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)

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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End-Stage Renal Disease, Type 2 Diabetes

Intervention / Treatment
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* Device: Dexcom real-time G6 Continuous Glucose Monitoring System (CGM)
* Diagnostic Test: POC BG


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: 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; and vice versa (Control-Intervention Group).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Real-time Dexcom CGM, then Point-Of-Care Blood Glucose Group (Intervention-Control Group)<br>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)<br>* 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).<br>Diagnostic Test: POC BG<br>* POC BG (standard of care) uses commercially-available glucose meters for blood glucose monitoring. It is approved to be used in dialysis populations.<br>|
| Experimental: Point-Of-Care Blood Glucose (Control) then Real-time Dexcom CGM Group (Control-Intervention Group)<br>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)<br>* 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).<br>Diagnostic Test: POC BG<br>* POC BG (standard of care) uses commercially-available glucose meters for blood glucose monitoring. It is approved to be used in dialysis populations.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ESRD, Continuous Glucose Monitoring, Diabetes