A Pilot Study of Biomarkers of Stress in Youth Who Use Teens.Connect

Completed · Not applicable

Conditions studied: Diabetes Mellitus, Type 1

In brief

This feasibility/pilot study has three purposes. First, the investigators will determine the feasibility of collecting saliva to measure stress biomarkers over three days at home in youth. Second, the investigators will conduct a pilot study of the Teens.Connect Internet program for youth with type 1 diabetes to determine whether changes in stress biomarkers associate with self-reported perceived stress and HbA1c. Third, the investigators will examine the gene-environment interaction of the top 14 targeted candidate genes and epi-genome wide effects of teens' stress biomarkers and its influence on blood glucose levels over time.

Key facts

Study ID

NCT02970656

Run by

Yale University

People needed

29

Starts

2017-02-08

Expected to finish

2019-02-28

Last updated by the study team

2019-04-02

Who can join

Age: 11 and older, up to 14. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• diagnosed with T1D for at least 6 months;
• age 11 to 14 years
• naïve to TEENCOPE and/or Managing Diabetes
• assent and parent/guardian consent to participate in the study

You may not qualify if…

• medical condition that impacts cortisol functioning
• takes medications that impact cortisol, except diabetes medications
• sleeps less than 6 hours per night
• smokes
• takes oral contraceptives

Where it is running

• Yale School of Nursing — West Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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