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)

NCT ID: NCT04473430

Last Updated: 2025-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-05
• Study Completion Date: 2023-10-31

Brief 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.

Detailed 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.

Conditions

End-Stage Renal Disease; Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Real-time Dexcom CGM during CGM Intervention

Patients with type 2 DM treated with insulin and receiving hemodialysis will use a real-time/personal CGM for 4 weeks (Intervention-Control Group), then 2 weeks of wash-out period, and cross over to use POC BG for 4 weeks, for insulin adjustments.

Group Type: EXPERIMENTAL

Dexcom Real-time G6 Continuous Glucose Monitoring System (CGM)

Intervention Type: DEVICE

Dexcom G6, a factory-calibrated CGM system, is innovative in many aspects: 1) it does not require finger stick POC BG for calibration, 2) the sensor is small, compact, light-weight, 3) has no interference with several substance and drugs, and 4) protective "urgent low soon" alarm, with proven prediction of hypoglycemia within 20 minutes in advance.

Dexcom G6 monitors glucose continuously (24 hrs) and displays real-time glucose values, glucose trends/arrows and alarms, including the "urgent low soon" alarm (predictive of hypoglycemia < 55 mg/dL within the preceding 20 minutes).

Diagnostic Test: Real-time CGM will be used to collect outcomes variables

Professional Dexcom CGM During Point-Of-Care Blood Glucose Intervention

Patients with type 2 DM treated with insulin and receiving hemodialysis will use POC BG for 4 weeks, then 2 weeks of wash-out period, and cross over to use a real-time/personal CGM for 4 weeks, for insulin adjustments (Control-Intervention Group).

Group Type: EXPERIMENTAL

POC Glucose Testing

Intervention Type: DEVICE

POC BG (standard of care) uses commercially-available glucose meters for blood glucose monitoring. It is approved to be used in dialysis populations.

Diagnostic Test: Professional CGM will be used to collect outcomes variables (including during the POC BG testing).

Interventions

Dexcom Real-time G6 Continuous Glucose Monitoring System (CGM)

Dexcom G6, a factory-calibrated CGM system, is innovative in many aspects: 1) it does not require finger stick POC BG for calibration, 2) the sensor is small, compact, light-weight, 3) has no interference with several substance and drugs, and 4) protective "urgent low soon" alarm, with proven prediction of hypoglycemia within 20 minutes in advance.

Dexcom G6 monitors glucose continuously (24 hrs) and displays real-time glucose values, glucose trends/arrows and alarms, including the "urgent low soon" alarm (predictive of hypoglycemia < 55 mg/dL within the preceding 20 minutes).

Diagnostic Test: Real-time CGM will be used to collect outcomes variables

Intervention Type: DEVICE

POC Glucose Testing

POC BG (standard of care) uses commercially-available glucose meters for blood glucose monitoring. It is approved to be used in dialysis populations.

Diagnostic Test: Professional CGM will be used to collect outcomes variables (including during the POC BG testing).

Intervention Type: DEVICE

Eligibility Criteria

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 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).

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 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Rodolfo Galindo

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guillermo Umpierrez, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory Clinic

Atlanta, Georgia, United States

Grady Health System (non-CRN)

Atlanta, Georgia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

MH121653

Identifier Type: OTHER

Identifier Source: secondary_id

1K23DK123384-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00114840

Identifier Type: -

Identifier Source: org_study_id