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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
Must not have
Diabetes diagnosis other than T1D
Individuals > 21 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3, 6, 9 and 12 months
Awards & highlights
No Placebo-Only Group

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.
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.
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
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with a type of diabetes that is not Type 1.
Select...
I am older than 21 years.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in rise of HbA1c
Secondary study objectives
Change Diabetes Distress Scale
Change in CGM Benefits and Burden Scale
Change in Diabetes Technology Attitude Scale
+8 more
Other study objectives
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
2,840 Previous Clinical Trials
8,172,120 Total Patients Enrolled
Stanford UniversityLead Sponsor
2,491 Previous Clinical Trials
17,518,712 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,464 Previous Clinical Trials
4,336,953 Total Patients Enrolled
David M Maahs, MD, PhDPrincipal InvestigatorLucile Packard Children's Hospital; Stanford University, School of Medicine
3 Previous Clinical Trials
5,100 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
~42 spots leftby May 2025
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