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 range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.