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

June 16, 2023 updated by: Pete Antonopoulos, Cook County Health

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

496

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • John H Stroger Hospital of Cook County

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

In patient hospitalized greater than or equal to three days, diabetic with CKD 3-5 or on dialysis on insulin therapy

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hypoglycemia
Time Frame: Last 5 years
Last 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cook County Health

Investigators

  • Principal Investigator: Pete Antonopoulos, PharmD, Cook County Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2013

Primary Completion (Actual)

January 15, 2017

Study Completion (Actual)

May 17, 2017

Study Registration Dates

First Submitted

March 7, 2014

First Submitted That Met QC Criteria

March 7, 2014

First Posted (Estimated)

March 11, 2014

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 16, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-188

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypoglycemia

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cyprus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe