This multicenter trial engaged with over 30 diabetes clinics and screened over 2500 adults and children with type 1 diabetes for celiac disease. It also included a randomized dietary intervention study with a multiple outcomes, including impact on diabetes (metabolic) control (published in Diabetes Care 2020), quality of life (Journal of Clinical Endocrinology and Metabolism) and screening outcomes (American Journal of Gastroenterology. Additional manuscripts relating to the dietary outcomes, symptom complex presentation and bone health are underway.
These results have impacted clinical practice such that 1) adults are a high-risk population for celiac disease screening, 2) current screening practices that target symptomatic patients only are inadequate, 3) current screening thresholds we reported need to be used with this clinical population and 4) treatment with a gluten-free diet is associated with worsening of diabetes control and was well tolerated by patients, with no negative impact on wellbeing.
Clinical trial information: https://clinicaltrials.gov/ct2/show/NCT01566110
A follow-up study (CD-LiFE) for the interventional study was also established and funded (Physician Services Incorporated, PSI) and will be reporting longer term outcomes from this cohort.