Logo 1 Logo 2

Clinical Trial Details

Trial ID: L7107
Source ID: NCT01971047
Associated Drug: Regular Insulin
Title: Safety and Efficacy Study of Correcting Hyperglycemia in Patients With Diabetes Having Out-patient Surgery
Acronym:
Status: WITHDRAWN
Study Results: NO
Results:
Conditions: Type 1 Diabetes|Type 2 Diabetes
Interventions: DRUG: Regular Insulin|DRUG: Humalog
Outcome Measures: Primary: BG concentration differences at 1 and 2 hours post intervention and post operatively, 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., one and two hours post intervention, post operative period | Secondary: Number and percentage of target BG readings, 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, 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, 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., time of treatment to time of patient discharge (an average of three hours, less than one day)|Total dose of insulin, Calculate total dosage of insulin administered to each patient, 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, 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, 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)
Sponsor/Collaborators: Sponsor: Emory University
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 0
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2013-10
Completion Date: 2018-09
Results First Posted:
Last Update Posted: 2017-03-15
Locations: Emory Healthcare Ambulatory Surgical Center, Atlanta, Georgia, 30322, United States
URL: https://clinicaltrials.gov/show/NCT01971047