sharing their test results at baseline, 6-month, and 12-month follow-up.
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Who is running the clinical trial?
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,357 Previous Clinical Trials
4,314,872 Total Patients Enrolled
Stanford UniversityLead Sponsor
2,387 Previous Clinical Trials
17,333,736 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,696 Previous Clinical Trials
6,952,265 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a teenager diagnosed with type 1 diabetes for at least 6 months.I am a teenager aged 12-19.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention Group
- Group 2: Waitlisted Control Group
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.
Are there any remaining openings to become part of this experimental research?
"This clinical trial is presently recruiting participants, as stated on the clinicaltrials.gov website. The study was released to the public on December 18th 2020 and underwent its most recent refreshment on May 4th 2022."
Answered by AI
How many participants have been admitted to this clinical experiment?
"Affirmative. Evidence found on clinicaltrials.gov attests to the fact that this medical trial, inaugurated on December 18th 2020, is currently recruiting new participants. The initiative requires 330 individuals at a single site of study."
Answered by AI
What key goals are investigators attempting to accomplish through this clinical research?
"The main goal of this clinical trial, evaluated over a 6-month period, is to assess the impact on glucose levels. Additionally, researchers are studying parent diabetes distress (as measured via PAID survey), adolescent distress (also assessed through PAID questionnaire) and parenting stress (utilizing the Parenting Stress Scale)."
Answered by AI
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