Celiac Disease and Diabetes Longitudinal Follow-up and Evaluation Study

Study Overview
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Brief Summary
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To the investigators' knowledge, no single long-term prospective observational study has assessed dietary factors, diabetes clinical variables (metabolic control and associated complications), and self -perceived health and wellness in T1D patients (both pediatric and adult) with CD identified by screening (positive/weakly positive serology). The aim of the current study is to observe the short- and long-term outcomes for Type 1 diabetic patients with new serology positive asymptomatic CD.

Official Title
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Celiac Disease and Diabetes Longitudinal Follow-up and Evaluation Study (CD-LiFE)

Conditions
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Celiac, Celiac Disease, Diabetes Mellitus, Type 1

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females between the ages of 8 and 50 years with positive/weakly positive serologic CD screening or who have completed the CD-DIET trial. Diagnosis of T1D by American Diabetes Association (ADA) criteria with duration of T1D equal to or greater than 1 year from time of signing Screening Informed Consent for CD-DIET trial. Ability of the subject or a legally authorized representative to speak and read English or French. Participation in the screening portion of the CD-DIET Study. Exclusion Criteria: 1. A condition which, in the opinion of the investigator, may interfere with the subject's ability to participate in the study.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 50 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CD-DIET Gluten-Free Diet Group<br>This former randomized control trial (RCT) group received a gluten-free education and continued support from a dietitian for a 1-year period via the CD-DIET Study (NCT01566110) | |
| CD-DIET Gluten-Containing Diet Group<br>This former RCT group did not receive a gluten-free education and 1-year support from a dietitian via the CD-DIET Study (NCT01566110), but rather a single gluten-free education session upon exiting the study. | |
| CD-DIET Ineligibles/Refusals<br>This group contains T1D/CD individuals who were not eligible or refused to join the CD-DIET RCT (e.g. already self-selected their diet or had no interest in being randomized). These individuals were instead redirected to the clinical route. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Daily Gluten Intake | This outcome will be measured through interview/assessment data. | 2 Years | 
| Celiac Dietary Adherence | This outcome will be measured through the Celiac Dietary Adherence test (CDAT) questionnaire. | 2 Years | 
| TTG-IgA Serology | This outcome will be measured through TTG-IgA serology testing for inflammatory markers for celiac disease. | 2 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related Quality of Life | This outcome will be measured through the self-reported Quality of Life (PedsQL) Inventory Generic Core Scale (V.4.0) with Diabetes Module (V.3.0). | 2 Years | 
| Daily Activity Levels | This outcome will be measured through the self-reported Habitual Activity Estimation Scale (HAES). | 2 Years | 
| Self-Perceived Wellness | This outcome will be measured through a self-reported Self-Perceived Wellness Scale. | 2 Years | 
| Metabolic Control | This outcome will be measured through self-reports and lab-provided HbA1c values. | 2 years | 
| Kidney Function | This outcome will be measured through lab-provided Albumin/Creatinine Ratios. | 2 years | 
| Hypoglycemic episodes. | The frequency and severity of hypoglycemic episodes will be recorded at each clinic visit via self-report. | 2 years | 
| Presence of Type 1 Diabetes Complications | This outcome will be measured by monitoring the occurence of T1D health outcomes and complications over time through long-term medical record review follow-up. Complications include, but are not limited to: nephropathy, retinopathy, and cardiovascular disease in the study population. | 10 years | 
| Presence of Celiac Disease Complications | This outcome will be measured by monitoring the occurence of celiac disease health outcomes and complications over time through long-term medical record review follow-up. Complications include, but are not limited to: osteoporosis and malnutrition in the study population. | 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatric, dietary treatment, celiac disease, T1D