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)

Last updated: January 17, 2025
Sponsor: Emory University
Overall Status: Completed

Phase

N/A

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

NCT04473430
IRB00114840
1K23DK123384-01
MH121653
  • Ages 18-80
  • All Genders

Study Summary

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.

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

Total Participants: 53
Treatment Group(s): 4
Primary Treatment: Dexcom real-time G6 Continuous Glucose Monitoring System (CGM)
Phase:
Study Start date:
November 05, 2020
Estimated Completion Date:
October 31, 2023

Study Description

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.

Connect with a study center

  • Emory Clinic

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Grady Health System (non-CRN)

    Atlanta, Georgia 30322
    United States

    Site Not Available

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