Using oral diabetes medications in the hospital instead of insulin
Use of Oral Antidiabetic Agents in Hospitalized Patients With Diabetes
This study is testing if using oral diabetes medications instead of insulin during hospital stays can help people with type 2 diabetes manage their blood sugar better.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 260 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Emory University Academic / other |
| Locations | 3 sites (Atlanta, Georgia and 2 other locations) |
| Trial ID | NCT04416269 on ClinicalTrials.gov |
What this trial studies
This randomized controlled clinical trial evaluates the safety and effectiveness of continuing home oral antidiabetic agents (OADs) during hospitalization for managing diabetes, as an alternative to insulin therapy. The study focuses on hospitalized patients with type 2 diabetes (T2D) and aims to compare glycemic control, measured by mean daily blood glucose levels, between those receiving OADs and those on basal bolus insulin therapy. Given the common occurrence of hyperglycemia in hospitals and its associated risks, this trial seeks to provide evidence that could change current clinical guidelines regarding diabetes management in hospitalized patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 with a known history of type 2 diabetes who are currently on oral antidiabetic medications.
Not a fit: Patients with type 1 diabetes, those with acute critical illnesses, or those requiring intensive care are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more convenient method for managing diabetes in hospitalized patients, potentially reducing complications and length of stay.
How similar studies have performed: Observational studies have suggested that using OADs can achieve similar glycemic control as insulin without increased complications, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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 * 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 admission
Where this trial is running
Atlanta, Georgia and 2 other locations
- Emory University Hospital Midtown — Atlanta, Georgia, United States (Recruiting)
- Emory University Hospital — Atlanta, Georgia, United States (Recruiting)
- Grady Memorial Hospital — Atlanta, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: Maya Fayfman, MD — Emory University
- Study coordinator: Maya Fayfman, MD
- Email: maya.fayfman@emory.edu
- Phone: 404-778-1664
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.