The Role of Sleep Deficiency in Persons with Type 1 Diabetes: Sleep, Glycemic Control, and Cardiovascular Risk (R34 Clinical Trial Optional)

This NOFO will support preliminary studies aimed to obtain information necessary to guide the design of a full randomized control trial to test whether sleep and circadian targeted interventions improve the clinical course and treatment outcomes in individuals with Type 1 Diabetes (T1D). Applications should focus on pilot studies to inform practical and potentially sustainable strategies to improve processes of care and cardiometabolic health outcomes in individuals with T1D. The scope of research for this NOFO includes a range of feasibility metrics (e.g., optimizing recruitment, retention, randomization); intervention logistics (e.g., determine independent variable(s), dose-response, duration); study design/statistical considerations (e.g., determination of effect size, sample size, and statistical power; inclusion/exclusion criteria, control variables); adherence outcomes (measures of patient acceptance of, satisfaction with, and adherence to treatment); assessment of intermediate markers of the intervention (e.g. glycemic control, vascular dysfunction, inflammation, and/or neuroendocrine and metabolic function); and selection of primary and/or secondary outcome(s) measures. Ultimately, results from these pilot studies will be used to develop a well-powered, evidence-based definitive clinical trial that could improve clinical care and cardiometabolic outcomes in individuals with T1D and to inform guidelines for this patient population. Transdisciplinary investigative teams including relevant expertise in sleep/circadian, T1D and cardiovascular research, as well as needed expertise in clinical trial design, biostatistics and other appropriate areas are encouraged. Studies should include active participation of children, adolescents, and/or adults with T1D. This program is not intended to develop or validate new treatments of devices for sleep and/or circadian deficiency. Animal studies will not be considered responsive to this initiative.
Categories: Health.