Basal Insulin Strategies Before Surgery

NCT03104738 | Completed Results

• 1 other identifier: 2013H0232
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• 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.

• 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.

• 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

• Incidence of Intraoperative Hyperglycemia

  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.

Study Arms (2)

50% reduction of basal insulin dose

NO INTERVENTION

This is the institutional standard of care. The evening before surgery, 20 subjects will reduce their basal insulin dose to 50%.

25% reduction of basal insulin dose

EXPERIMENTAL

The evening before surgery, 20 subjects will reduce their basal insulin dose to 25%.

Other: 25% reduction of basal insulin dose

Interventions

25% reduction of basal insulin dose OTHER

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.

25% reduction of basal insulin dose

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead

Limitations and Caveats

Intraoperative measurement of blood glucose was missing on 4 subjects. This measurement is Standard of care at our institution, nevertheless,on shorter surgeries this measurement was not perform, leading to missing data on this study.

Results Point of Contact

• Title: Ana Mavarez-Martinez, PostDoctoral Reseacher
• Organization: The Ohio State University

ana.mavarezmartinez@osumc.edu

614-293-3559

Study Officials

• Barbara Rogers, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Assistant Professor

Model Details: Open-label randomized controlled trial

Study Record Dates

• First Submitted: March 28, 2017
• First Posted: April 7, 2017
• Study Start: November 20, 2013
• Primary Completion: August 18, 2016
• Study Completion: August 18, 2016
• Last Updated: September 6, 2019
• Results First Posted: November 5, 2018

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share