Perioperative Insulin Glargine Dosing Study

Phase 4

Completed

Conditions: Diabetes
Surgery

Interventions: Drug: Lantus
Other: Insulin

Registration Number: NCT00309465

Lead Sponsor: Tamra Dukatz

Brief 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 402

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

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Lantus	Patients in Group 1 will administer 80% of their usual insulin glargine dose.
3	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.
2	Insulin	Group 2 patients will contact their own diabetes care physician and follow those recommendations for the dose.

Primary Outcome Measures

Name	Time	Method
Primary: Preoperative Fasting Blood Sugar Upon Arrival at the Hospital Prior to Surgery	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.

Secondary Outcome Measures