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); Diagnostic test: POC BG

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): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rodolfo Galindo, MD; Phone Number: 404-251-8957; Email: rodolfo.galindo@emory.edu

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, 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 (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, then Point-Of-Care Blood Glucose Group (Intervention-Control Group); 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.	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. The sensor uses a novel semi-permeable membrane that blocks interference with most clinically relevant substances, including high levels of urea and creatinine, and commonly used medications. Dexcom G6 CGM is a commercially-available, minimally invasive sensor, with a flexible and thin wire that is inserted into the abdominal subcutaneous tissue. 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: POC BG; POC BG (standard of care) uses commercially-available glucose meters for blood glucose monitoring. It is approved to be used in dialysis populations.
Experimental: Point-Of-Care Blood Glucose (Control) then Real-time Dexcom CGM Group (Control-Intervention Group); 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 (Control-Intervention Group).	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. The sensor uses a novel semi-permeable membrane that blocks interference with most clinically relevant substances, including high levels of urea and creatinine, and commonly used medications. Dexcom G6 CGM is a commercially-available, minimally invasive sensor, with a flexible and thin wire that is inserted into the abdominal subcutaneous tissue. 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: POC BG; POC BG (standard of care) uses commercially-available glucose meters for blood glucose monitoring. It is approved to be used in dialysis populations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences in mean percentage time-in-hypoglycemia (< 70 mg/dL) during the intervention phase, compared to control in both phases (i.e. intervention-control vs. control-intervention).	Differences in mean percentage time-in-hypoglycemia (< 70 mg/dL) during the intervention phase, compared to control in both phases (i.e. intervention-control vs. control-intervention).	Up to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
% time in target range (70-180 mg/dl) during the intervention phase, compared to control in both groups (i.e. intervention-control vs. control-intervention)	% time in target range (70-180 mg/dl) during the intervention phase, compared to control in both groups (i.e. intervention-control vs. control-intervention)	Up to 3 months
Mean % time in hypoglycemia (< 54 mg/dL)	% time in hypoglycemia (<54 mg/dL) during the intervention phase, compared to control in both groups (i.e. intervention-control vs. controlintervention).	Up to 3 months
% time in hyperglycemia (>180 mg/dL)	% time in hyperglycemia (>180 mg/dL) during the intervention phase, compared to control in both groups (i.e. intervention-control vs. controlintervention).	Up to 3 months
% time in hyperglycemia (>250 mg/dl)	% time in hyperglycemia (>250 mg/dL) during the intervention phase, compared to control in both groups	Up to 3 months
Glycemic variability [% coefficient of variation (%CV)	% coefficient of variation will be measured during the intervention phase, compared to control in both groups (i.e. intervention-control vs. contro-intervention).	Up to 3 months
Mean amplitude of glucose excursions (MAGE)	Mean amplitude of glucose excursions (MAGE) will be measured during the intervention phase, compared to control in both groups (i.e. intervention-control vs. control-intervention).	Up to 3 months
Change in HbA1C at 3 months follow up	Change in HbA1C at 3 months follow up from baseline	Baseline, Up to 3 months
Number of hospitalization or emergency room visits for hypoglycemia	Rate of hospitalization or emergency room visits for hypoglycemia will be recorded	Up to 3 months
Number of hospitalization or emergency room visits for diabetes ketoacidosis	Rate of hospitalization or emergency room visits for diabetes ketoacidosis will be recorded	Up to 3 months

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 (Estimated): December 6, 2023
• Last Update Submitted That Met QC Criteria: December 5, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Diabetes; Continuous Glucose Monitoring; ESRD
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Kidney Diseases; Urologic Diseases; Disease Attributes; Renal Insufficiency; Renal Insufficiency, Chronic; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Failure, Chronic; Hypoglycemia
• 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