This study will evalute the effect of a low glycemic load (LGL diet on dysglycemia, insulin requirements, DXA-derived body composition, gastrointestinal symptoms and quality of life measures in adults with cystic fibrosis-related diabetes (CFRD). We will use continuous glucose monitors (CGM) to assess the LGL diet both in a controlled setting (via a meal delivery company) and in free-living conditions.
18 years and above
Genetically confirmed diagnosis of CF
Diagnosis of pancreatic insufficiency, requiring pancreatic enzyme replacement
FEV1 <50% predicted on most recent pulmonary function testing
BMI <18 kg/m2
Currently receiving enteral nutrition support via GT feeds
Pregnancy, plan to become pregnant in the next 3-months, or sexually active without use of contraception
Sequential
Low Glycemic Load Diet
BehavioralFood delivery service will provide a low glycemic load diet for 8 weeks, followed by a 4-month period of self-adherence to a low glycemic load diet with close nutritionist follow up
Change in percent time in target range 70-180 mg/dL
Continuous glucose monitoring
Change in CGM average glucose (AG) mg/dL
Continuous glucose monitoring
Change in percent time >180 mg/dL
Continuous glucose monitoring
Change in percent time >250 mg/dL
Continuous glucose monitoring
Change in CGM standard deviation (SD)
Continuous glucose monitoring
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Rhode Island Hospital
Lead sponsor
Cystic Fibrosis Foundation
Collaborator
