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Clinical Trial Details

Trial ID: L3970
Source ID: NCT04416269
Associated Drug: Oral Anti-Diabetes Drugs Alone
Title: Oral Anti Diabetic Agents in the Hospital
Acronym:
Status: RECRUITING
Study Results: NO
Results:
Conditions: Diabetes Mellitus
Interventions: DRUG: Oral Anti-diabetes Drugs alone|DRUG: Basal bolus insulin|DRUG: Supplemental insulin|DEVICE: Continuous glucose monitoring (CGM)
Outcome Measures: Primary: Mean daily BG concentration, Mean daily BG concentration will be compared between OADs and basal bolus therapy in hospitalized patients with T2D., During hospital stay (up to 10 days) | Secondary: Number of mild hypoglycemic events, Mild hypoglycemic events are defined as BG \<70 mg/dl. Hypoglycemic events are assessed by point of care (POC) testing and continues glucose monitoring (CGM)., During hospital stay (up to 10 days)|Number of clinically significant hypoglycemic events, Clinically significant hypoglycemic events are defined as BG \<54 mg/dl. Hypoglycemic events are assessed by POC testing and CGM., During hospital stay (up to 10 days)|Number of severe hypoglycemic severe (<40 mg/dl) events, Severe hypoglycemic events are defined as BG \<40 mg/dl. Hypoglycemic events are assessed by POC testing and CGM., During hospital stay (up to 10 days)|Percent of BG within target range without hypoglycemia, The percentage of BG values within the target range of 70-180 mg/dl and without hypoglycemia will be compared between study arms., During hospital stay (up to 10 days)|Number of episodes of hyperglycemia after the first day of treatment, The number of episodes of hyperglycemia (BG \> 280 mg/dl) after the first day of treatment will be compared between study arms., During hospital stay (up to 10 days)|Daily dose of insulin, The total daily dose of insulin will be compared between study arms., During hospital stay (up to 10 days)|Number of patients using oral antidiabetic drugs (OADs) during hospitalization, The number of participants using OADs during hospitalization use will be recorded., During hospital stay (up to 10 days)|OAD dose used during hospitalization, Dosage of OADs used during hospitalization will be recorded., During hospital stay (up to 10 days)|Number of patients on OADs requiring insulin rescue therapy, The number of patients on OADs requiring insulin rescue therapy will be recorded, During hospital stay (up to 10 days)|Number of episodes of treatment failure, Treatment failure is defined as mean daily BG \> 240 mg/dl or 3 consecutive BG \> 240 mg/dl., During hospital stay (up to 10 days)|Glycemic variability in participants receiving CGM monitoring, Glycemic variability will be measured using the coefficient of variation, During hospital stay (up to 10 days)|Time above BG target range (>180 mg/dl) in participants receiving CGM monitoring, The percentage of time above BG target range (\>180 mg/dl) will be assessed in participants receiving CGM monitoring., During hospital stay (up to 10 days)|Time in BG target range (70-180 mg/dl) in participants receiving CGM monitoring, The percentage of time in the BG target range (70-180 mg/dl) will be assessed in participants receiving CGM monitoring., During hospital stay (up to 10 days)|Time below BG target range (BG <70 mg/dl) in participants receiving CGM monitoring, The percentage of time below BG target range (BG \<70 mg/dl) will be assessed in participants receiving CGM monitoring., During hospital stay (up to 10 days)|Number of hospital complications, Hospital complications is assessed as a composite variable including infectious, renal, pulmonary, neurologic, cardiovascular complications, and mortality., During hospital stay (up to 10 days)|In-hospital mortality, In-hospital mortality will be recorded will be compared between study arms., During hospital stay (up to 10 days)|Number of individual hospital complications, Number of individual hospital complications will be compared between study arms. The specific complications assessed for this outcome include acute respiratory failure, acute renal failure (incremental rise in creatinine by 0.5 mg/dL from baseline), infection during hospitalization not felt to be present on admission (including wound infection, urinary tract infection, bacteremia), myocardial infarction, cardiac arrhythmia, congestive heart failure, and cardiac arrest., Up to 40 days (hospital stay plus 30 days after discharge)|Hospital costs, Total hospital costs will be compared between study arms., During hospital stay (up to 10 days)|Length of hospital stay, Length of hospital stay, in days, will be compared between study arms., During hospital stay (up to 10 days)|Costs for diabetes specific therapies, Costs for diabetes specific therapies (including insulin, oral agents, and cost of injection administration) will be compared between study arms., During hospital stay (up to 10 days)|Number of hospital re-admissions, Number of hospital re-admissions within 30 days of hospital discharge will be compared between study arms., within 30 days of hospital discharge|Number of emergency room visits, Number of emergency room visits within 30 days of hospital discharge will be compared between study arms., within 30 days of hospital discharge|Number of participants requiring ICU care, The number of participants transferred to the ICU will be compared between study arms., During hospital stay (up to 10 days)|Nursing antihyperglycemic drug preference survey, The nurse who provided the most care for the participant during hospitalization completed a 7-item survey assessing antihyperglycemic drug preference. Nurses indicate if they agree or disagree with statements related to patient outcomes, workload requirements of insulin therapy, and perceived usefulness and safety of OADs. A summary score is not calculated for this qualitative survey., Day of hospital discharge (up to 10 days)|Patient antihyperglycemic drug preference survey, Participants will complete a 2 to 5-item survey assessing preferences of antihyperglycemic medications while hospitalized. Participants indicate if they agree or disagree with statements about OAD and insulin use during hospital stays, timely administration of insulin, and concerns about low blood sugar. A summary score is not calculated for this qualitative survey., Day of hospital discharge (up to 10 days)
Sponsor/Collaborators: Sponsor: Emory University | Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 260
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2020-08-07
Completion Date: 2025-07-01
Results First Posted:
Last Update Posted: 2024-12-12
Locations: Emory University Hospital Midtown, Atlanta, Georgia, 30322, United States|Emory University Hospital, Atlanta, Georgia, 30322, United States|Grady Memorial Hospital, Atlanta, Georgia, 30322, United States
URL: https://clinicaltrials.gov/show/NCT04416269