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

March 13, 2017 updated by: Karen Carlson, MD, Emory University

The Safety and Efficacy of Correcting Preoperative Hyperglycemia in Ambulatory Surgical Patients With Diabetes: A Randomized Controlled Clinical Trial

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.

Study Overview

Status

Withdrawn

Detailed Description

Investigators plan to randomize a total of 200 male and female subjects with type 1 and type 2 diabetes,having an out patient surgical procedure, meeting inclusion criteria to receive corrective doses of IV regular insulin (Group I) or SC humalog insulin (Group II). The dosing formula is per Emory University Outpatient Surgical Center protocol for treating hyperglycemia and is the same for both groups. All patients with diabetes will undergo a blood sugar measurement upon arrival to the ASC using the Accuchek blood glucose meter. An admission blood sugar of >180 in a patient with diabetes qualifies the patient for study screening. Subjects will be approached after confirmation of eligibility for the study. Randomization, then treatment, will occur immediately following written informed consent. Demographic data will be recorded.A medical history with detailed history of diabetes will be obtained and surgical and anesthesia details and length of stay recorded. Blood sugar levels will be checked hourly until the patient is ready for discharge. Subsequent treatment will follow the hyperglycemia protocol. All blood sugar results and doses of insulin will be recorded. The subject's participation will end at the time of discharge from the Ambulatory Surgical Center.

Study Type

Interventional

Phase

  • Phase 4

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

    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory Healthcare Ambulatory Surgical Center

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 to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female patients between the ages of 18 and 80 years with type 1 and type 2 diabetes
  • patients undergoing ambulatory surgery
  • a known history of diabetes for > 3 months treated with diet, oral antidiabetic agents and/or insulin therapy
  • subjects with an admission/randomization Blood glucose> 180 and < 400 mg/dl
  • Patients willing and able to provide informed consent

Exclusion Criteria:

  • Age < 18 or > 80
  • Subjects with increased blood glucose concentration, but without a history of diabetes (stress hyperglycemia)
  • Patients on an insulin pump
  • Patients with a history of clinically significant hepatic disease (cirrhosis, jaundice, end-stage liver disease, portal hypertension) and end- stage renal disease
  • Current or recent (within 3 months) treatment with oral or injectable corticosteroid, parenteral nutrition and immunosuppressive treatment
  • Mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study
  • Female subjects whom are pregnant or breast-feeding at time of qualifying outpatient procedure

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1-Regular Insulin
Intravenous Regular Insulin will be administered for a preoperative Blood glucose of greater than 180.

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
Other Names:
  • Novolin
Active Comparator: Group 2-Humalog
Subcutaneous Humalog will be administered for a preoperative Blood glucose of greater than 180

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
Other Names:
  • Lispro

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BG concentration differences at 1 and 2 hours post intervention and post operatively
Time Frame: one and two hours post intervention, post operative period
Compare the difference in Blood glucose concentration at one and two hours after the administration of corrective doses of regular and humalog insulin and immediately following ambulatory surgery.
one and two hours post intervention, post operative period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number and percentage of target BG readings
Time Frame: From time of treatment until patient discharge (an average of three hours, less than one day)
Investigators will determine the number and percentage of patients in each group with BG readings within the target range ( 80-180 mg/dl)
From time of treatment until patient discharge (an average of three hours, less than one day)
Episodes of hypoglycemia
Time Frame: time of intervention to time of patient discharge (an average of three hours, less than one day)
Investigators will assess if there is any difference in the number of hypoglycemic events between the two treatment groups and further assess the rate and frequency of hypoglycemia (<70 mg/dl) and severe hypoglycemia (<40 mg/dl).
time of intervention to time of patient discharge (an average of three hours, less than one day)
Episodes of hyperglycemia
Time Frame: time of treatment to time of patient discharge (an average of three hours, less than one day)
Investigators will calculate the number of patients and percent of BG readings with hyperglycemia (>180 mg/dl) and severe hyperglycemia (>300 mg/dl)in each group.
time of treatment to time of patient discharge (an average of three hours, less than one day)
Total dose of insulin
Time Frame: time of intervention to time of patient discharge (an average of three hours, less than one day)
Calculate total dosage of insulin administered to each patient
time of intervention to time of patient discharge (an average of three hours, less than one day)
Change in glucose concentration from baseline to one, two and three hours post treatment
Time Frame: time of baseline BG to time of last BG measurement (prior to discharge, less than one day)
Change in glucose concentration from baseline (prior to insulin administration) to one hour, two hours and three hours (if patient present) after insulin administration
time of baseline BG to time of last BG measurement (prior to discharge, less than one day)
Number of perioperative complications
Time Frame: start of surgery to time of patient discharge (less than one day)
Investigators will record the number of perioperative complications (cardiovascular, respiratory or other medical complications) or need for hospital admission
start of surgery to time of patient discharge (less than one day)

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Carlson Karen, MD, Emory University

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

October 1, 2013

Primary Completion (Anticipated)

September 1, 2018

Study Completion (Anticipated)

September 1, 2018

Study Registration Dates

First Submitted

September 26, 2013

First Submitted That Met QC Criteria

October 22, 2013

First Posted (Estimate)

October 28, 2013

Study Record Updates

Last Update Posted (Actual)

March 15, 2017

Last Update Submitted That Met QC Criteria

March 13, 2017

Last Verified

March 1, 2017

More Information

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.

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