Teamwork, Targets, Technology, and Tight Control in Newly Diagnosed Pediatric T1D - 4T Study

Trial ID or NCT#

NCT04336969

Status

not recruiting iconNOT RECRUITING

Purpose

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

Official Title

Teamwork, Targets, Technology, and Tight Control in Newly Diagnosed Pediatric T1D - 4T Study

Eligibility Criteria

Ages Eligible for Study: 6 Months to 21 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. (Inclusion criteria includes all youth with new onset T1D seen in the Stanford/Lucile Packard Children's Hospital ages 6 months-21 years of age. We intend to include all possible patients with the goal of maximizing generalizability of the results and 4T program. (NOTE: We will include children and families who speak all languages using the Stanford interpreter services so as to have the greatest generalizability of the research. Questionnaires will only be given to English and Spanish speakers.)
    1. * 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 Dexcom app and Apple HealthKit integration and transmission to the hospital server-based remote monitoring system and EHR.
      1. Dr Prahalad's LPCH Auxiliary Fund grant (in addition to the R18) has resources to support iPod Touch purchase for participants who do not have these.
        1. 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:
  1. * 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
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Investigator(s)

David Maahs
Dessi Zaharieva

View on ClinicalTrials.gov