Basal Insulin Strategies Before Surgery

A Comparison of the Impact of Basal Insulin Dosing Strategies on Next-day Surgery Blood Glucose Control

Many patients with Type 2 Diabetes Mellitus (T2DM) are currently being managed with Basal Insulin (BI). However, there is little evidence to support guidelines on dosing adjustments in the preoperative period. The Society for Ambulatory Anesthesia does not advise a reduction in the dose of BI preoperatively, unless there is a specific history of hypoglycemia. The Endocrine Society suggests a 50% reduction in BI dose the evening before surgery. The authors hypothesized that a 25% reduction in BI dose the evening before surgery will result in better perioperative blood glucose control compared with our institutional 50% decrease.

Study Overview

• Status: Completed
• Conditions: Type2 Diabetes Mellitus
• Intervention / Treatment: Other: 25% reduction of basal insulin dose

Detailed Description

A total of 40 subjects diagnosed with T2DM taking once-daily evening BI, scheduled to undergo elective surgery under general anesthesia will be consented and randomized in a 1:1 ratio to received either 50% or 25% reduction of their regular evening BI dose on the evening before surgery. Blood glucose levels (BGL) will be recorded perioperatively according to institutional guidelines.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects who have volunteered and consented to participation in the study during their outpatient preoperative anesthesia appointment.
• Type II Diabetics taking once-daily evening basal insulin (glargine or detemir)
• Patients that will undergo general anesthesia
• Patients who have been on basal insulin for ≥ 3months

Exclusion Criteria:

• Inability to read, comprehend, and sign informed consent
• Patients with Type I Diabetes
• Patients who take short-acting insulin boluses which make up greater than 20% of their total daily insulin dose
• Patients who have been on chronic steroids ≥ 5 mg/dl prednisone daily or equivalent for ≥ 1 month within the past 12 months
• Pregnant patients
• Patients on twice-daily dosing of basal insulin
• Patient who take basal insulin in the morning
• Patients with a history of severe hypoglycemia, defined as any event in the previous year requiring assistance of another person to actively administer carbohydrate, glucagons, or other resuscitative actions
• Patients that will undergo cardiac, transplant, or brain surgeries
• Prisoners

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 50% reduction of basal insulin dose; This is the institutional standard of care. The evening before surgery, 20 subjects will reduce their basal insulin dose to 50%.
Experimental: 25% reduction of basal insulin dose; The evening before surgery, 20 subjects will reduce their basal insulin dose to 25%.	Other: 25% reduction of basal insulin dose; Subjects will be instructed to reduce their basal insulin dose to 75% instead of our institutional 50%. Subject must check their own blood sugar before reporting to the hospital for their surgery. If the value is less than 70 or subjects are having symptoms of hypoglycemia, subjects will be instructed to immediately ingest 4-8 oz of fruit juice (without pulp) and call their doctor or the hospital.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pre-operative Fasting Blood Glucose, as Measured by Standardized Point of Care Capillary Blood Glucose (CBG) Device in the Pre-op Holding Area.	Capillary blood glucose before surgery, considering a fasting period up to 8 hours prior fasting blood glucose	Hospital arrival - Anesthesia start time. The time period did not exceed 4 hours, considering that surgeries were scheduled to be morning cases.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Preoperative Hypoglycemia	Capillary blood glucose level <80 mg/dl	Hospital arrival - Anesthesia start time. The time period did not exceed 4 hours, considering that surgeries were scheduled to be morning cases.
Incidence of Preoperative Hypoglycemia Requiring Ingestion of Juice Prior to Arrival to the Hospital	Capillary blood glucose level <70 mg/dl	Basal insulin dose administration the evening before surgery - Hospital arrival the morning of the surgery. The time period did not exceed 12 hours, considering a fasting period up to 8 hours and a preoperative period up to 4 hours.
Incidence of Preoperative Hyperglycemia	Capillary blood glucose level >179 mg/dl	Hospital arrival - Anesthesia start time. The time period did not exceed 4 hours, considering that surgeries were scheduled to be morning cases
Incidence of Intraoperative Hyperglycemia	Capillary or arterial/venous blood glucose level >179 mg/dl	Anesthesia start time - Anesthesia stop time. The time period did not exceed 10 hours, considering type of surgeries or procedures.
Incidence of Patients Requiring Initiation of Perioperative IV Insulin Drip		Hospital arrival - 24 hours postoperatively.
Incidence of Hyperglycemia in the Post-anesthesia Care Unit (PACU) to 24 Hours Post-operatively	Capillary or arterial/venous blood glucose level >179 mg/dl	Anesthesia stop time - 24 hours postoperatively.
Incidence of Symptomatic Hypoglycemia Requiring Treatment in the PACU to 24 Hours Post-operatively	Capillary or arterial/venous blood glucose level <70 mg/dl	Anesthesia stop time - 24 hours postoperatively.
Incidence of Hypoglycemia in the PACU to 24 Hours Post-operatively	Capillary or arterial/venous blood glucose level <80 mg/dl	Anesthesia stop time - 24 hours postoperatively.
Incidence of Surgical Delay or Cancellation Due to Hyperglycemia		Hospital arrival - Surgery start date/time. The time period did not exceed 4 hours, considering that surgeries were scheduled to be morning cases
Mean 24-hour Glucose Postoperatively		Anesthesia stop time - 24 hours postoperatively

Collaborators and Investigators

• Sponsor: Ohio State University
• Investigators: Principal Investigator: Barbara Rogers, MD, Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2013
• Primary Completion (Actual): August 18, 2016
• Study Completion (Actual): August 18, 2016

Study Registration Dates

• First Submitted: March 28, 2017
• First Submitted That Met QC Criteria: April 3, 2017
• First Posted (Actual): April 7, 2017

Study Record Updates

• Last Update Posted (Actual): September 6, 2019
• Last Update Submitted That Met QC Criteria: September 3, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID Numbers: 2013H0232

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No