The study is conducted to assess the efficacy of real-time CGM data in preventing hypoglycemia in patients with type 2 diabetes and end-stage kidney disease (ESKD), treated with insulin therapy and receiving hemodialysis.
The study is conducted to assess the efficacy of real-time CGM data in preventing hypoglycemia among patients with type 2 diabetes (DM2), treated with insulin and receiving hemodialysis. The study will provide novel insights into the glycemic exposure patterns among dialysis patients and will provide preliminary data for future outcomes-based studies determining the best glycemic targets for this group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
53
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
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).
Emory Clinic
Atlanta, Georgia, United States
Grady Health System (non-CRN)
Atlanta, Georgia, United States
Differences in Mean Percentage Time-in-hypoglycemia (< 70 mg/dL)
Differences in mean percentage time-in-hypoglycemia (\< 70 mg/dL) during the intervention phase in both groups (i.e. Real-time Dexcom CGM During CGM Intervention vs. Professional Dexcom CGM During Point-of-Care Glucose Intervention), as measured by CGM. Participants will use either CGM or POC BG testing (during each assignment phase) for insulin adjustment. CGM will be used to collect outcomes variables during each phase (including during the POC BG testing).
Time frame: 8 weeks (after completion of both phases)
% Time in Target Range (70-180 mg/dl)
% time in target range (70-180 mg/dl) during the intervention phase in both groups (i.e. Real-time Dexcom CGM During CGM Intervention vs. Professional Dexcom CGM During Point-of-Care Glucose Intervention), as measured by CGM. Participants will use either CGM or POC BG testing (during each assignment phase) for insulin adjustment. CGM will be used to collect outcomes variables during each phase (including during the POC BG testing).
Time frame: 8 weeks (after completion of both phases)
Mean % Time in Hypoglycemia (< 54 mg/dL)
% time in hypoglycemia (\<54 mg/dL) during the intervention phase in both groups (i.e. Real-time Dexcom CGM During CGM Intervention vs. Professional Dexcom CGM During Point-of-Care Glucose Intervention), as measured by CGM.
Time frame: 8 weeks (after completion of both phases)
% Time in Hyperglycemia (>180 mg/dL)
% time in hyperglycemia (\>180 mg/dL) during the intervention phase in both groups.(i.e. Real-time Dexcom CGM During CGM Intervention vs. Professional Dexcom CGM During Point-of-Care Glucose Intervention), as measured by CGM.
Time frame: 8 weeks (after completion of both phases)
% Time in Hyperglycemia (>250 mg/dl)
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% time in hyperglycemia (\>250 mg/dL) during the intervention phase in both groups.(i.e. Real-time Dexcom CGM During CGM Intervention vs. Professional Dexcom CGM During Point-of-Care Glucose Intervention), as measured by CGM.
Time frame: 8 weeks (after completion of both phases)
Glycemic Variability [% Coefficient of Variation (%CV)
% coefficient of variation will be measured during the intervention phase in both groups.(i.e. Real-time Dexcom CGM During CGM Intervention vs. Professional Dexcom CGM During Point-of-Care Glucose Intervention), as measured by CGM.
Time frame: 8 weeks (after completion of both phases)
Mean Amplitude of Glucose Excursions (MAGE)
Mean amplitude of glucose excursions (MAGE) will be measured during the intervention phase in both groups.(i.e. Real-time Dexcom CGM During CGM Intervention vs. Professional Dexcom CGM During Point-of-Care Glucose Intervention), as measured by CGM.
Time frame: 8 weeks (after completion of both phases)
HbA1C at 3 Months Follow up
HbA1C at 3 months follow up from baseline. Data will be exported from the electronic medical records.
Time frame: Baseline, 3 months post-intervention
Number of Hospitalization or Emergency Room Visits for Hypoglycemia
Rate of hospitalization or emergency room (ER) visits for hypoglycemia will be recorded at baseline (including 1 year prior to the start of the study) and at 3 months post study intervention.
Time frame: Baseline, 3 months post-intervention
Number of Hospitalization or Emergency Room Visits for Diabetes Ketoacidosis (DKA)
Rate of hospitalization or emergency room visits for diabetes ketoacidosis will be recorded at baseline (including 1 year prior to the start of the study) and at 3 months post study intervention.
Time frame: Baseline, 3 months post-intervention