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

NCT02083133 — Completed, 496 participants, Cook County Health

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

Registry	NCT02083133, acronym DOSE-HD
Status	Completed
Study type	Observational
Enrollment	496 (Actual)
Sponsor	Cook County Health (Other gov)
Conditions	Diabetes, Hypoglycemia, Renal Dysfunction, Insulin Dosing
Dates	start 2013-10-01, primary completion 2017-01-15, completion 2017-05-17, first posted 2014-03-11, last updated 2023-06-22
Locations	1 site in United States

-Summary

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.

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+Arms and interventions

Arm	Type	Interventions	Description
End Stage Renal Disease			GFR 15 ml/min or less or on Dialysis
Chronic Kidney Disease Stage 4			GFR 15-30 ml/min
Chronic Kidney Disease Stage -3			GFR 30-60 ml/min

+Outcome measures

Primary outcomes

Hypoglycemia [Last 5 years]

+Eligibility

Sex: All, ages: 18 Years to 99 Years

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

+Locations (1)

Facility	City	Country	Status
John H Stroger Hospital of Cook County	Chicago, Illinois	United States

+Investigators

Pete Antonopoulos, PharmD, Principal investigator, Cook County Hospital