Basal Insulin Strategies Before Surgery

The Ohio State University

Status: Completed

Conditions: Type2 Diabetes Mellitus

Treatments: Other: 25% reduction of basal insulin dose

Study type: Interventional

Funder types: Other

Identifiers

NCT03104738

2013H0232

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

50% reduction of basal insulin dose

No Intervention group

Description:

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 group

Description:

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

Treatment:

Other: 25% reduction of basal insulin dose