Basal Insulin Strategies Before Surgery

NCT ID: NCT03104738

Last Updated: 2019-09-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-20
• Study Completion Date: 2016-08-18

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.

Conditions

Type2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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%.

Group Type: NO_INTERVENTION

No interventions assigned to this group

25% reduction of basal insulin dose

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

Group Type: EXPERIMENTAL

25% reduction of basal insulin dose

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Barbara Rogers

MD, Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Barbara Rogers, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Other Identifiers

2013H0232

Identifier Type: -

Identifier Source: org_study_id