Status:
COMPLETED
Perioperative Insulin Glargine Dosing Study
Lead Sponsor:
Tamra Dukatz
Collaborating Sponsors:
Sanofi
Conditions:
Diabetes
Surgery
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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...
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 bot...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
402 Patients enrolled
Trial Details
Trial ID
NCT00309465
Start Date
October 1 2005
End Date
October 1 2009
Last Update
December 3 2012
Active Locations (2)
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1
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
2
William Beaumont Hospital
Troy, Michigan, United States, 48085