Telemedicine + Gluten Detection Tech for Celiac Disease

(GLUTECH Trial)

Recruiting at 3 trial locations

Overseen By Benjamin Lebwohl, MD, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: Pregnancy, Not gluten-free diet, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

200 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, you cannot participate if you are in another clinical trial for an experimental drug.

What data supports the effectiveness of the treatment Telemedicine + Gluten Detection Tech for Celiac Disease?

During the COVID-19 pandemic, telemedicine was found to be feasible and trusted by most patients for managing celiac disease, and gluten detection tests were useful in confirming adherence to a gluten-free diet. Additionally, a portable gluten sensor, Nima™, showed high accuracy in detecting gluten, which can help individuals with celiac disease avoid gluten exposure. ^{1 2 3 4 5}

Is the combination of telemedicine and gluten detection technology safe for humans?

The use of telemedicine and gluten detection technology for monitoring celiac disease patients has been shown to be feasible and trusted by most patients, with no specific safety concerns reported in the studies. ^{2 3 4 6 7}

How does the treatment 'Telemedicine + Gluten Detection Tech for Celiac Disease' differ from other treatments for this condition?

This treatment is unique because it combines continuous remote health monitoring through telemedicine with gluten detection technology, allowing patients to manage their celiac disease by ensuring adherence to a gluten-free diet and detecting gluten contamination in real-time, which is not typically available in standard treatments. ^{1 2 3 4 8}

What is the purpose of this trial?

The investigators propose to plan for a multi-center randomized controlled trial (M-RCT) to test the effectiveness of novel gluten detection technologies as an adjunct to telemedicine to manage celiac disease in newly diagnosed adults. If successful, the proposed intervention will improve mucosal recovery, promote a shift in current practice of celiac disease management toward long-term monitoring, and represent a significant step toward reducing the severe physical and psychological consequences of celiac disease.

Research Team

Benjamin Lebwohl, MD, MS

Principal Investigator

Columbia University

Eligibility Criteria

Adults aged 18-75, recently diagnosed with celiac disease, who are willing to use gluten-detection technology and have had an initial dietitian visit at a participating center. They must not be pregnant or planning pregnancy during the study nor involved in another drug trial.

Inclusion Criteria

I have been diagnosed with celiac disease through blood tests and a biopsy showing specific changes in my intestine.

Willingness to use gluten-detection technology

Having already had an initial dietitian visit at one of the participating celiac disease centers

Exclusion Criteria

Not planning to follow a gluten-free diet

Concurrent participation in a clinical trial of an experimental pharmacologic agent (for any condition)

Currently pregnant or planning to become pregnant during the study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial assessment of participants' gastrointestinal symptoms, diet adherence, quality of life, and other baseline measures

1 week

Treatment

Participants receive either standard of care or standard of care plus gluten detection technology

12 months

Continuous telehealth follow-up

Follow-up

Participants are monitored for safety and effectiveness after treatment, including mucosal recovery and symptom assessment

4 weeks

Treatment Details

Interventions

• Continuous telemedicine monitoring
• Continuous telemedicine monitoring plus gluten detection technology

Trial Overview The effectiveness of using gluten detection technologies alongside telemedicine for managing celiac disease is being tested. This randomized controlled trial aims to see if this approach helps patients recover better and cope with the condition's challenges.

Participant Groups

Group I: Standard of Care Plus Technology Experimental Treatment 2 Interventions

In addition to standard of care, participants will be provided with gluten detection technology so as to assist in navigating the gluten-free diet.

Group II: Standard of Care Active Control 1 Intervention

Participants will be provided with continuous Telehealth dietitian follow-up

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Findings from Research

The Nima™ gluten sensor is a portable device that accurately detects gluten proteins at levels below the safe threshold of 20 ppm, making it a valuable tool for individuals with celiac disease to ensure food safety.

With a 99.0% true positive rate in detecting gluten, the Nima™ device demonstrates high sensitivity and reliability, significantly improving the ability of gluten-sensitive individuals to manage their dietary restrictions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An integrated, accurate, rapid, and economical handheld consumer gluten detector. Zhang, J., Portela, SB., Horrell, JB., et al.[2019]

Telemedicine was effectively used for monitoring celiac disease patients during the COVID-19 pandemic, with a high completion rate of 92.9% for scheduled televisits among symptomatic patients.

