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

Emory University

Status and phase

Withdrawn

Phase 4

Conditions

Type 1 Diabetes

Type 2 Diabetes

Treatments

Drug: Humalog

Drug: Regular Insulin

Study type

Interventional

Funder types

Other

Identifiers

NCT01971047

IRB00067662

Details and patient eligibility

About

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.

Full description

Investigators plan to randomize a total of 200 male and female subjects with type 1 and type 2 diabetes,having an out patient surgical procedure, meeting inclusion criteria to receive corrective doses of IV regular insulin (Group I) or SC humalog insulin (Group II). The dosing formula is per Emory University Outpatient Surgical Center protocol for treating hyperglycemia and is the same for both groups. All patients with diabetes will undergo a blood sugar measurement upon arrival to the ASC using the Accuchek blood glucose meter. An admission blood sugar of >180 in a patient with diabetes qualifies the patient for study screening. Subjects will be approached after confirmation of eligibility for the study. Randomization, then treatment, will occur immediately following written informed consent. Demographic data will be recorded.A medical history with detailed history of diabetes will be obtained and surgical and anesthesia details and length of stay recorded. Blood sugar levels will be checked hourly until the patient is ready for discharge. Subsequent treatment will follow the hyperglycemia protocol. All blood sugar results and doses of insulin will be recorded. The subject's participation will end at the time of discharge from the Ambulatory Surgical Center.

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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