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)

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)

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.

Inclusion Criteria:

• adult subjects with type 2 diabetes
• receiving hemodialysis (for at least 90 days)
• treated with insulin therapy [basal insulin alone (glargine U100, glargine U300, detemir, degludec, NPH)], or in combination with bolus insulin (at least one or more injections of aspart, lispro, glulisine, regular insulin) or in combination with incretin therapy (DPPIV or GLP1)
• willingness to wear the CGM
• currently performing self-monitored blood glucose (at least 2 times daily).

Exclusion Criteria:

• use of sulfonylureas or thiazolidinediones alone or in combination with insulin
• use of personal/real-time CGM 3 months prior to study entry (blinded CGM is allowed)
• prior use of insulin pumps or hybrid close loop systems (for at least the prior 28 days)
• current or anticipated use of stress steroids doses (prednisone ≤5mg or its equivalent is allowed)
• subjects who are sensitive or allergic to adhesive
• extensive skin changes/diseases that preclude wearing the required number of devices on normal skin (e.g., extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis) at the proposed wear sites
• any condition that, in the opinion of the Investigator, would interfere with their participation in the trial (e.g., marked visual or hearing impairment, active alcohol or drug abuse, mental illness) or pose excessive risk to study staff handling venous blood samples
• situations that will limit the subject's ability to comply with the protocol (per investigator discretion)
• active malignancy
• unable to give informed consent
• at least 10% of time spent in clinical relevant hypoglycemia (<54 mg/dl) during blinded CGM period
• significant hypoglycemia (< 40 mg/dL)
• severe hyperglycemia (BG> 400 mg/dL)
• extensive skin abnormalities at insertion sites
• pregnancy or breastfeeding
• severe anemia (Hemoglobin < 5 mg/dl)
• polycythemia (Hemoglobin >17 mg/dl)
• subjects taking acetaminophen (more than 1 gr every six hours)
• hydroxyurea (may cause interference with the sensor membrane).