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

Intensive management of type 1 diabetes (T1D) among youth as recommended by the American
Diabetes Association requires a complex set of self-management activities that create high
levels of perceived stress in youth and families. In individuals exposed to chronic stress,
such as that of a chronic condition, the body responds with physiological and hormonal
responses to adapt. These responses can be harmful (e.g., higher glucose levels, higher
HbA1c). Such harmful effects may be ameliorated by programs that reduce psychosocial stress.

The investigators have found an Internet-delivered coping skills training program combined
with a diabetes education program significantly improved HbA1c and QOL for youth with T1D.
Self-reported perceived stress mediated these outcomes. There has been little to no
examination, however, of whether a reduction in self-reported perceived stress is associated
with a reduction in biochemical markers of stress which could explain the positive impact on
HbA1c. It is critically important to understand the physiologic as well as the psychosocial
mechanisms associated with such interventions in order to improve glycemic control in youth
with this chronic autoimmune condition. If such interventions affect biomarkers of stress, it
would be important to strengthen the stress reduction activities embedded in such
interventions, such as meditation, to further improve metabolic control. Thus, aims of this
pilot/feasibility study are to:

1. Determine the feasibility and reliability of collection of saliva for the measurement of
three stress biomarkers at awakening and 30-45 minutes later over 3 days at home in 20
youth (age 11-14 years). These biomarkers include cortisol to assess
hypothalamic-pituitary-adrenal axis functioning; alpha-amylase (s-AA) to assess the
sympathetic-adrenal-medullary system, and salivary immunoglobulin A (s-IgA) to assess
stress-related immune changes. This aim will allow the investigators to determine the
feasibility of recruiting youth to provide such data in a larger trial by assessing the
percent of youth who agree to participate and adhere to the salivary collection
protocol, using actigraphy to document awakening time and Medication Event Monitoring
System (MEMS) caps monitoring to determine time of salivary collection. Patterns and
variability of stress biomarker levels over 3 days will be used to assess
intra-individual variability and relationships with self-reported daily stressors and
self-reported perceived stress.

2. Conduct a pilot study of Teens.Connect, a combination of the investigators' previous
TEENCOPE™ and Managing Diabetes programs with 40 youth to determine whether alterations
in stress biomarkers are associated with self-reported perceived stress and HbA1c.

3. Assess epigenetic components of these responses by examining the gene-environment
interaction of the top 14 targeted candidate genes and epigenome wide effects of teens'
stress biomarkers and their influence on HbA1c levels over time. Candidate genes will be
measured at baseline and DNA methylation patterns will be measured at baseline and then
again at 6 months follow-up using the Oragene saliva collection kits.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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