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Perioperative Insulin Glargine Dosing Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00309465
First Posted: March 31, 2006
Last Update Posted: December 3, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Sanofi
Information provided by (Responsible Party):
Tamra Dukatz, William Beaumont Hospitals
March 30, 2006
March 31, 2006
October 1, 2012
December 3, 2012
December 3, 2012
October 2005
October 2008   (Final data collection date for primary outcome measure)
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.
Primary: Preoperative Fasting Blood Sugar Upon Arrival at the Hospital Prior to Surgery
Complete list of historical versions of study NCT00309465 on ClinicalTrials.gov Archive Site
Not Provided
Secondary:
Not Provided
Not Provided
 
Perioperative Insulin Glargine Dosing Study
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.

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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Diabetes
  • Surgery
  • Drug: Lantus
    Patients in Group 1 will administer 80% of their usual insulin glargine dose.
    Other Name: Lantus, Insulin
  • Other: Insulin
    Group 2 patients will contact their own diabetes care physician and follow those recommendations for the dose
    Other Name: As directed by regular physician
  • 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.
  • Experimental: 1
    Patients in Group 1 will administer 80% of their usual insulin glargine dose.
    Intervention: Drug: Lantus
  • Active Comparator: 2
    Group 2 patients will contact their own diabetes care physician and follow those recommendations for the dose.
    Intervention: Other: Insulin
  • 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.
    Intervention: Drug: Lantus
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
402
October 2009
October 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00309465
HIC 2005-080
No
Not Provided
Not Provided
Tamra Dukatz, William Beaumont Hospitals
Tamra Dukatz
Sanofi
Principal Investigator: Tamra Dukatz, MSN, CRNA William Beaumont Hospitals
William Beaumont Hospitals
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP