Oral Anti Diabetic Agents in the Hospital

PHASE4RecruitingINTERVENTIONAL
Enrollment

260

Participants

Timeline

Start Date

August 7, 2020

Primary Completion Date

April 30, 2026

Study Completion Date

May 31, 2026

Conditions
Diabetes Mellitus
Interventions
DRUG

Oral Anti-diabetes Drugs alone

OADs will be continued at same outpatient dosage unless contraindicated. Participants will be switched to the preferred drug within the category of medication they take at home. Dose adjustment for OADs will be based on clinical/laboratory status. The OAD will be held if the participant is placed on strict nil per os (NPO) and is unable to take oral medications after enrollment.

DRUG

Basal bolus insulin

Basal insulin with glargine or detemir will be used as per the hospital formulary.

DRUG

Supplemental insulin

Supplemental (correction) lispro or aspart insulin following the supplemental/sliding scale standard of care protocol for BG \>140 mg/dl.

DEVICE

Continuous glucose monitoring (CGM)

"A subset of participants (50 per study arm) will be randomized to take part in an optional study where a CGM device will be placed for the duration of the study. CGM reports will be reviewed at the end of the study to assess parameters of glycemic control and hypoglycemia, and not used for insulin dose adjustment.~The Dexcom CGM is a small sensor that inserts just under the skin to continuously monitor glucose levels. Results are transmitted to the wearer's smartphone every five minutes."

Trial Locations (3)

30322

RECRUITING

Emory University Hospital Midtown, Atlanta

RECRUITING

Emory University Hospital, Atlanta

RECRUITING

Grady Memorial Hospital, Atlanta

All Listed Sponsors
collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

lead

Emory University

OTHER