- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01971047
Safety and Efficacy Study of Correcting Hyperglycemia in Patients With Diabetes Having Out-patient Surgery
The Safety and Efficacy of Correcting Preoperative Hyperglycemia in Ambulatory Surgical Patients With Diabetes: A Randomized Controlled Clinical Trial
The purpose of this study is to compare the safety and efficacy of intravenous (IV) administration of FDA approved regular human insulin and subcutaneous (SC) administration of humalog, a rapid-acting insulin analog (a synthetic insulin), for correction of hyperglycemia (high blood sugar) during the immediate preoperative period in patients with diabetes having outpatient surgery at the Emory Ambulatory Surgical Center (ASC).
In this randomized controlled clinical trial patients with diabetes will be administered corrective doses of IV regular insulin or SC humalog for preoperative hyperglycemia to determine whether SC humalog results in improved intra and post-operative blood sugar control.The most common current practice at Emory University in the ambulatory surgical setting is IV administration of regular insulin for treatment of pre-operative hyperglycemia. Subjects will not be paid for their participation and will be assured of treatment for their hyperglycemia regardless of study participation.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Georgia
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Atlanta, Georgia, United States, 30322
- Emory Healthcare Ambulatory Surgical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male or female patients between the ages of 18 and 80 years with type 1 and type 2 diabetes
- patients undergoing ambulatory surgery
- a known history of diabetes for > 3 months treated with diet, oral antidiabetic agents and/or insulin therapy
- subjects with an admission/randomization Blood glucose> 180 and < 400 mg/dl
- Patients willing and able to provide informed consent
Exclusion Criteria:
- Age < 18 or > 80
- Subjects with increased blood glucose concentration, but without a history of diabetes (stress hyperglycemia)
- Patients on an insulin pump
- Patients with a history of clinically significant hepatic disease (cirrhosis, jaundice, end-stage liver disease, portal hypertension) and end- stage renal disease
- Current or recent (within 3 months) treatment with oral or injectable corticosteroid, parenteral nutrition and immunosuppressive treatment
- Mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study
- Female subjects whom are pregnant or breast-feeding at time of qualifying outpatient procedure
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group 1-Regular Insulin
Intravenous Regular Insulin will be administered for a preoperative Blood glucose of greater than 180.
|
Group 1 Treatment Arm,Follow dosing for BG >180 per the following formula:
Other Names:
|
Active Comparator: Group 2-Humalog
Subcutaneous Humalog will be administered for a preoperative Blood glucose of greater than 180
|
Group 2 treatment arm. Follow dosing for Blood glucose > 180, per the following formula:
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
BG concentration differences at 1 and 2 hours post intervention and post operatively
Time Frame: one and two hours post intervention, post operative period
|
Compare the difference in Blood glucose concentration at one and two hours after the administration of corrective doses of regular and humalog insulin and immediately following ambulatory surgery.
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one and two hours post intervention, post operative period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number and percentage of target BG readings
Time Frame: From time of treatment until patient discharge (an average of three hours, less than one day)
|
Investigators will determine the number and percentage of patients in each group with BG readings within the target range ( 80-180 mg/dl)
|
From time of treatment until patient discharge (an average of three hours, less than one day)
|
Episodes of hypoglycemia
Time Frame: time of intervention to time of patient discharge (an average of three hours, less than one day)
|
Investigators will assess if there is any difference in the number of hypoglycemic events between the two treatment groups and further assess the rate and frequency of hypoglycemia (<70 mg/dl) and severe hypoglycemia (<40 mg/dl).
|
time of intervention to time of patient discharge (an average of three hours, less than one day)
|
Episodes of hyperglycemia
Time Frame: time of treatment to time of patient discharge (an average of three hours, less than one day)
|
Investigators will calculate the number of patients and percent of BG readings with hyperglycemia (>180 mg/dl) and severe hyperglycemia (>300 mg/dl)in each group.
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time of treatment to time of patient discharge (an average of three hours, less than one day)
|
Total dose of insulin
Time Frame: time of intervention to time of patient discharge (an average of three hours, less than one day)
|
Calculate total dosage of insulin administered to each patient
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time of intervention to time of patient discharge (an average of three hours, less than one day)
|
Change in glucose concentration from baseline to one, two and three hours post treatment
Time Frame: time of baseline BG to time of last BG measurement (prior to discharge, less than one day)
|
Change in glucose concentration from baseline (prior to insulin administration) to one hour, two hours and three hours (if patient present) after insulin administration
|
time of baseline BG to time of last BG measurement (prior to discharge, less than one day)
|
Number of perioperative complications
Time Frame: start of surgery to time of patient discharge (less than one day)
|
Investigators will record the number of perioperative complications (cardiovascular, respiratory or other medical complications) or need for hospital admission
|
start of surgery to time of patient discharge (less than one day)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Carlson Karen, MD, Emory University
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00067662
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