Phase
Condition
Diabetes (Pediatric)
Diabetes Mellitus Types I And Ii
Hormone Deficiencies
Treatment
Dexcom real-time G6 Continuous Glucose Monitoring System (CGM)
POC Glucose Testing
POC BG
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 moreinjections of aspart, lispro, glulisine, regular insulin) or in combination withincretin therapy (DPPIV or GLP1)
willingness to wear the CGM
currently performing self-monitored blood glucose (at least 2 times daily).
Exclusion
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 28days)
current or anticipated use of stress steroids doses (prednisone ≤5mg or itsequivalent is allowed)
subjects who are sensitive or allergic to adhesive
extensive skin changes/diseases that preclude wearing the required number of deviceson normal skin (e.g., extensive psoriasis, recent burns or severe sunburn, extensiveeczema, extensive scarring, extensive tattoos, dermatitis herpetiformis) at theproposed wear sites
any condition that, in the opinion of the Investigator, would interfere with theirparticipation in the trial (e.g., marked visual or hearing impairment, activealcohol or drug abuse, mental illness) or pose excessive risk to study staffhandling venous blood samples
situations that will limit the subject's ability to comply with the protocol (perinvestigator discretion)
active malignancy
unable to give informed consent
at least 10% of time spent in clinical relevant hypoglycemia (<54 mg/dl) duringblinded 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).
Study Design
Study Description
Connect with a study center
Emory Clinic
Atlanta, Georgia 30322
United StatesSite Not Available
Grady Health System (non-CRN)
Atlanta, Georgia 30322
United StatesSite Not Available
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