Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE4
402 participants
INTERVENTIONAL
2005-10-31
2009-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Patients in Group 1 will administer 80% of their usual insulin glargine dose.
Lantus
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.
Insulin
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.
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.
Interventions
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Lantus
Patients in Group 1 will administer 80% of their usual insulin glargine dose.
Insulin
Group 2 patients will contact their own diabetes care physician and follow those recommendations for the dose
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Insulin Glargine Dual Dosing or Sliding Scale Regimen
* History of Hypoglycemia Unawareness
* Pregnancy or Lactating Female
* On Insulin Glargine for \< 3 months
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Tamra Dukatz
OTHER
Responsible Party
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Tamra Dukatz
Principal Investigator
Principal Investigators
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Tamra Dukatz, MSN, CRNA
Role: PRINCIPAL_INVESTIGATOR
William Beaumont Hospitals
Locations
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William Beaumont Hospital
Royal Oak, Michigan, United States
William Beaumont Hospital
Troy, Michigan, United States
Countries
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Other Identifiers
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HIC 2005-080
Identifier Type: -
Identifier Source: org_study_id