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)

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes; End-Stage Renal Disease
• Intervention / Treatment: Device: Dexcom Real-time G6 Continuous Glucose Monitoring System (CGM); Device: POC Glucose Testing

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.

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory Clinic
    • Atlanta, Georgia, United States, 30322
      • Grady Health System (non-CRN)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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
Experimental: 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).	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences in Mean Percentage Time-in-hypoglycemia (< 70 mg/dL)	Differences in mean percentage time-in-hypoglycemia (< 70 mg/dL) during the intervention phase in both groups (i.e. Real-time Dexcom CGM During CGM Intervention vs. Professional Dexcom CGM During Point-of-Care Glucose Intervention), as measured by CGM. Participants will use either CGM or POC BG testing (during each assignment phase) for insulin adjustment. CGM will be used to collect outcomes variables during each phase (including during the POC BG testing).	8 weeks (after completion of both phases)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
% Time in Target Range (70-180 mg/dl)	% time in target range (70-180 mg/dl) during the intervention phase in both groups (i.e. Real-time Dexcom CGM During CGM Intervention vs. Professional Dexcom CGM During Point-of-Care Glucose Intervention), as measured by CGM. Participants will use either CGM or POC BG testing (during each assignment phase) for insulin adjustment. CGM will be used to collect outcomes variables during each phase (including during the POC BG testing).	8 weeks (after completion of both phases)
Mean % Time in Hypoglycemia (< 54 mg/dL)	% time in hypoglycemia (<54 mg/dL) during the intervention phase in both groups (i.e. Real-time Dexcom CGM During CGM Intervention vs. Professional Dexcom CGM During Point-of-Care Glucose Intervention), as measured by CGM.	8 weeks (after completion of both phases)
% Time in Hyperglycemia (>180 mg/dL)	% time in hyperglycemia (>180 mg/dL) during the intervention phase in both groups.(i.e. Real-time Dexcom CGM During CGM Intervention vs. Professional Dexcom CGM During Point-of-Care Glucose Intervention), as measured by CGM.	8 weeks (after completion of both phases)
% Time in Hyperglycemia (>250 mg/dl)	% time in hyperglycemia (>250 mg/dL) during the intervention phase in both groups.(i.e. Real-time Dexcom CGM During CGM Intervention vs. Professional Dexcom CGM During Point-of-Care Glucose Intervention), as measured by CGM.	8 weeks (after completion of both phases)
Glycemic Variability [% Coefficient of Variation (%CV)	% coefficient of variation will be measured during the intervention phase in both groups.(i.e. Real-time Dexcom CGM During CGM Intervention vs. Professional Dexcom CGM During Point-of-Care Glucose Intervention), as measured by CGM.	8 weeks (after completion of both phases)
Mean Amplitude of Glucose Excursions (MAGE)	Mean amplitude of glucose excursions (MAGE) will be measured during the intervention phase in both groups.(i.e. Real-time Dexcom CGM During CGM Intervention vs. Professional Dexcom CGM During Point-of-Care Glucose Intervention), as measured by CGM.	8 weeks (after completion of both phases)
HbA1C at 3 Months Follow up	HbA1C at 3 months follow up from baseline. Data will be exported from the electronic medical records.	Baseline, 3 months post-intervention
Number of Hospitalization or Emergency Room Visits for Hypoglycemia	Rate of hospitalization or emergency room (ER) visits for hypoglycemia will be recorded at baseline (including 1 year prior to the start of the study) and at 3 months post study intervention.	Baseline, 3 months post-intervention
Number of Hospitalization or Emergency Room Visits for Diabetes Ketoacidosis (DKA)	Rate of hospitalization or emergency room visits for diabetes ketoacidosis will be recorded at baseline (including 1 year prior to the start of the study) and at 3 months post study intervention.	Baseline, 3 months post-intervention

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Guillermo Umpierrez, MD, Emory University

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2020
• Primary Completion (Actual): October 31, 2023
• Study Completion (Actual): October 31, 2023

Study Registration Dates

• First Submitted: July 13, 2020
• First Submitted That Met QC Criteria: July 13, 2020
• First Posted (Actual): July 16, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 17, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Diabetes; Continuous Glucose Monitoring; ESRD
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Metabolic Diseases; Glucose Metabolism Disorders; Renal Insufficiency; Renal Insufficiency, Chronic; Hypoglycemia; Kidney Failure, Chronic
• Other Study ID Numbers: IRB00114840; MH121653 (Other Identifier: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)); 1K23DK123384-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared
• IPD Sharing Time Frame: Start 6 months after publication End 12 months after publication

IPD Sharing Access Criteria

Researchers who provide a methodologically sound proposal to achieve the aims in the approved proposal will get access. Proposals should be directed to rodolfo.galindo@emory.edu.

To gain access, data requestors will need to sign a data access agreement.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No