Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • End Stage Renal Disease
  • Type 2 Diabetes
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: Patients with type 2 DM treated with insulin, with prior hypoglycemic episodes, and on 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 (Outcomes Assessor)Primary Purpose: Diagnostic

Participation Requirements

Age
Between 18 years and 80 years
Gender
Both males and females

Description

The study is conducted to examine the prevalence of hypoglycemia, hyperglycemia and estimate glycemic variability patterns among patients with type 2 diabetes (DM2), treated with insulin and receiving hemodialysis, to assess the accuracy of the CGM in this specific cohort, and to assess the efficacy...

The study is conducted to examine the prevalence of hypoglycemia, hyperglycemia and estimate glycemic variability patterns among patients with type 2 diabetes (DM2), treated with insulin and receiving hemodialysis, to assess the accuracy of the CGM in this specific cohort, and to assess the efficacy of real-time CGM data in preventing hypoglycemia and hyperglycemia. 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.

Tracking Information

NCT #
NCT04473430
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Rodolfo Galindo, MD Emory University