This FOA invites applications for a Biostatistics Research Center (BRC) to participate in a clinical consortium to determine the factors that contribute to the heterogeneity in the restoration of impaired awareness of hypoglycemia (IAH) and improved counter-regulatory responses in adult individuals with Type 1 Diabetes (T1D) and impaired awareness of hypoglycemia (IAH). A separate FOA (RFA-DK-21-020) invites Clinical Centers to: 1) determine if the most up-to-date diabetes technology to optimize HbA1c while minimizing hypoglycemia can restore awareness of hypoglycemia and improve counter-regulatory responses in individuals with T1D and IAH; 2) identify the magnitude and duration of time in range (TIR), time spent in hypoglycemia or other CGM metrics that are associated with restoration of awareness of hypoglycemia; and 3) determine the association of current or newly developed self-reported measures of IAH with counter-regulatory responses to elucidate the heterogeneity in restoration of hypoglycemia awareness.
All awardees will form a cooperative research consortium in conjunction with NIDDK to design and implement a uniform protocol across what is expected to be 10 Clinical Centers and the BRC. Findings from this clinical trial are expected to make a significant contribution to our understanding of the physiological factors which contribute to restoration of impaired awareness of hypoglycemia and be used to tailor treatment regimens for adult individuals with T1D and IAH.
Deadlines:
Letter of Intent Due Date(s): March 01, 2022
Application Due Date: March 31, 2022
RFA-DK-21-036 Expiration Date April 01, 2022
Application budgets need to reflect the actual needs of the proposed project. Application awards are limited to $500,000 Direct Costs in grant year 1; $1,000,000 Direct Costs in grant year 2; $1,000,000 Direct Costs in grant year 3, $1,000,000 Direct Costs in grant year 4 and $1,000,000 in Direct costs in grant year 5.
