Mother and Son in Kitchen
T1D+Ced Diabetes+Celiac Research Study
Join research on a new option to
treat symptoms for people diagnosed with both
type 1 diabetes
and celiac disease.

The Diabetes + Celiac Research Study

About the Trial

The T1D+CeD Research Study is a paid clinical trial for individuals diagnosed with both celiac disease (CeD) and type 1 diabetes (T1D). 

The study is being conducted at Stanford University, Palo Alto, CA, and is researching whether an investigational medication can help reduce symptoms of accidental gluten exposure in such individuals.

Eating Healthy

A Dueling Dual Diagnosis

Celiac disease occurs 4 to 11 times more often in people diagnosed with type 1 diabetes than the general population.

 

In recent years, physicians have recommended that patients diagnosed with type 1 diabetes also be screened for celiac disease.
 

If you have been diagnosed with both conditions, you may have learned to make adjustments in your every day life. But eating can still be a challenging, misunderstood, and lonely struggle.


Though there are multiple ways to manage type 1 diabetes, there is only the one “treatment” for celiac disease: the gluten-free diet.

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But what if the gluten-free diet is not enough?

 
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New medications are being developed to address this gap

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Collaborators

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Study conducted at Stanford University under Professor and Chief of Pediatric Endocrinology and Diabetes, Dr. David Maahs.

 

Learn more about Dr. Maahs and the research team

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Science Student

A New Hope for a Unique Group

The study medication is called “latiglutenase” and is a combination of 2 enzymes specific for gluten. This means that, when eaten with a meal containing a small amount of gluten, latiglutenase breaks down gluten proteins.

The study medication is designed to be used alongside a gluten-free diet and reduce symptoms of accidental gluten exposure (a.k.a., cross-contamination or cross-contact).

If you are between 14-80 years old and diagnosed with both T1D and celiac disease*, joining the T1D+CeD Research Study offers the opportunity to try this investigational medication under the oversight of leading physician-researchers.

 

What happens during the T1D+CeD Study?

Screening: After passing the pre-screening period, you will be asked to provide medical records, undergo physical exams and a few lab tests, record your celiac-related symptoms, and complete other study activities over 2 months.

Completion: After completing all study visits (up to 8 visits over 34 weeks total) and assessments, you will have completed the study. Compensation is provided at the end of each visit.

Pre-screen: Complete the online pre-screener so our study team can determine if you are eligible to participate. If you are eligible, a study team member will reach out to you within a few days to verify eligibility.

Participation: After passing the screening period, you will come in for 5 more visits over 24 weeks to complete study assessments, including urine tests and HbA1C measurements. You will be provided masked study medication and also be asked to consume a study-provided snack weekly.

Study Results: The study is closed once the target number of study participants have enrolled and completed all study visits. When results are available, they will be published to ClinicalTrials.gov and/or in a peer-reviewed article by the collaborating institutions.

*Questions? Check out our FAQ

 

Qualifications

Additional inclusion and exclusion criteria apply

Diagnosed with both celiac disease and type 1 diabetes

Following a gluten-free diet for at least the past 12 months

Willing to occasionally eat a study-provided minimal gluten-containing snack less than once weekly for 28 weeks.

Between 14 and 80 years of age

Still experiencing at least moderate symptoms despite following a gluten-free diet

Willing and able to come to the research clinic for 8 visits over 34 weeks

If you meet the above criteria, you may qualify. Click below to start the pre-screener and get connected with a study team member to learn more.

 

See if you Qualify

 
 

Resources

Study Flyers

Download our study flyers to share with your primary care doctor, specialty physician, or friends and family.

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Contact & Questions

If you still have questions, check out our FAQ section.

 

If you would like to speak to someone about the study, reach out to one of our friendly study team members anytime at:

 

info@diabetesceliacstudy.com

If you want to complete the questionnaire in a new window, click here.