Use of Continuous Glucose Monitoring (CGM) in End-Stage Renal Disease (ESRD) Patients With Type 2 Diabetes
Use of Continuous Glucose Monitoring (CGM) in End-Stage Renal Disease (ESRD) Patients With Type 2 Diabetes
The study is conducted to examine the prevalence of hypoglycemia, hyperglycemia and estimate
 glycemic variability patterns among patients with type 2 diabetes (DM2), treated with insulin
 and receiving hemodialysis, to assess the accuracy of the CGM in this specific cohort, and to
 assess the efficacy of real-time CGM data in preventing hypoglycemia and hyperglycemia.
The study is conducted to examine the prevalence of hypoglycemia, hyperglycemia and estimate
 glycemic variability patterns among patients with type 2 diabetes (DM2), treated with insulin
 and receiving hemodialysis, to assess the accuracy of the CGM in this specific cohort, and to
 assess the efficacy of real-time CGM data in preventing hypoglycemia and hyperglycemia.

 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:

 Inclusion Criteria Aim 1a/b:

 -  Ambulatory patients with type 2 diabetes

 -  18-80 years of age

 -  willing to perform at least 4-8 self-monitored blood glucose (SMBG) tests at home

 -  HbA1c 5-12%

 -  eGFR < 15 mL/min/1.73m2

 -  receiving dialysis (hemodialysis) for at least 3 months

 -  on insulin therapy [basal insulin alone (glargine U100, glargine U300, determir,
 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
 (sitagliptin, linagliptin).

 Inclusion criteria Aim 2a:

 -  adult subjects with type 2 diabetes

 -  receiving hemodialysis at the Emory Dialysis Center or Grady Dialysis Unit (for at
 least 90 days)

 -  treated with insulin therapy [basal insulin alone (glargine U100, glargine U300,
 determir, 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 (sitagliptin, linagliptin)

 -  willingness to wear the CGM

 -  currently performing self-monitored blood glucose (at least 2 times daily).

 Exclusion Criteria:

 Exclusion Criteria Aim 1a/b:

 -  critical medical or surgical illness, active malignancy with ongoing therapy

 -  unable to give informed consent

 -  severe hypoglycemia (BG < 40 mg/dL)

 -  severe hyperglycemia (BG> 400 mg/dL)

 -  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)

 -  taking secretagogues (glipizide, glyburide, glimepiride, repaglinide)

 -  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.

 Exclusion criteria Aim 2a:

 -  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).