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4T Education and Care for Type 1 Diabetes

N/A
Waitlist Available
Led By David M Maahs, MD, PhD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
All youth with new onset T1D seen in the Stanford/Lucile Packard Children's Hospital ages 6 months-21 years of age
Age: six months to < 21 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3, 6, 9 and 12 months
Awards & highlights

Study Summary

This trial will help patients with Type 1 Diabetes better manage their condition with improved patient reported outcomes by utilizing the 4Ts program: Teamwork, Targets, Technology, and Tight Control.

Who is the study for?
The trial is for children and young adults under 21 with newly diagnosed Type 1 Diabetes. Participants must have an Apple device to use specific apps for monitoring, agree to continuous glucose monitoring (CGM) data sharing, and plan to receive care at the Stanford Children's Diabetes Clinic.Check my eligibility
What is being tested?
The '4T' program being tested includes Teamwork, Targets, Technology, and Tight Control strategies aimed at improving self-management of Type 1 Diabetes in pediatric patients through education and advanced care techniques.See study design
What are the potential side effects?
Since this trial focuses on education and technology-based diabetes management rather than medication or invasive procedures, traditional side effects are not a concern. However, there may be challenges related to adapting to technology use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 6 months and 21 years old and have been diagnosed with Type 1 Diabetes.
Select...
I am between six months and 21 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3, 6, 9 and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3, 6, 9 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
Change in rise of HbA1c
Secondary outcome measures
Change Diabetes Distress Scale
Change in CGM Benefits and Burden Scale
Change in Diabetes Technology Attitude Scale
+8 more
Other outcome measures
T1D Patients receiving 4T education and care monitored on a step-down cadence in study 2, will achieve an HBA1c non-inferior to weekly review

Trial Design

1Treatment groups
Experimental Treatment
Group I: T1D PatientsExperimental Treatment1 Intervention
Participants will wear a Continuous Glucose Monitor (CGM) with remote data monitoring

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH
2,696 Previous Clinical Trials
6,952,088 Total Patients Enrolled
Stanford UniversityLead Sponsor
2,386 Previous Clinical Trials
17,333,508 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,356 Previous Clinical Trials
4,314,566 Total Patients Enrolled

Media Library

4T Education and Care Clinical Trial Eligibility Overview. Trial Name: NCT04336969 — N/A
Type 1 Diabetes Research Study Groups: T1D Patients
Type 1 Diabetes Clinical Trial 2023: 4T Education and Care Highlights & Side Effects. Trial Name: NCT04336969 — N/A
4T Education and Care 2023 Treatment Timeline for Medical Study. Trial Name: NCT04336969 — N/A

Frequently Asked Questions

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

Who meets the criteria for participating in this research study?

"This clinical trial is recruiting 500 diabetic and autoimmune patients aged 1 to 20. The most noteworthy requirements are an age of six months or older, possession of Apple-compatible devices (e.g., iPhone or iPod Touch) for Dexcom app use and data integration into the EMR for remote monitoring, follow up care at Stanford Children's Diabetes Clinic, as well as access to resources from Dr Prahalad LPCH Auxiliary Fund grant in order to acquire iPods when necessary."

Answered by AI

Can individuals still apply to be a participant in this trial?

"The clinicaltrials.gov data indicates that this research is not actively seeking participants at the moment. Initially posted on June 18th, 2020 and last updated February 10th 2022, the study has since completed recruitment of its candidates. However, there are numerous other trials which may require volunteers; 370 studies in total are currently recruiting subjects for their respective protocols."

Answered by AI

Does the age cutoff for this healthcare research allow those below 45 to participate?

"The requirements for inclusion in this clinical trial dictate that participants must be at least 1 year old and no older than 20."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Teamwork, Targets, Technology, and Tight Control in Newly Diagnosed Pediatric T1D - 4T Study
David Maahs 2020. "Teamwork, Targets, Technology, and Tight Control in Newly Diagnosed Pediatric T1D - 4T Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04336969.
~58 spots leftby Oct 2024
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