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Teamwork, Targets, Technology, and Tight Control in Newly Diagnosed Pediatric T1D - 4T Study
Recruiting
Trial ID: NCT04336969
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
Stanford Investigator(s)
Eligibility
Inclusion Criteria: (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.)
- 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.
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.
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
Intervention(s):
behavioral: 4T Education and Care
Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305