Safety and Efficacy Study of Correcting Hyperglycemia in Patients With Diabetes Having Out-patient Surgery

• Status: Withdrawn
• Trial end date: 2018-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University
• Treatments: Insulin; Insulin Lispro; Insulin, Globin Zinc

Criteria

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