Perioperative Insulin Glargine Dosing Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Study of the Relationship Between the Proportional Insulin Glargine Evening Dose and the Perioperative Serum Glucose Values in Patients With Diabetes Undergoing Surgery

Conditions
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Diabetes, Surgery

Intervention / Treatment
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* Drug: Lantus
* Other: Insulin
* Drug: Lantus


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Patients in Group 1 will administer 80% of their usual insulin glargine dose. | Drug: Lantus<br>* Patients in Group 1 will administer 80% of their usual insulin glargine dose.<br>* Other names: Lantus, Insulin;|
| Active Comparator: 2<br>Group 2 patients will contact their own diabetes care physician and follow those recommendations for the dose. | Other: Insulin<br>* Group 2 patients will contact their own diabetes care physician and follow those recommendations for the dose<br>* Other names: As directed by regular physician;|
| Experimental: 3<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Insulin Glargine, Surgery