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)

Not Applicable

Completed

• Conditions: Type 2 Diabetes; End-Stage Renal Disease
• Interventions: Device: Dexcom real-time G6 Continuous Glucose Monitoring System (CGM); Diagnostic Test: POC BG

• Registration Number: NCT04473430
• Lead Sponsor: Emory University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-07-13
• Study First Submitted QC: 2020-07-13
• Study First Posted: 2020-07-16
• Study Start: 2020-11-05
• Primary Completion: 2023-10-31
• Study Completion: 2023-10-31
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-05
• Last Update Posted: 2023-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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).

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Point-Of-Care Blood Glucose (Control) then Real-time Dexcom CGM Group (Control-Intervention Group)	Dexcom real-time G6 Continuous Glucose Monitoring System (CGM)	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).
Point-Of-Care Blood Glucose (Control) then Real-time Dexcom CGM Group (Control-Intervention Group)	POC BG	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).
Real-time Dexcom CGM, then Point-Of-Care Blood Glucose Group (Intervention-Control Group)	Dexcom real-time G6 Continuous Glucose Monitoring System (CGM)	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.
Real-time Dexcom CGM, then Point-Of-Care Blood Glucose Group (Intervention-Control Group)	POC BG	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.

Primary Outcome Measures

Name	Time	Method
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	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).

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Emory Clinic; 🇺🇸 Atlanta, Georgia, United States

Grady Health System (non-CRN); 🇺🇸 Atlanta, Georgia, United States