Clinical trial NCT04473430: 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)
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End-Stage Renal Disease
Type 2 Diabetes
Keywords: ESRD
Continuous Glucose Monitoring
Diabetes
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2020-07-16
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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).
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Differences in Mean Percentage Time-in-hypoglycemia (< 70 mg/dL)
timeFrame: 8 weeks (after completion of both phases)
Secondary outcomes:
measure: % Time in Target Range (70-180 mg/dl)
timeFrame: 8 weeks (after completion of both phases)
measure: Mean % Time in Hypoglycemia (< 54 mg/dL)
timeFrame: 8 weeks (after completion of both phases)
measure: % Time in Hyperglycemia (>180 mg/dL)
timeFrame: 8 weeks (after completion of both phases)
measure: % Time in Hyperglycemia (>250 mg/dl)
timeFrame: 8 weeks (after completion of both phases)
measure: Glycemic Variability [% Coefficient of Variation (%CV)
timeFrame: 8 weeks (after completion of both phases)
measure: Mean Amplitude of Glucose Excursions (MAGE)
timeFrame: 8 weeks (after completion of both phases)
measure: HbA1C at 3 Months Follow up
timeFrame: Baseline, 3 months post-intervention
measure: Number of Hospitalization or Emergency Room Visits for Hypoglycemia
timeFrame: Baseline, 3 months post-intervention
measure: Number of Hospitalization or Emergency Room Visits for Diabetes Ketoacidosis (DKA)
timeFrame: Baseline, 3 months post-intervention
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Clinic
state: Georgia
city: Atlanta
country: United States
facility: Grady Health System (non-CRN)
state: Georgia
Study officials:
affiliation: Emory University
name: Guillermo Umpierrez, MD
role: PRINCIPAL_INVESTIGATOR
References: