Trial Outcomes & Findings for Basal Insulin Strategies Before Surgery (NCT NCT03104738)

NCT ID: NCT03104738

Last Updated: 2019-09-06

Results Overview

Capillary blood glucose before surgery, considering a fasting period up to 8 hours prior fasting blood glucose

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 40 participants
• Primary outcome timeframe: Hospital arrival - Anesthesia start time. The time period did not exceed 4 hours, considering that surgeries were scheduled to be morning cases.
• Results posted on: 2019-09-06

Participant Flow

Participant milestones

Measure	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%.	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.
Overall Study STARTED	20	20
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Basal Insulin Strategies Before Surgery

Baseline characteristics by cohort

Measure	50% Reduction of Basal Insulin Dose n=20 Participants 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 n=20 Participants 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.	Total n=40 Participants Total of all reporting groups
Age, Continuous	60.6 years STANDARD_DEVIATION 11.4 • n=5 Participants	57.9 years STANDARD_DEVIATION 11.4 • n=7 Participants	59.2 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	19 Participants n=7 Participants	35 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants	19 Participants n=7 Participants	35 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Weight	105.9 Kg STANDARD_DEVIATION 30.5 • n=5 Participants	110.0 Kg STANDARD_DEVIATION 23.3 • n=7 Participants	108.0 Kg STANDARD_DEVIATION 26.9 • n=5 Participants
Height	172.1 cm STANDARD_DEVIATION 11.7 • n=5 Participants	166.4 cm STANDARD_DEVIATION 10.1 • n=7 Participants	169.3 cm STANDARD_DEVIATION 11.2 • n=5 Participants
BMI	35.8 Kg/m2 STANDARD_DEVIATION 10.2 • n=5 Participants	39.9 Kg/m2 STANDARD_DEVIATION 8.7 • n=7 Participants	37.8 Kg/m2 STANDARD_DEVIATION 9.6 • n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	50% Reduction of Basal Insulin Dose n=20 Participants 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 n=20 Participants 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.
Pre-operative Fasting Blood Glucose, as Measured by Standardized Point of Care Capillary Blood Glucose (CBG) Device in the Pre-op Holding Area.	144.0 mg/dl Standard Deviation 39.0	152.5 mg/dl Standard Deviation 44.8

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	50% Reduction of Basal Insulin Dose n=20 Participants 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 n=20 Participants 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.
Incidence of Preoperative Hypoglycemia	1 Participants	1 Participants

SECONDARY outcome

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.

Capillary blood glucose level <70 mg/dl

Outcome measures

Measure	50% Reduction of Basal Insulin Dose n=20 Participants 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 n=20 Participants 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.
Incidence of Preoperative Hypoglycemia Requiring Ingestion of Juice Prior to Arrival to the Hospital	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	50% Reduction of Basal Insulin Dose n=20 Participants 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 n=20 Participants 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.
Incidence of Preoperative Hyperglycemia	5 Participants	5 Participants

SECONDARY outcome

Timeframe: Anesthesia start time - Anesthesia stop time. The time period did not exceed 10 hours, considering type of surgeries or procedures.

Population: 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.

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

Outcome measures

Measure	50% Reduction of Basal Insulin Dose n=19 Participants 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 n=17 Participants 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.
Incidence of Intraoperative Hyperglycemia	7 Participants	6 Participants

SECONDARY outcome

Timeframe: Hospital arrival - 24 hours postoperatively.

Outcome measures

Measure	50% Reduction of Basal Insulin Dose n=20 Participants 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 n=20 Participants 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.
Incidence of Patients Requiring Initiation of Perioperative IV Insulin Drip	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Anesthesia stop time - 24 hours postoperatively.

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

Outcome measures

Measure	50% Reduction of Basal Insulin Dose n=20 Participants 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 n=20 Participants 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.
Incidence of Hyperglycemia in the Post-anesthesia Care Unit (PACU) to 24 Hours Post-operatively	9 Participants	15 Participants

SECONDARY outcome

Timeframe: Anesthesia stop time - 24 hours postoperatively.

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

Outcome measures

Measure	50% Reduction of Basal Insulin Dose n=20 Participants 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 n=20 Participants 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.
Incidence of Symptomatic Hypoglycemia Requiring Treatment in the PACU to 24 Hours Post-operatively	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Anesthesia stop time - 24 hours postoperatively.

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

Outcome measures

Measure	50% Reduction of Basal Insulin Dose n=20 Participants 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 n=20 Participants 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.
Incidence of Hypoglycemia in the PACU to 24 Hours Post-operatively	1 Participants	5 Participants

SECONDARY outcome

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

Outcome measures

Measure	50% Reduction of Basal Insulin Dose n=20 Participants 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 n=20 Participants 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.
Incidence of Surgical Delay or Cancellation Due to Hyperglycemia	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Anesthesia stop time - 24 hours postoperatively

Outcome measures

Measure	50% Reduction of Basal Insulin Dose n=20 Participants 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 n=20 Participants 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.
Mean 24-hour Glucose Postoperatively	158.5 mg/dl Standard Deviation 31.7	165.2 mg/dl Standard Deviation 28.1

Adverse Events

50% Reduction of Basal Insulin Dose

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

25% Reduction of Basal Insulin Dose

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ana Mavarez-Martinez, PostDoctoral Reseacher

The Ohio State University

Phone: 614-293-3559

Email: ana.mavarezmartinez@osumc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place