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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1-Regular Insulin | Active Comparator | Intravenous Regular Insulin will be administered for a preoperative Blood glucose of greater than 180. |
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| Group 2-Humalog | Active Comparator | Subcutaneous Humalog will be administered for a preoperative Blood glucose of greater than 180 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regular Insulin | Drug | Group 1 Treatment Arm,Follow dosing for BG >180 per the following formula:
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carlson Karen, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory Healthcare Ambulatory Surgical Center | Atlanta | Georgia | 30322 | United States |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D007328 | Insulin |
| D061268 | Insulin Lispro |
| ID | Term |
|---|---|
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Humalog | Drug | Group 2 treatment arm. Follow dosing for Blood glucose > 180, per the following formula:
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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) |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061266 | Insulin, Short-Acting |