260
Participants
Start Date
August 7, 2020
Primary Completion Date
April 30, 2026
Study Completion Date
May 31, 2026
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.
Basal bolus insulin
Basal insulin with glargine or detemir will be used as per the hospital formulary.
Supplemental insulin
Supplemental (correction) lispro or aspart insulin following the supplemental/sliding scale standard of care protocol for BG \>140 mg/dl.
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."
RECRUITING
Emory University Hospital Midtown, Atlanta
RECRUITING
Emory University Hospital, Atlanta
RECRUITING
Grady Memorial Hospital, Atlanta
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Emory University
OTHER