Status:
ACTIVE_NOT_RECRUITING
Teamwork, Targets, Technology, and Tight Control in Newly Diagnosed Pediatric T1D - 4T Study
Lead Sponsor:
Stanford University
Collaborating Sponsors:
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Type1diabetes
Eligibility:
All Genders
6-21 years
Phase:
NA
Brief Summary
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.
Detailed Description
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 (T...
Eligibility Criteria
Inclusion
- (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 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
- 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
Key Trial Info
Start Date :
June 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2026
Estimated Enrollment :
316 Patients enrolled
Trial Details
Trial ID
NCT04336969
Start Date
June 18 2020
End Date
December 30 2026
Last Update
July 4 2025
Active Locations (1)
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1
Franziska Katherine Bishop
Steamboat Springs, Colorado, United States, 80487