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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 50% reduction of basal insulin dose | No Intervention | 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 | The evening before surgery, 20 subjects will reduce their basal insulin dose to 25%. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Hospital arrival - Anesthesia start time. The time period did not exceed 4 hours, considering that surgeries were scheduled to be morning cases. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Preoperative Hypoglycemia | Capillary blood glucose level <80 mg/dl | Hospital arrival - Anesthesia start time. The time period did not exceed 4 hours, considering that surgeries were scheduled to be morning cases. |
| Incidence of Preoperative Hypoglycemia Requiring Ingestion of Juice Prior to Arrival to the Hospital |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barbara Rogers, MD | Ohio State University | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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%. |
| FG001 | 25% Reduction of Basal Insulin Dose | The evening before surgery, 20 subjects will reduce their basal insulin dose to 25%. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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%. |
| BG001 | 25% Reduction of Basal Insulin Dose |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Standard Deviation | mg/dl | Hospital arrival - Anesthesia start time. The time period did not exceed 4 hours, considering that surgeries were scheduled to be morning cases. |
|
Since subject hospital arrival for the scheduled surgery until postoperative hour 24.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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%. |
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Intraoperative measurement of blood glucose was missing on 4 subjects. This measurement is Standard of care at our institution, nevertheless,on shorter surgeries this measurement was not perform, leading to missing data on this study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ana Mavarez-Martinez, PostDoctoral Reseacher | The Ohio State University | 614-293-3559 | ana.mavarezmartinez@osumc.edu |
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Open-label randomized controlled trial
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|
Capillary blood glucose level <70 mg/dl |
| 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. |
| Incidence of Preoperative Hyperglycemia | Capillary blood glucose level >179 mg/dl | Hospital arrival - Anesthesia start time. The time period did not exceed 4 hours, considering that surgeries were scheduled to be morning cases |
| Incidence of Intraoperative Hyperglycemia | Capillary or arterial/venous blood glucose level >179 mg/dl | Anesthesia start time - Anesthesia stop time. The time period did not exceed 10 hours, considering type of surgeries or procedures. |
| Incidence of Patients Requiring Initiation of Perioperative IV Insulin Drip | Hospital arrival - 24 hours postoperatively. |
| 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 | Anesthesia stop time - 24 hours postoperatively. |
| Incidence of Symptomatic Hypoglycemia Requiring Treatment in the PACU to 24 Hours Post-operatively | Capillary or arterial/venous blood glucose level <70 mg/dl | Anesthesia stop time - 24 hours postoperatively. |
| Incidence of Hypoglycemia in the PACU to 24 Hours Post-operatively | Capillary or arterial/venous blood glucose level <80 mg/dl | Anesthesia stop time - 24 hours postoperatively. |
| Incidence of Surgical Delay or Cancellation Due to Hyperglycemia | Hospital arrival - Surgery start date/time. The time period did not exceed 4 hours, considering that surgeries were scheduled to be morning cases |
| Mean 24-hour Glucose Postoperatively | Anesthesia stop time - 24 hours postoperatively |
The evening before surgery, 20 subjects will reduce their basal insulin dose to 25%.
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.
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Weight | Mean | Standard Deviation | Kg |
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| Height | Mean | Standard Deviation | cm |
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| BMI | Mean | Standard Deviation | Kg/m2 |
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| Secondary | Incidence of Preoperative Hypoglycemia | Capillary blood glucose level <80 mg/dl | Posted | Count of Participants | Participants | Hospital arrival - Anesthesia start time. The time period did not exceed 4 hours, considering that surgeries were scheduled to be morning cases. |
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| Secondary | Incidence of Preoperative Hypoglycemia Requiring Ingestion of Juice Prior to Arrival to the Hospital | Capillary blood glucose level <70 mg/dl | Posted | Count of Participants | Participants | 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. |
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| Secondary | Incidence of Preoperative Hyperglycemia | Capillary blood glucose level >179 mg/dl | Posted | Count of Participants | Participants | Hospital arrival - Anesthesia start time. The time period did not exceed 4 hours, considering that surgeries were scheduled to be morning cases |
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| Secondary | Incidence of Intraoperative Hyperglycemia | Capillary or arterial/venous blood glucose level >179 mg/dl | Out of 20 subjects in the 50% reduction, intraoperative blood glucose level for was not measured on 1 subject; therefore, only 19 subjects were analyzed for this outcome. Out of 20 subjects in the 25% reduction, intraoperative blood glucose level for was not measured on 3 subject; therefore, only 17 subjects were analyzed for this outcome. | Posted | Count of Participants | Participants | Anesthesia start time - Anesthesia stop time. The time period did not exceed 10 hours, considering type of surgeries or procedures. |
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| Secondary | Incidence of Patients Requiring Initiation of Perioperative IV Insulin Drip | Posted | Count of Participants | Participants | Hospital arrival - 24 hours postoperatively. |
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| Secondary | 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 | Posted | Count of Participants | Participants | Anesthesia stop time - 24 hours postoperatively. |
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| Secondary | Incidence of Symptomatic Hypoglycemia Requiring Treatment in the PACU to 24 Hours Post-operatively | Capillary or arterial/venous blood glucose level <70 mg/dl | Posted | Count of Participants | Participants | Anesthesia stop time - 24 hours postoperatively. |
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| Secondary | Incidence of Hypoglycemia in the PACU to 24 Hours Post-operatively | Capillary or arterial/venous blood glucose level <80 mg/dl | Posted | Count of Participants | Participants | Anesthesia stop time - 24 hours postoperatively. |
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| Secondary | Incidence of Surgical Delay or Cancellation Due to Hyperglycemia | Posted | Count of Participants | Participants | Hospital arrival - Surgery start date/time. The time period did not exceed 4 hours, considering that surgeries were scheduled to be morning cases |
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| Secondary | Mean 24-hour Glucose Postoperatively | Posted | Mean | Standard Deviation | mg/dl | Anesthesia stop time - 24 hours postoperatively |
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| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | 25% Reduction of Basal Insulin Dose | The evening before surgery, 20 subjects will reduce their basal insulin dose to 25%. 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. | 0 | 20 | 0 | 20 |
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