Perioperative Insulin Glargine Dosing Study

November 1, 2012 updated by: Tamra Dukatz

A Study of the Relationship Between the Proportional Insulin Glargine Evening Dose and the Perioperative Serum Glucose Values in Patients With Diabetes Undergoing Surgery

The main objective of this study is to compare three strategies of evening insulin glargine dosing to preoperative glucose values in patients with diabetes undergoing surgery to determine which dosing strategies most often achieves the admission target study values of 100-179 mg/dl.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

There are no evidence-based guidelines for insulin glargine (Lantus) dosing in the perioperative setting. Insulin glargine provides peakless 24-hour coverage of basal insulin needs for people with both Type 1 and Type 2 diabetes. Insulin glargine may be used as the sole insulin or in combination with other rapid-acting insulin to achieve glycemic control.

Anesthesia literature recommends that blood sugar values on insulin-dependent patients be maintained between 120-180 mg/dl in most surgeries. Symptoms of low blood sugar are undetectable in anesthetized patients, and blood glucose is tested at least hourly. Since patients are still awake and alert toward hypoglycemic symptoms in the preoperative area, the admission target study values are 100-179 mg/dl. Glucose values greater than 200 mg/dl have been associated with increased rates of infection, and exacerbated complications if a major cardiovascular event happens.

Frequently insulin glargine is administered in the evening. Patients who are scheduled for surgery in the morning are asked not to eat or drink after midnight. Some endocrinology experts recommend that all or part of the patient's usual insulin glargine should be given to avoid high blood sugar; however, whenever insulin is given without food, the possibility of low blood sugar exists.

  1. Patients in Group 1 will administer 80% of their usual insulin glargine dose.
  2. Group 2 patients will contact their own diabetes care physician and follow those recommendations for the dose.
  3. Group 3 patients will take 50%, 80%, or 100% of their usual insulin glargine dose. Which of those three percentages will be determined by the midpoint of the patient's usual self-reported fasting blood sugar (FBS) range and whether the patients is also taking a rapid-acting insulin.

Study Type

Interventional

Enrollment (Actual)

402

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

  • United States
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Hospital
      • Troy, Michigan, United States, 48085
        • William Beaumont Hospital

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

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Scheduled for Surgical Procedure
  • Self Management of Diabetes
  • Currently on Evening Insulin Glargine prescribed by Primary Care Physician
  • Age 18 or over
  • Able to Communicate Clearly over the Phone
  • Pre-screened by Anesthesia Department > 48 hours prior to Surgery

Exclusion Criteria:

  • On Glucocorticoid Medication
  • On Insulin Glargine Dual Dosing or Sliding Scale Regimen
  • History of Hypoglycemia Unawareness
  • Pregnancy or Lactating Female
  • On Insulin Glargine for < 3 months

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
Experimental: 1
Patients in Group 1 will administer 80% of their usual insulin glargine dose.
Drug: Lantus
Patients in Group 1 will administer 80% of their usual insulin glargine dose.
Other Names:
  • Lantus, Insulin
Drug: Lantus
Group 3 patients will take 50%, 80%, or 100% of their usual insulin glargine dose. Which of those three percentages will be determined by the midpoint of the patient's usual self-reported fasting blood sugar (FBS) range and whether the patients is also taking a rapid-acting insulin.
Active Comparator: 2
Group 2 patients will contact their own diabetes care physician and follow those recommendations for the dose.
Other: Insulin
Group 2 patients will contact their own diabetes care physician and follow those recommendations for the dose
Other Names:
  • As directed by regular physician
Experimental: 3
Group 3 patients will take 50%, 80%, or 100% of their usual insulin glargine dose. Which of those three percentages will be determined by the midpoint of the patient's usual self-reported fasting blood sugar (FBS) range and whether the patients is also taking a rapid-acting insulin.
Drug: Lantus
Patients in Group 1 will administer 80% of their usual insulin glargine dose.
Other Names:
  • Lantus, Insulin
Drug: Lantus
Group 3 patients will take 50%, 80%, or 100% of their usual insulin glargine dose. Which of those three percentages will be determined by the midpoint of the patient's usual self-reported fasting blood sugar (FBS) range and whether the patients is also taking a rapid-acting insulin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary: Preoperative Fasting Blood Sugar Upon Arrival at the Hospital Prior to Surgery
Time Frame: Day 1
Venous blood glucose values were obtained in the preoperative nursing unit. Blood glucose values were analyzed for achievement of target 100-179 mg/dl range and extended 80-249 mg/dl range. Analyses were by intention to treat.
Day 1

Collaborators and Investigators

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

Sponsor

Tamra Dukatz

Collaborators

Sanofi

Investigators

  • Principal Investigator: Tamra Dukatz, MSN, CRNA, William Beaumont Hospitals

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, 2005

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

March 30, 2006

First Submitted That Met QC Criteria

March 30, 2006

First Posted (Estimate)

March 31, 2006

Study Record Updates

Last Update Posted (Estimate)

December 3, 2012

Last Update Submitted That Met QC Criteria

November 1, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HIC 2005-080

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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