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Basal Insulin Strategies Before Surgery

Primary Purpose

Type2 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
25% reduction of basal insulin dose
Sponsored by
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type2 Diabetes Mellitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    50% reduction of basal insulin dose

    25% reduction of basal insulin dose

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Incidence of Preoperative Hypoglycemia
    Capillary blood glucose level <80 mg/dl
    Incidence of Preoperative Hypoglycemia Requiring Ingestion of Juice Prior to Arrival to the Hospital
    Capillary blood glucose level <70 mg/dl
    Incidence of Preoperative Hyperglycemia
    Capillary blood glucose level >179 mg/dl
    Incidence of Intraoperative Hyperglycemia
    Capillary or arterial/venous blood glucose level >179 mg/dl
    Incidence of Patients Requiring Initiation of Perioperative IV Insulin Drip
    Incidence of Hyperglycemia in the Post-anesthesia Care Unit (PACU) to 24 Hours Post-operatively
    Capillary or arterial/venous blood glucose level >179 mg/dl
    Incidence of Symptomatic Hypoglycemia Requiring Treatment in the PACU to 24 Hours Post-operatively
    Capillary or arterial/venous blood glucose level <70 mg/dl
    Incidence of Hypoglycemia in the PACU to 24 Hours Post-operatively
    Capillary or arterial/venous blood glucose level <80 mg/dl
    Incidence of Surgical Delay or Cancellation Due to Hyperglycemia
    Mean 24-hour Glucose Postoperatively

    Full Information

    First Posted
    March 28, 2017
    Last Updated
    September 3, 2019
    Sponsor
    Ohio State University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03104738
    Brief Title
    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

    2. Study Status

    Record Verification Date
    September 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    November 20, 2013 (Actual)
    Primary Completion Date
    August 18, 2016 (Actual)
    Study Completion Date
    August 18, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ohio State University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Type2 Diabetes Mellitus

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Open-label randomized controlled trial
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    50% reduction of basal insulin dose
    Arm Type
    No Intervention
    Arm Description
    This is the institutional standard of care. The evening before surgery, 20 subjects will reduce their basal insulin dose to 50%.
    Arm Title
    25% reduction of basal insulin dose
    Arm Type
    Experimental
    Arm Description
    The evening before surgery, 20 subjects will reduce their basal insulin dose to 25%.
    Intervention Type
    Other
    Intervention Name(s)
    25% reduction of basal insulin dose
    Intervention Description
    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 Outcome Measure Information:
    Title
    Pre-operative Fasting Blood Glucose, as Measured by Standardized Point of Care Capillary Blood Glucose (CBG) Device in the Pre-op Holding Area.
    Description
    Capillary blood glucose before surgery, considering a fasting period up to 8 hours prior fasting blood glucose
    Time Frame
    Hospital arrival - Anesthesia start time. The time period did not exceed 4 hours, considering that surgeries were scheduled to be morning cases.
    Secondary Outcome Measure Information:
    Title
    Incidence of Preoperative Hypoglycemia
    Description
    Capillary blood glucose level <80 mg/dl
    Time Frame
    Hospital arrival - Anesthesia start time. The time period did not exceed 4 hours, considering that surgeries were scheduled to be morning cases.
    Title
    Incidence of Preoperative Hypoglycemia Requiring Ingestion of Juice Prior to Arrival to the Hospital
    Description
    Capillary blood glucose level <70 mg/dl
    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.
    Title
    Incidence of Preoperative Hyperglycemia
    Description
    Capillary blood glucose level >179 mg/dl
    Time Frame
    Hospital arrival - Anesthesia start time. The time period did not exceed 4 hours, considering that surgeries were scheduled to be morning cases
    Title
    Incidence of Intraoperative Hyperglycemia
    Description
    Capillary or arterial/venous blood glucose level >179 mg/dl
    Time Frame
    Anesthesia start time - Anesthesia stop time. The time period did not exceed 10 hours, considering type of surgeries or procedures.
    Title
    Incidence of Patients Requiring Initiation of Perioperative IV Insulin Drip
    Time Frame
    Hospital arrival - 24 hours postoperatively.
    Title
    Incidence of Hyperglycemia in the Post-anesthesia Care Unit (PACU) to 24 Hours Post-operatively
    Description
    Capillary or arterial/venous blood glucose level >179 mg/dl
    Time Frame
    Anesthesia stop time - 24 hours postoperatively.
    Title
    Incidence of Symptomatic Hypoglycemia Requiring Treatment in the PACU to 24 Hours Post-operatively
    Description
    Capillary or arterial/venous blood glucose level <70 mg/dl
    Time Frame
    Anesthesia stop time - 24 hours postoperatively.
    Title
    Incidence of Hypoglycemia in the PACU to 24 Hours Post-operatively
    Description
    Capillary or arterial/venous blood glucose level <80 mg/dl
    Time Frame
    Anesthesia stop time - 24 hours postoperatively.
    Title
    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
    Title
    Mean 24-hour Glucose Postoperatively
    Time Frame
    Anesthesia stop time - 24 hours postoperatively

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Barbara Rogers, MD
    Organizational Affiliation
    Ohio State University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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