Gluten Sensor Device to Promote Gluten Free Diet Adherence and Quality of Life in Patients With Celiac Disease

Little is known about the best ways to promote a strict gluten-free diet while maximizing
quality of life in teenagers and adults with celiac disease. The aim of the proposed pilot is
to assess the acceptability and feasibility of a novel intervention - a portable gluten
sensor device. The sample for this pilot will be 30 teenagers and adults with biopsy
confirmed celiac disease recruited from the Celiac Center at Columbia University in New York
City. Thirty participants will pilot test a portable gluten sensor device with its associated
iPhone app for 3 months. At baseline and three-month follow-up, participants will complete
measures of gluten free diet adherence, quality of life,symptoms, anxiety, and depression. At
post-only, the investigators will collect in-depth data related to the feasibility and
acceptability of the gluten sensor, as well as facilitators and barriers related to how,
where, and when it was used. At the completion of the proposed pilot study, the investigators
hope to have preliminary data to inform development of gluten sensor interventions that the
investigators hope to test in a larger NIH-funded randomized controlled trial. These
findings, in combination with a larger trial, have the potential for the development of a new
standard of care in the management of patients with celiac disease.

Inclusion Criteria:

- Individuals >13 years old (15 teenagers and 15 adults), 30 in total with duodenal
biopsy-confirmed diagnosis of celiac disease will be recruited to participate.

- As we are testing a gluten sensor device, we require that participants are 13 years or
older as they will need to be able to operate the gluten sensor device independently

Exclusion Criteria:

- No participants will be excluded based on gender, race or ethnicity.

- Patients diagnosed with celiac disease without a duodenal biopsy.