Perioperative Insulin Glargine Dosing Study

Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00309465
• Other study ID #: HIC 2005-080
• Status: Completed
• Phase: Phase 4
• First received: March 30, 2006
• Last updated: November 1, 2012
• Start date: October 2005
• Est. completion date: October 2009

Study information

• Verified date: November 2012
• Source: William Beaumont Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 402
• Est. completion date: October 2009
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Surgery

Intervention

Drug:
• Lantus
Patients in Group 1 will administer 80% of their usual insulin glargine dose.

Other:
• Insulin
Group 2 patients will contact their own diabetes care physician and follow those recommendations for the dose

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.

Locations

Country	Name	City	State
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	William Beaumont Hospital	Troy	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Tamra Dukatz	Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary: Preoperative Fasting Blood Sugar Upon Arrival at the Hospital Prior to Surgery	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	Yes