Clareo Health | 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)
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Keep this study
Lead
Emory University
With
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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.
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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).
You may not be if
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).
