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

NCT01971047 | Withdrawn Phase 4

• 1 other identifier: IRB00067662
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 1 Diabetes; Type 2 Diabetes

Keywords

Diabetes; Surgery; anesthesiology; endocrinology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Number and percentage of target BG readings

  From time of treatment until patient discharge (an average of three hours, less than one day)

• Episodes of hypoglycemia

  time of intervention to time of patient discharge (an average of three hours, less than one day)

• Episodes of hyperglycemia

  time of treatment to time of patient discharge (an average of three hours, less than one day)

• Total dose of insulin

  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 of baseline BG to time of last BG measurement (prior to discharge, less than one day)

Study Arms (2)

Group 1-Regular Insulin

ACTIVE COMPARATOR

Intravenous Regular Insulin will be administered for a preoperative Blood glucose of greater than 180.

Drug: Regular Insulin

Group 2-Humalog

ACTIVE COMPARATOR

Subcutaneous Humalog will be administered for a preoperative Blood glucose of greater than 180

Drug: Humalog

Interventions

Regular Insulin DRUG

Group 1 Treatment Arm,Follow dosing for BG \>180 per the following formula: 1. Patients with Type 2 Diabetes to receive dosage based on the formula: (BG-120)/30= # units of insulin 2. Patients with Type 1 Diabetes to receive dosage based on the formula: (BG-120)/40=# units of insulin 3. Patients with Type 1 Diabetes and Type 2 Diabetes over the age of 70 or with chronic kidney disease to receive dosage based on the formula: (BG-120)/50=# units of insulin 4. Consider repeating dose if BG\>240 mg/dl after 2 hours of initial dose

Also known as: Novolin

Group 1-Regular Insulin

Humalog DRUG

Group 2 treatment arm. Follow dosing for Blood glucose \> 180, per the following formula: 1. Patients with Type 2 Diabetes to receive dosage based on the formula: (BG-120)/30= # units of insulin 2. Patients with Type 1 Diabetes to receive dosage based on the formula: (BG-120)/40=# units of insulin 3. Patients with Type 1 Diabetes and Type 2 Diabetes over the age of 70 or with chronic kidney disease to receive dosage based on the formula: (BG-120)/50=# units of insulin 4. Consider repeating dose if BG\>240 mg/dl after 2 hours of initial dose

Also known as: Lispro

Group 2-Humalog

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Emory Healthcare Ambulatory Surgical Center

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Insulin; Insulin Lispro

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Short-Acting

Study Officials

• Carlson Karen, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Principal Investigator

Study Record Dates

• First Submitted: September 26, 2013
• First Posted: October 28, 2013
• Study Start: October 1, 2013
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: March 15, 2017

Record last verified: 2017-03

Locations

US (1)