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

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ClinicalTrials.gov Identifier: NCT02083133
Recruitment Status : Unknown
Verified March 2014 by Pete Antonopoulos, John H. Stroger Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : March 11, 2014
Last Update Posted : March 11, 2014
Sponsor:
Information provided by (Responsible Party):
Pete Antonopoulos, John H. Stroger Hospital

Brief 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.

Condition or disease
Diabetes Hypoglycemia Renal Dysfunction Insulin Dosing

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Study Type : Observational
Actual Enrollment : 496 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Dosing Strategies in Diabetic Patients With End Stage Renal Disease (ESRD) or Hemodialysis (DOSE-HD Study)
Study Start Date : October 2013
Estimated Primary Completion Date : October 2014
Estimated Study Completion Date : October 2014

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Hypoglycemia [ Time Frame: Last 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02083133


Locations
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United States, Illinois
John H Stroger Hospital of Cook County
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
John H. Stroger Hospital
Investigators
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Principal Investigator: Pete Antonopoulos, PharmD Cook County Hospital
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Responsible Party: Pete Antonopoulos, Clinical Pharmacist- Principal Investigator, John H. Stroger Hospital
ClinicalTrials.gov Identifier: NCT02083133    
Other Study ID Numbers: 13-188
First Posted: March 11, 2014    Key Record Dates
Last Update Posted: March 11, 2014
Last Verified: March 2014
Keywords provided by Pete Antonopoulos, John H. Stroger Hospital:
Diabetes
Renal Failure
Dialysis
End Stage Renal Disease
Hypoglycemia
Additional relevant MeSH terms:
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Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency
Hypoglycemia
Urologic Diseases
Renal Insufficiency, Chronic
Glucose Metabolism Disorders
Metabolic Diseases