Basal Insulin Strategies Before Surgery

Not Applicable

Completed

• Conditions: Type2 Diabetes Mellitus
• Interventions: Other: 25% reduction of basal insulin dose

• Registration Number: NCT03104738
• Lead Sponsor: Ohio State University

Brief Summary

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.

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 Timeline

• Study Start: 2013-11-20
• Primary Completion: 2016-08-18
• Study Completion: 2016-08-18
• Study First Submitted: 2017-03-28
• Study First Submitted QC: 2017-04-03
• Study First Posted: 2017-04-07
• Results First Submitted: 2017-06-12
• Results First Submitted QC: 2018-04-03
• Results First Posted: 2018-11-05
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-03
• Last Update Posted: 2019-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
25% reduction of basal insulin dose	25% reduction of basal insulin dose	The evening before surgery, 20 subjects will reduce their basal insulin dose to 25%.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Incidence of Preoperative Hypoglycemia Requiring Ingestion of Juice Prior to Arrival to the Hospital	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.	Capillary blood glucose level \<70 mg/dl
Incidence of Preoperative Hyperglycemia	Hospital arrival - Anesthesia start time. The time period did not exceed 4 hours, considering that surgeries were scheduled to be morning cases	Capillary blood glucose level \>179 mg/dl
Incidence of Patients Requiring Initiation of Perioperative IV Insulin Drip	Hospital arrival - 24 hours postoperatively.
Incidence of Symptomatic Hypoglycemia Requiring Treatment in the PACU to 24 Hours Post-operatively	Anesthesia stop time - 24 hours postoperatively.	Capillary or arterial/venous blood glucose level \<70 mg/dl
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
Incidence of Preoperative Hypoglycemia	Hospital arrival - Anesthesia start time. The time period did not exceed 4 hours, considering that surgeries were scheduled to be morning cases.	Capillary blood glucose level \<80 mg/dl
Incidence of Intraoperative Hyperglycemia	Anesthesia start time - Anesthesia stop time. The time period did not exceed 10 hours, considering type of surgeries or procedures.	Capillary or arterial/venous blood glucose level \>179 mg/dl
Incidence of Hyperglycemia in the Post-anesthesia Care Unit (PACU) to 24 Hours Post-operatively	Anesthesia stop time - 24 hours postoperatively.	Capillary or arterial/venous blood glucose level \>179 mg/dl
Incidence of Hypoglycemia in the PACU to 24 Hours Post-operatively	Anesthesia stop time - 24 hours postoperatively.	Capillary or arterial/venous blood glucose level \<80 mg/dl
Mean 24-hour Glucose Postoperatively	Anesthesia stop time - 24 hours postoperatively