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)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Emory University
- Enrollment
- 53
- Locations
- 2
- Primary Endpoint
- Differences in Mean Percentage Time-in-hypoglycemia (< 70 mg/dL)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
Arms & Interventions
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).
Intervention: POC Glucose Testing (Device)
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.
Intervention: Dexcom Real-time G6 Continuous Glucose Monitoring System (CGM) (Device)
Outcomes
Primary Outcomes
Differences in Mean Percentage Time-in-hypoglycemia (< 70 mg/dL)
Time Frame: 8 weeks (after completion of both phases)
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).
Secondary Outcomes
- HbA1C at 3 Months Follow up(Baseline, 3 months post-intervention)
- Number of Hospitalization or Emergency Room Visits for Hypoglycemia(Baseline, 3 months post-intervention)
- Number of Hospitalization or Emergency Room Visits for Diabetes Ketoacidosis (DKA)(Baseline, 3 months post-intervention)
- % Time in Target Range (70-180 mg/dl)(8 weeks (after completion of both phases))
- Mean % Time in Hypoglycemia (< 54 mg/dL)(8 weeks (after completion of both phases))
- Glycemic Variability [% Coefficient of Variation (%CV)(8 weeks (after completion of both phases))
- % Time in Hyperglycemia (>250 mg/dl)(8 weeks (after completion of both phases))
- % Time in Hyperglycemia (>180 mg/dL)(8 weeks (after completion of both phases))
- Mean Amplitude of Glucose Excursions (MAGE)(8 weeks (after completion of both phases))
Investigators
Rodolfo Galindo
Principal Investigator
Emory University