Insulin Dosing in Diabetic Patients With End Stage Renal Disease (ESRD) or Hemodialysis (DOSE-HD)

Cook County Health

Status: Completed

Conditions: Hypoglycemia; Insulin Dosing; Diabetes; Renal Dysfunction

Study type: Observational

Funder types: Other

Identifiers

NCT02083133

13-188

Details and patient eligibility

About

The purpose of this study is to assess whether the current recommendation for a 50% dose reduction in insulin for diabetic patients with a creatinine clearance (CrCl) ≤15 mL/min or on hemodialysis results in an increased number of hypoglycemic episodes.

Enrollment: 496 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Inpatient men and women 18 years of age and older with a diagnosis of type 2 diabetes mellitus (T2DM) with CrCl ≥60, 16-59 or ≤15 milliliters/minute.

Exclusion criteria

• Patients less than 18 years of age, pregnant patients

Trial design

496 participants in 3 patient groups

End Stage Renal Disease

Description:

GFR 15 ml/min or less or on Dialysis

Chronic Kidney Disease Stage 4

Description:

GFR 15-30 ml/min

Chronic Kidney Disease Stage -3

Description:

GFR 30-60 ml/min