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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Pilot Study to Test the Feasibility and Acceptability of Using a Gluten Sensor Device to Promote Gluten Free Diet Adherence and Quality of Life in Patients With Celiac Disease

Conditions
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Celiac Disease

Intervention / Treatment
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* Other: Gluten Sensor Dose-Finding Intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Light use of Nima<br>Ten participants will be randomized to receive 12 capsules every other month (18 capsules for the 3 months which is considered light use). | Other: Gluten Sensor Dose-Finding Intervention<br>* 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.<br>* Other names: Nima;|
| Experimental: Moderate use of Nima<br>Ten participants will be randomized to receive 12 capsules per month (36 capsules for the 3 months which is considered moderate use). | Other: Gluten Sensor Dose-Finding Intervention<br>* 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.<br>* Other names: Nima;|
| Experimental: Heavy use of Nima<br>Ten participants will be randomized to receive 24 capsules per month (72 capsules for the 3 months which is considered heavy use). | Other: Gluten Sensor Dose-Finding Intervention<br>* 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.<br>* Other names: Nima;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life measure | A 20-item Celiac Disease-Quality of Life (CD-QOL) survey or 17-item Celiac Disease Pediatric Quality of (CDPQOL) survey. Each of these scales ranges from a minimum of 0 (lowest quality of life) to 100 (highest quality of life). | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression | The 21 item Beck Depression Inventory (BDI). This depression scale ranges from 0 (fewer symptoms) to 60 (most symptoms). | 3 months | 
| Adherence to the gluten-free diet | A 7-item validated CD adherence test (CDAT) survey. Higher scores suggest worse adherence (with scores >13 indicative of poor adherence) | 3 months | 
| Celiac disease symptoms | Celiac Disease Symptom Diary (CDSD) | 3 months | 
| Anxiety | 21 item Beck Anxiety Inventory. This anxiety index ranges from 20 (lower anxiety) to 100 (greater anxiety). | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gluten Free diet