Use of Oral Antidiabetic Agents in Hospitalized Patients With Diabetes
Overview
- Phase
- Phase 4
- Intervention
- Oral Anti-diabetes Drugs alone
- Conditions
- Diabetes Mellitus
- Sponsor
- Emory University
- Enrollment
- 260
- Locations
- 3
- Primary Endpoint
- Mean daily BG concentration
- Status
- Recruiting
- Last Updated
- 8 months ago
Overview
Brief Summary
This randomized controlled clinical trial will 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. The primary outcome of the study is to determine differences in glycemic control as measured by mean daily blood glucose concentration between oral antidiabetic medications and basal bolus therapy in hospitalized patients with type 2 diabetes (T2D).
Detailed Description
Hyperglycemia in the hospital is common and has been associated with increased hospital complications, length of stay, and mortality. Improving glycemic control has been shown to improve length of stay, multi-organ failure, systemic infections, as well as short- and long-term mortality. Clinical guidelines from professional organizations recommend the use of subcutaneous (SQ) insulin as the preferred therapy for glycemic control in general medical and surgical patients with T2D. This approach, however, is labor intensive requiring multiple daily insulin injections, costly, and associated with significant risk of iatrogenic hypoglycemia Over 75% of patients with T2D are treated with oral antidiabetic drugs (OADs) but due to the lack of safety and efficacy data from randomized controlled trials, clinical guidelines recommend stopping OADs during hospitalization. The current clinical guidelines have raised concerns with the use of OADs including risk of hypoglycemia with sulfonylureas, fluid retention and worsening of heart failure with thiazolidinediones, and risk of metformin-associated lactic acidosis in patients with severe renal impairment. However, several observational studies have reported that the use of OADs results in similar glycemic control without increased risk of complications compared to insulin regimens. A recent observational study that included 17,325 hospitalized patients with T2D, found that patients treated with OADs had similar glycemic control without differences in complications and no increase in rates of hypoglycemia compared to those treated with insulin. This study will 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 hospital patients with T2D. For a subset of participants (50 patients per group), a CGM devise will be placed for the duration of the study to assess parameters of glycemic control and hypoglycemia.
Investigators
Maya Fayfman
Associate Professor
Emory University
Eligibility Criteria
Inclusion Criteria
- •Males or females, age 18-80 years admitted to a general medicine and surgery services
- •Known history of T2D receiving OADs either as monotherapy or in combination therapy
- •Admission BG \< 250 mg/dl or randomization BG \<250 mg/dl and not receiving basal insulin
- •Patients receiving OADs in combination with GLP-1 receptor agonists (GLP-1RA) who have HbA1c \<7.5% within the past three months
- •HbA1c \<10%
Exclusion Criteria
- •No known history of diabetes
- •Laboratory evidence of diabetic ketoacidosis
- •Subjects with a history of type 1 diabetes (suggested by BMI \< 25 requiring insulin therapy or with a history of diabetic ketoacidosis, or ketonuria)
- •Meeting any exclusion criteria based on specific contraindications to their home oral therapy
- •Acute critical illness or cardiac surgery expected to require admission to a critical care unit
- •Gastrointestinal obstruction, adynamic ileus, or expected to require gastrointestinal suction
- •Medical or surgical patients expected to be kept NPO for \>24-48 hours after admission or after completion of surgical procedure
- •Impaired renal function (eGFR \<30 ml/min)
- •Current treatment with oral or injectable corticosteroid
- •Mental condition rendering the subject unable to understand the nature and scope of the study
Arms & Interventions
Oral Anti-diabetes Drugs (OADs) alone
OADs will be continued at same outpatient dosage unless contraindicated
Intervention: Oral Anti-diabetes Drugs alone
Oral Anti-diabetes Drugs (OADs) alone
OADs will be continued at same outpatient dosage unless contraindicated
Intervention: Supplemental insulin
Oral Anti-diabetes Drugs (OADs) alone
OADs will be continued at same outpatient dosage unless contraindicated
Intervention: Continuous glucose monitoring (CGM)
Basal bolus insulin
Basal insulin with glargine or detemir and rapid-acting insulin (lispro/aspart) will be used as per the hospital formulary. OADs and non-insulin injectable antidiabetic medication will be discontinued on admission.
Intervention: Basal bolus insulin
Basal bolus insulin
Basal insulin with glargine or detemir and rapid-acting insulin (lispro/aspart) will be used as per the hospital formulary. OADs and non-insulin injectable antidiabetic medication will be discontinued on admission.
Intervention: Supplemental insulin
Basal bolus insulin
Basal insulin with glargine or detemir and rapid-acting insulin (lispro/aspart) will be used as per the hospital formulary. OADs and non-insulin injectable antidiabetic medication will be discontinued on admission.
Intervention: Continuous glucose monitoring (CGM)
Outcomes
Primary Outcomes
Mean daily BG concentration
Time Frame: During hospital stay (up to 10 days)
Mean daily BG concentration will be compared between OADs and basal bolus therapy in hospitalized patients with T2D.
Secondary Outcomes
- Number of clinically significant hypoglycemic events(During hospital stay (up to 10 days))
- Glycemic variability in participants receiving CGM monitoring(During hospital stay (up to 10 days))
- Number of mild hypoglycemic events(During hospital stay (up to 10 days))
- Percent of BG within target range without hypoglycemia(During hospital stay (up to 10 days))
- Daily dose of insulin(During hospital stay (up to 10 days))
- Number of severe hypoglycemic severe (<40 mg/dl) events(During hospital stay (up to 10 days))
- Number of episodes of hyperglycemia after the first day of treatment(During hospital stay (up to 10 days))
- Number of patients using oral antidiabetic drugs (OADs) during hospitalization(During hospital stay (up to 10 days))
- OAD dose used during hospitalization(During hospital stay (up to 10 days))
- Time above BG target range (>180 mg/dl) 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(During hospital stay (up to 10 days))
- Number of hospital complications(During hospital stay (up to 10 days))
- Number of patients on OADs requiring insulin rescue therapy(During hospital stay (up to 10 days))
- Number of episodes of treatment failure(During hospital stay (up to 10 days))
- Number of individual hospital complications(Up to 40 days (hospital stay plus 30 days after discharge))
- Length of hospital stay(During hospital stay (up to 10 days))
- Costs for diabetes specific therapies(During hospital stay (up to 10 days))
- Time below BG target range (BG <70 mg/dl) in participants receiving CGM monitoring(During hospital stay (up to 10 days))
- In-hospital mortality(During hospital stay (up to 10 days))
- Hospital costs(During hospital stay (up to 10 days))
- Number of hospital re-admissions(within 30 days of hospital discharge)
- Number of emergency room visits(within 30 days of hospital discharge)
- Number of participants requiring ICU care(During hospital stay (up to 10 days))
- Nursing antihyperglycemic drug preference survey(Day of hospital discharge (up to 10 days))
- Patient antihyperglycemic drug preference survey(Day of hospital discharge (up to 10 days))