Teamwork, Targets, Technology, and Tight Control in Newly Diagnosed Pediatric T1D

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

316 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-18

Study Completion Date

2026-12-30

Brief Summary

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The 4T program encompasses: Teamwork, Targets, Technology, and Tight Range. These methods will help patients better manage their condition of Type 1 Diabetes with improved patient-reported outcomes.

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Detailed Description

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The goal of the 4T study is to implement proven methods and emerging diabetes technology into the investigator's clinical practice to sustain a tight glucose range from the onset of type 1 diabetes (T1D) and optimize patient-reported and psychosocial outcomes. The investigators will define a program (4T - Teamwork, Targets, Technology, and Tight Range) translatable to Pediatric Diabetes clinics in the United States that reduces HbA1c and T1D burden and improves patient well-being.

Study Design: This is a prospective, open-label, pragmatic research study. Two related studies will be performed. In Study 2, a cohort of new onsets (183) receiving the 4T new onset intervention designed to decrease the rise in HbA1c seen from 4 to 12 months but following a tapered (from weekly to monthly) remote monitoring schedule will be compared to internal (4T Pilot and 4T Study 1) and external contemporaneous controls (CMH and DPV).

Conditions

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Type1diabetes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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T1D Patients

Participants will wear a Continuous Glucose Monitor (CGM) with remote data monitoring

Group Type OTHER

4T Education and Care

Intervention Type BEHAVIORAL

CGM data will be used to create customized weekly or monthly feedback to the participant/family by secure MyChart message.

Interventions

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4T Education and Care

CGM data will be used to create customized weekly or monthly feedback to the participant/family by secure MyChart message.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* All individuals within one month of T1D diagnosis seen at the Stanford Children's Diabetes Clinic
* Individuals who plan to receive follow up care at the Stanford Children's Diabetes Clinic
* Individuals who agree to CGM data integration into the EMR for remote monitoring
* Age: six months to \< 21 years of age
* Patient or guardian must own and operate an Apple compatible device (e.g., iPhone or iPod Touch) to allow for the Dexcom app and CGM data transmission to the hospital server-based remote monitoring system.

Dr Prahalad's LPCH Auxiliary Fund grant (in addition to the R18) has resources to support iPod Touch/iPhone purchases for participants who do not have these.

o For the Exercise Ancillary study: 11 to \< 21 years of age (the activity tracker is not validated for younger children) English and Spanish-Speaking (Study 2)

Exclusion Criteria

* Diabetes diagnosis other than T1D
* Diagnosis of diabetes \> one month prior to initial visit
* Individuals with the intention of obtaining diabetes care at another clinic
* Individuals who do not consent to CGM use, CGM data integration, remote monitoring
* Individuals \> 21 years of age

Minimum Eligible Age

6 Months

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No