Insulin Dosing in Diabetic Patients With End Stage Renal... | NCT02083133

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

NCT02083133

Sponsor

Cook County Health

Status

Completed

Last Update Posted

Jun 22, 2023Actual

Enrollment

496Actual

Phase

Not provided

Conditions

Diabetes
Hypoglycemia
Renal Dysfunction
Insulin Dosing

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2013Actual

Primary Completion Date

Jan 15, 2017Actual

Completion Date

May 17, 2017Actual

First Submitted Date

Mar 7, 2014

First Submission Date that Met QC Criteria

Mar 7, 2014

First Posted Date

Mar 11, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 16, 2023

Last Update Posted Date

Jun 22, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Pete Antonopoulos, Clinical Pharmacist- Principal Investigator, Cook County HealthPrincipal Investigator

Lead Sponsor

Cook County HealthOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

496Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Measure	Description	Time Frame
Hypoglycemia		Last 5 years

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pete Antonopoulos, PharmD	Cook County Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
John H Stroger Hospital of Cook County		Chicago	Illinois	60612	United States

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus
D007003	Hypoglycemia
D051437	Renal Insufficiency
D007676	Kidney Failure, Chronic

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided