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Perioperative Insulin Glargine Dosing Study

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Tamra Dukatz, William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT00309465
First received: March 30, 2006
Last updated: November 1, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Diabetes
Surgery
 Drug: Lantus
Other: Insulin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study of the Relationship Between the Proportional Insulin Glargine Evening Dose and the Perioperative Serum Glucose Values in Patients With Diabetes Undergoing Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by William Beaumont Hospitals:

Primary Outcome Measures:
  • Primary: Preoperative Fasting Blood Sugar Upon Arrival at the Hospital Prior to Surgery [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 402
Study Start Date: October 2005
Study Completion Date: October 2009
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Lantus, 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 Name: 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
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.
Other Name: Lantus

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00309465

Locations
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
William Beaumont Hospital
Troy, Michigan, United States, 48085
Sponsors and Collaborators
Tamra Dukatz
Sanofi
Investigators
Principal Investigator: Tamra Dukatz, MSN, CRNA William Beaumont Hospitals
  More Information

No publications provided

Responsible Party: Tamra Dukatz, Principal Investigator, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT00309465     History of Changes
Other Study ID Numbers: HIC 2005-080
Study First Received: March 30, 2006
Results First Received: October 1, 2012
Last Updated: November 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by William Beaumont Hospitals:
Diabetes
Insulin Glargine
Surgery

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glargine
 Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013