Patients showed strong trust in the telemedicine service, with over 94% expressing confidence in the system, and gluten detection tests were successfully utilized to confirm adherence to the gluten-free diet remotely.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional and Gastroenterological Monitoring of Patients With Celiac Disease During COVID-19 Pandemic: The Emerging Role of Telemedicine and Point-of-Care Gluten Detection Tests. Costantino, A., Roncoroni, L., Noviello, D., et al.[2021]

In a 3-month pilot study involving 30 participants with biopsy-confirmed coeliac disease, users of a portable gluten sensor reported increased assurance and control over their gluten-free diet, highlighting its potential as a helpful tool for managing coeliac disease.

However, participants also expressed concerns about the sensor's accuracy, physical difficulty in use, and social discomfort, indicating that while the sensor offers benefits, improvements are needed for user experience and reliability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Portable gluten sensors: qualitative assessments by adults and adolescents with coeliac disease. Wolf, RL., Vipperman-Cohen, A., Green, PHR., et al.[2021]

Testing cream cheese and similar dairy products for gluten using the NIMA sensor can lead to false positive results, particularly influenced by the weight and viscosity of the sample tested.

In controlled tests, all dairy materials were found to have gluten levels below the detection limit using standard ELISA methods, indicating that the NIMA sensor's results may not be reliable without careful consideration of sample preparation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consumer-Led Investigation into Potential Issues That Arise When Testing Dairy Matrixes for Gluten With the NIMA Sensor. Thompson, T., Rogers, A., Perry, J.[2023]

In a study of 13 patients with chronic diarrhea after gluten intake, 9 were diagnosed with celiac disease (CD) based on positive serological tests and intestinal biopsies, highlighting the importance of these tests for accurate diagnosis.

A gluten-free diet was effective for 12 out of 13 patients, demonstrating that strict adherence to this diet is crucial for managing CD and preventing symptoms, which can include increased bowel movements upon gluten re-exposure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical analysis of gluten-related disease]. Diao, M., Bao, J., Xu, Y.[2018]

Celiac disease, wheat sensitivity, and allergy affect about 7% of the global population, and the only effective treatment is a strict gluten-free diet, which is challenging due to the risk of gluten contamination in supposedly 'gluten-free' products.

Recent advancements in gluten detection methods, particularly those that identify immunogenic gluten peptides without antibodies, could significantly improve food safety for celiac patients by ensuring lower contamination levels in both raw and processed foods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gluten Detection Methods and Their Critical Role in Assuring Safe Diets for Celiac Patients. Osorio, CE., Mejías, JH., Rustgi, S.[2020]

A study analyzing 5,624 tests from a portable gluten detection device found that 32% of gluten-free labeled restaurant foods contained detectable gluten, highlighting a significant risk for individuals with celiac disease.

Gluten contamination was particularly high in gluten-free labeled pizza and pasta, with detection rates of 53.2% and 50.8%, respectively, suggesting that these foods should be approached with caution by those adhering to a gluten-free diet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Detection of Gluten in Gluten-Free Labeled Restaurant Food: Analysis of Crowd-Sourced Data. Lerner, BA., Phan Vo, LT., Yates, S., et al.[2020]

Celiac disease is a growing autoimmune disorder that primarily affects the small intestine and requires lifelong adherence to a gluten-free diet for management.

Biosensors represent a promising advancement in the detection of celiac disease biomarkers, offering a non-invasive, rapid, and cost-effective method for diagnosis and monitoring, which could improve patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biosensors for Non-Invasive Detection of Celiac Disease Biomarkers in Body Fluids. Pasinszki, T., Krebsz, M.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

An integrated, accurate, rapid, and economical handheld consumer gluten detector. [2019]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Nutritional and Gastroenterological Monitoring of Patients With Celiac Disease During COVID-19 Pandemic: The Emerging Role of Telemedicine and Point-of-Care Gluten Detection Tests. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Portable gluten sensors: qualitative assessments by adults and adolescents with coeliac disease. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Consumer-Led Investigation into Potential Issues That Arise When Testing Dairy Matrixes for Gluten With the NIMA Sensor. [2023]

5. China pubmed.ncbi.nlm.nih.gov

[Clinical analysis of gluten-related disease]. [2018]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Gluten Detection Methods and Their Critical Role in Assuring Safe Diets for Celiac Patients. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Detection of Gluten in Gluten-Free Labeled Restaurant Food: Analysis of Crowd-Sourced Data. [2020]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Biosensors for Non-Invasive Detection of Celiac Disease Biomarkers in Body Fluids. [2018]