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Safety and Efficacy Study of Correcting Hyperglycemia in Patients With Diabetes Having Out-patient Surgery

NCT01971047 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2017-03-15

No results posted yet for this study

Summary

The purpose of this study is to compare the safety and efficacy of intravenous (IV) administration of FDA approved regular human insulin and subcutaneous (SC) administration of humalog, a rapid-acting insulin analog (a synthetic insulin), for correction of hyperglycemia (high blood sugar) during the immediate preoperative period in patients with diabetes having outpatient surgery at the Emory Ambulatory Surgical Center (ASC).

In this randomized controlled clinical trial patients with diabetes will be administered corrective doses of IV regular insulin or SC humalog for preoperative hyperglycemia to determine whether SC humalog results in improved intra and post-operative blood sugar control.The most common current practice at Emory University in the ambulatory surgical setting is IV administration of regular insulin for treatment of pre-operative hyperglycemia. Subjects will not be paid for their participation and will be assured of treatment for their hyperglycemia regardless of study participation.

Conditions

Interventions

DRUG

Regular Insulin

Group 1 Treatment Arm,Follow dosing for BG \>180 per the following formula: 1. Patients with Type 2 Diabetes to receive dosage based on the formula: (BG-120)/30= # units of insulin 2. Patients with Type 1 Diabetes to receive dosage based on the formula: (BG-120)/40=# units of insulin 3. Patients with Type 1 Diabetes and Type 2 Diabetes over the age of 70 or with chronic kidney disease to receive dosage based on the formula: (BG-120)/50=# units of insulin 4. Consider repeating dose if BG\>240 mg/dl after 2 hours of initial dose

DRUG

Humalog

Group 2 treatment arm. Follow dosing for Blood glucose \> 180, per the following formula: 1. Patients with Type 2 Diabetes to receive dosage based on the formula: (BG-120)/30= # units of insulin 2. Patients with Type 1 Diabetes to receive dosage based on the formula: (BG-120)/40=# units of insulin 3. Patients with Type 1 Diabetes and Type 2 Diabetes over the age of 70 or with chronic kidney disease to receive dosage based on the formula: (BG-120)/50=# units of insulin 4. Consider repeating dose if BG\>240 mg/dl after 2 hours of initial dose

Sponsors & Collaborators

  • Emory University

    lead OTHER

Principal Investigators

  • Carlson Karen, MD · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2018-09-30
Completion
2018-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01971047 on ClinicalTrials.gov