Oral Anti Diabetic Agents in the Hospital (NCT04416269) | Clinical Trial Compass
Active — Not RecruitingPhase 4
Oral Anti Diabetic Agents in the Hospital
United States255 participantsStarted 2020-08-07
Plain-language 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).
Who can participate
Age range18 Years – 80 Years
SexALL
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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
* Female subjects who are pregnant or breastfeeding at time of enrollment in the study
* New or recent onset (within two weeks) of coronavirus disease 2019 (COVID-19) infection at the time of ad…