Study to Determine the Efficacy of Real-time CGM in Preventing Hypoglycemia Among Insulin-treated Patients With DM2 on Hemodialysis, Compared to Standard of Care (POC BG)

NACompletedINTERVENTIONAL
Enrollment

53

Participants

Timeline

Start Date

November 5, 2020

Primary Completion Date

October 31, 2023

Study Completion Date

October 31, 2023

Conditions
End-Stage Renal DiseaseType 2 Diabetes
Interventions
DEVICE

Dexcom Real-time G6 Continuous Glucose Monitoring System (CGM)

"Dexcom G6, a factory-calibrated CGM system, is innovative in many aspects: 1) it does not require finger stick POC BG for calibration, 2) the sensor is small, compact, light-weight, 3) has no interference with several substance and drugs, and 4) protective urgent low soon alarm, with proven prediction of hypoglycemia within 20 minutes in advance.~Dexcom G6 monitors glucose continuously (24 hrs) and displays real-time glucose values, glucose trends/arrows and alarms, including the urgent low soon alarm (predictive of hypoglycemia \< 55 mg/dL within the preceding 20 minutes).~Diagnostic Test: Real-time CGM will be used to collect outcomes variables"

DEVICE

POC Glucose Testing

"POC BG (standard of care) uses commercially-available glucose meters for blood glucose monitoring. It is approved to be used in dialysis populations.~Diagnostic Test: Professional CGM will be used to collect outcomes variables (including during the POC BG testing)."

Trial Locations (2)

30322

Emory Clinic, Atlanta

Grady Health System (non-CRN), Atlanta

All Listed Sponsors
collaborator

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

NIH

lead

Emory University

OTHER

NCT04473430 - Study to Determine the Efficacy of Real-time CGM in Preventing Hypoglycemia Among Insulin-treated Patients With DM2 on Hemodialysis, Compared to Standard of Care (POC BG) | Biotech Hunter | Biotech Hunter