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)

Type 2 Diabetes Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04473430
• Other study ID #: IRB00114840
• Secondary ID: MH1216531K23DK12
• Status: Completed
• Phase: N/A
• Start date: November 5, 2020
• Est. completion date: October 31, 2023

Study information

• Verified date: December 2023
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: October 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• End-Stage Renal Disease
• Hypoglycemia
• Kidney Failure, Chronic
• Type 2 Diabetes

Intervention

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.

Locations

Country	Name	City	State
United States	Emory Clinic	Atlanta	Georgia
United States	Grady Health System (non-CRN)	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	% 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
Secondary	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
Secondary	% 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
Secondary	% 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
Secondary	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
Secondary	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
Secondary	Change in HbA1C at 3 months follow up	Change in HbA1C at 3 months follow up from baseline	Baseline, Up to 3 months
Secondary	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
Secondary	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