Use of Continuous Glucose Monitoring (CGM) in End-Stage Renal Disease (ESRD) Patients With Type 2 Diabetes

  • STATUS
    Recruiting
  • End date
    Oct 18, 2023
  • participants needed
    45
  • sponsor
    Emory University
Updated on 18 March 2022
insulin
hyperglycemia
hemoglobin a1c
finger stick
hypoglycemia
sitagliptin
hypoglycemic agents
continuous glucose monitoring

Summary

The study is conducted to assess the efficacy of real-time CGM data in preventing hypoglycemia and hyperglycemia in patients with type 2 diabetes and end-stage kidney disease (ESKD), treated with insulin therapy and receiving hemodialysis.

Description

The study is conducted to assess the efficacy of real-time CGM data in preventing hypoglycemia and hyperglycemia 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.

Details
Condition End-Stage Renal Disease, Type 2 Diabetes
Treatment Dexcom G6 CGM, POC BG
Clinical Study IdentifierNCT04473430
SponsorEmory University
Last Modified on18 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Inclusion criteria
receiving hemodialysis (for at least 90 days)
adult subjects with type 2 diabetes
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

current or anticipated use of stress steroids doses (prednisone ≤5mg or its equivalent is allowed)
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)
at least 10% of time spent in clinical relevant hypoglycemia (<54 mg/dl) during blinded CGM period
significant hypoglycemia (< 40 mg/dL)
extensive skin abnormalities at insertion sites
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