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Completed

NCT Number: NCT03104738

Basal Insulin Strategies Before Surgery

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.

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Key information

Conditions

Type2 Diabetes Mellitus

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

    Time frame: 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 outcomes

  1. Incidence of Preoperative Hypoglycemia

    Time frame: 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

  2. Incidence of Preoperative Hypoglycemia Requiring Ingestion of Juice Prior to Arrival to the Hospital

    Time frame: 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

  3. Incidence of Preoperative Hyperglycemia

    Time frame: 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

  4. Incidence of Intraoperative Hyperglycemia

    Time frame: 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

  5. Incidence of Patients Requiring Initiation of Perioperative IV Insulin Drip

    Time frame: Hospital arrival - 24 hours postoperatively.

  6. Incidence of Hyperglycemia in the Post-anesthesia Care Unit (PACU) to 24 Hours Post-operatively

    Time frame: Anesthesia stop time - 24 hours postoperatively.

    Capillary or arterial/venous blood glucose level >179 mg/dl

  7. Incidence of Symptomatic Hypoglycemia Requiring Treatment in the PACU to 24 Hours Post-operatively

    Time frame: Anesthesia stop time - 24 hours postoperatively.

    Capillary or arterial/venous blood glucose level <70 mg/dl

  8. Incidence of Hypoglycemia in the PACU to 24 Hours Post-operatively

    Time frame: Anesthesia stop time - 24 hours postoperatively.

    Capillary or arterial/venous blood glucose level <80 mg/dl

  9. Incidence of Surgical Delay or Cancellation Due to Hyperglycemia

    Time frame: Hospital arrival - Surgery start date/time. The time period did not exceed 4 hours, considering that surgeries were scheduled to be morning cases

  10. Mean 24-hour Glucose Postoperatively

    Time frame: Anesthesia stop time - 24 hours postoperatively

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Official study title

A Comparison of the Impact of Basal Insulin Dosing Strategies on Next-day Surgery Blood Glucose Control

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Apr 7, 2017
Registry last updated
Sep 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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