Gluten Sensor Device to Promote Gluten Free Diet Adherence and Quality of Life in Patients With Celiac Disease
Condition: Celiac Disease
MeSH terms: Celiac Disease
Study type: Interventional

Summary: 
      The current treatment for celiac disease is a strict 100% gluten free diet. Little is known
      about the best way to promote adherence to such a strict diet and how to maximize quality of
      life at the same time.

      This pilot will look at the utility of a new innovation to promote gluten free diet adherence
      - a portable gluten sensor device. Participants will be 30 teenagers and adults with celiac
      disease recruited from the Celiac Disease Center at Columbia University in New York City.
      Before and after the intervention, participants will be asked about their adherence to a
      gluten free diet, quality of life, symptoms, and feelings of anxiety, and depression. This
      pilot data will help to inform interventions that the investigators hope to test in a larger
      NIH-funded trial to better understand the best ways to promote adherence and quality of life
      in celiac patients.
    

Detailed description: 
      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.
    

Intervention name(s): Gluten Sensor Dose-Finding Intervention
Intervention type(s): Other
Intervention description(s): Nima is a small portable sensor that detects gluten in a small amount of liquid and solid foods in about three minutes. Nima combines an electronic sensor with antibody-based detection in a disposable capsule. Nima displays a "smiley face" if the food or beverage is < 20 ppm or a wheat icon for > 20 ppm (low or high gluten).
Each of the 30 participants will receive a Nima along with 3 months of disposable capsules. At the baseline visit, research staff will provide participants with the Nima and capsules and review instructions on how to properly use the device with all participants.
Other intervention name(s): Nima
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gluten Free diet