Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-24 @ 10:48 PM
NCT ID:
NCT04336969
Eligibility Criteria:
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 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
21 Years
Study:
NCT04336969
Study Brief:
Protocol Section:
NCT04336969