Clinical trial NCT03104738: Basal Insulin Strategies Before Surgery
Official title: A Comparison of the Impact of Basal Insulin Dosing Strategies on Next-day Surgery Blood Glucose Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type2 Diabetes Mellitus
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2017-04-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open-label randomized controlled trial
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Pre-operative Fasting Blood Glucose, as Measured by Standardized Point of Care Capillary Blood Glucose (CBG) Device in the Pre-op Holding Area.
timeFrame: Hospital arrival - Anesthesia start time. The time period did not exceed 4 hours, considering that surgeries were scheduled to be morning cases.
Secondary outcomes:
measure: Incidence of Preoperative Hypoglycemia
timeFrame: Hospital arrival - Anesthesia start time. The time period did not exceed 4 hours, considering that surgeries were scheduled to be morning cases.
measure: Incidence of Preoperative Hypoglycemia Requiring Ingestion of Juice Prior to Arrival to the Hospital
timeFrame: 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.
measure: Incidence of Preoperative Hyperglycemia
timeFrame: Hospital arrival - Anesthesia start time. The time period did not exceed 4 hours, considering that surgeries were scheduled to be morning cases
measure: Incidence of Intraoperative Hyperglycemia
timeFrame: Anesthesia start time - Anesthesia stop time. The time period did not exceed 10 hours, considering type of surgeries or procedures.
measure: Incidence of Patients Requiring Initiation of Perioperative IV Insulin Drip
timeFrame: Hospital arrival - 24 hours postoperatively.
measure: Incidence of Hyperglycemia in the Post-anesthesia Care Unit (PACU) to 24 Hours Post-operatively
timeFrame: Anesthesia stop time - 24 hours postoperatively.
measure: Incidence of Symptomatic Hypoglycemia Requiring Treatment in the PACU to 24 Hours Post-operatively
timeFrame: Anesthesia stop time - 24 hours postoperatively.
measure: Incidence of Hypoglycemia in the PACU to 24 Hours Post-operatively
timeFrame: Anesthesia stop time - 24 hours postoperatively.
measure: Incidence of Surgical Delay or Cancellation Due to Hyperglycemia
timeFrame: Hospital arrival - Surgery start date/time. The time period did not exceed 4 hours, considering that surgeries were scheduled to be morning cases
measure: Mean 24-hour Glucose Postoperatively
timeFrame: Anesthesia stop time - 24 hours postoperatively
Other outcomes:
Locations:
Study officials:
affiliation: Ohio State University
name: Barbara Rogers, MD
role: PRINCIPAL_INVESTIGATOR
References: