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Completed

NCT Number: NCT00309465

Perioperative Insulin Glargine Dosing Study

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

William Beaumont Hospital, Royal Oak, Michigan, United States

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About this study

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.

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lantus

Drug

Patients in Group 1 will administer 80% of their usual insulin glargine dose.

Other names: Lantus, Insulin

Insulin

Other

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

Other names: As directed by regular physician

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Tamra Dukatz

Other

Collaborators

  • Sanofi

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2008
Study completion
2009
First posted
Mar 31, 2006
Registry last updated
Dec 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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