Observational and prospective studies have reported on the association between hyperglycemia in the hospital and higher rates of hospital complications, mortality, and longer length of stay. Insulin therapy has been demonstrated to be effective in improving glycemic control and reducing complications among hospitalized patients. Insulin use, however, is associated with high rates of hypoglycemia, is cumbersome to administer (up to 4 injections daily), prone to error if not administered at appropriate times and may not inform optimal treatment for discharge. Several randomized controlled trials have demonstrated safety and efficacy of non- insulin therapies in the management of hyperglycemia in the hospital. No studies to date, however, have systematically evaluated a broad range of oral antidiabetic drugs (OAD) in the hospital setting. Accordingly, we propose a randomized controlled pragmatic clinical trial to compare continuation of home OADs to basal bolus insulin among hospitalized patients admitted to non-ICU services. Our goal is to determine whether OADs in patients with mild to moderate hyperglycemia can be continued during hospitalization to achieve similar glycemic control to basal bolus insulin without leading to increased hospital complications or higher costs. The findings of this real-world study will directly inform clinical care in the management of diabetes in the hospital. In addition, this proposal will enhance the multifaceted research training and career development plan necessary for Dr. Fayfman to become an independent clinical investigator. Dr. Fayfman will continue to work alongside an experienced mentoring and advisory team with expertise in clinical trials in hospital settings, biostatistics, and health economics. This training is supported by an institutional commitment to establishing interdisciplinary research collaborations and advancing Dr. Fayfmans? career in academic research.

Public Health Relevance

Hyperglycemia in the hospital is common and has been associated with increased hospital complications, length of stay, and mortality. Insulin therapy has been shown in randomized controlled trials to be effective reducing hyperglycemia and hospital complications but is cumbersome and contributes to rising health care costs. We propose a randomized controlled trial to assess whether continuation of home oral antidiabetic agents during hospitalization can be used as a safe and effective alternative to insulin therapy in the management of diabetes in the hospital.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Mentored Patient-Oriented Research Career Development Award (K23)
Project #
1K23DK124647-01
Application #
9953471
Study Section
Kidney, Urologic and Hematologic Diseases D Subcommittee (DDK)
Program Officer
Lee, Christine G
Project Start
2020-06-01
Project End
2025-03-31
Budget Start
2020-06-01
Budget End
2021-03-31
Support Year
1
Fiscal Year
2020
Total Cost
Indirect Cost
Name
Emory University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
066469933
City
Atlanta
State
GA
Country
United States
Zip Code
30322