Type2 Diabetes Mellitus
Conditions
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.
Interventions
OTHER25% 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.
Sponsors
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Open-label randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pre-operative Fasting Blood Glucose, as Measured by Standardized Point of Care Capillary Blood Glucose (CBG) Device in the Pre-op Holding Area. | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Incidence of Preoperative Hypoglycemia | 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 |
| Incidence of Preoperative Hypoglycemia Requiring Ingestion of Juice Prior to Arrival to the Hospital | 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 |
| Incidence of Preoperative Hyperglycemia | 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 |
| Mean 24-hour Glucose Postoperatively | Anesthesia stop time - 24 hours postoperatively | — |
| 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 | Anesthesia stop time - 24 hours postoperatively. | Capillary or arterial/venous blood glucose level \>179 mg/dl |
| Incidence of Symptomatic Hypoglycemia Requiring Treatment in the PACU to 24 Hours Post-operatively | Anesthesia stop time - 24 hours postoperatively. | Capillary or arterial/venous blood glucose level \<70 mg/dl |
| Incidence of Hypoglycemia in the PACU to 24 Hours Post-operatively | Anesthesia stop time - 24 hours postoperatively. | Capillary or arterial/venous blood glucose level \<80 mg/dl |
| Incidence of Intraoperative Hyperglycemia | 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 |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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%. | 20 |
| 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. | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | 50% Reduction of Basal Insulin Dose | 25% Reduction of Basal Insulin Dose | Total |
|---|---|---|---|
| Age, Continuous | 60.6 years STANDARD_DEVIATION 11.4 | 57.9 years STANDARD_DEVIATION 11.4 | 59.2 years STANDARD_DEVIATION 11 |
| BMI | 35.8 Kg/m2 STANDARD_DEVIATION 10.2 | 39.9 Kg/m2 STANDARD_DEVIATION 8.7 | 37.8 Kg/m2 STANDARD_DEVIATION 9.6 |
| Height | 172.1 cm STANDARD_DEVIATION 11.7 | 166.4 cm STANDARD_DEVIATION 10.1 | 169.3 cm STANDARD_DEVIATION 11.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 16 Participants | 19 Participants | 35 Participants |
| Sex: Female, Male Female | 16 Participants | 19 Participants | 35 Participants |
| Sex: Female, Male Male | 4 Participants | 1 Participants | 5 Participants |
| Weight | 105.9 Kg STANDARD_DEVIATION 30.5 | 110.0 Kg STANDARD_DEVIATION 23.3 | 108.0 Kg STANDARD_DEVIATION 26.9 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
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
Time frame: Hospital arrival - Anesthesia start time. The time period did not exceed 4 hours, considering that surgeries were scheduled to be morning cases.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 50% Reduction of Basal Insulin Dose | 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 |
| 25% Reduction of Basal Insulin Dose | Pre-operative Fasting Blood Glucose, as Measured by Standardized Point of Care Capillary Blood Glucose (CBG) Device in the Pre-op Holding Area. | 152.5 mg/dl | Standard Deviation 44.8 |
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
Time frame: Anesthesia stop time - 24 hours postoperatively.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 50% Reduction of Basal Insulin Dose | Incidence of Hyperglycemia in the Post-anesthesia Care Unit (PACU) to 24 Hours Post-operatively | 9 Participants |
| 25% Reduction of Basal Insulin Dose | Incidence of Hyperglycemia in the Post-anesthesia Care Unit (PACU) to 24 Hours Post-operatively | 15 Participants |
Secondary
Incidence of Hypoglycemia in the PACU to 24 Hours Post-operatively
Capillary or arterial/venous blood glucose level \<80 mg/dl
Time frame: Anesthesia stop time - 24 hours postoperatively.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 50% Reduction of Basal Insulin Dose | Incidence of Hypoglycemia in the PACU to 24 Hours Post-operatively | 1 Participants |
| 25% Reduction of Basal Insulin Dose | Incidence of Hypoglycemia in the PACU to 24 Hours Post-operatively | 5 Participants |
Secondary
Incidence of Intraoperative Hyperglycemia
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.
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 50% Reduction of Basal Insulin Dose | Incidence of Intraoperative Hyperglycemia | 7 Participants |
| 25% Reduction of Basal Insulin Dose | Incidence of Intraoperative Hyperglycemia | 6 Participants |
Secondary
Incidence of Patients Requiring Initiation of Perioperative IV Insulin Drip
Time frame: Hospital arrival - 24 hours postoperatively.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 50% Reduction of Basal Insulin Dose | Incidence of Patients Requiring Initiation of Perioperative IV Insulin Drip | 0 Participants |
| 25% Reduction of Basal Insulin Dose | Incidence of Patients Requiring Initiation of Perioperative IV Insulin Drip | 0 Participants |
Secondary
Incidence of Preoperative Hyperglycemia
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 50% Reduction of Basal Insulin Dose | Incidence of Preoperative Hyperglycemia | 5 Participants |
| 25% Reduction of Basal Insulin Dose | Incidence of Preoperative Hyperglycemia | 5 Participants |
Secondary
Incidence of Preoperative Hypoglycemia
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 50% Reduction of Basal Insulin Dose | Incidence of Preoperative Hypoglycemia | 1 Participants |
| 25% Reduction of Basal Insulin Dose | Incidence of Preoperative Hypoglycemia | 1 Participants |
Secondary
Incidence of Preoperative Hypoglycemia Requiring Ingestion of Juice Prior to Arrival to the Hospital
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 50% Reduction of Basal Insulin Dose | Incidence of Preoperative Hypoglycemia Requiring Ingestion of Juice Prior to Arrival to the Hospital | 0 Participants |
| 25% Reduction of Basal Insulin Dose | Incidence of Preoperative Hypoglycemia Requiring Ingestion of Juice Prior to Arrival to the Hospital | 0 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 50% Reduction of Basal Insulin Dose | Incidence of Surgical Delay or Cancellation Due to Hyperglycemia | 0 Participants |
| 25% Reduction of Basal Insulin Dose | Incidence of Surgical Delay or Cancellation Due to Hyperglycemia | 0 Participants |
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
Time frame: Anesthesia stop time - 24 hours postoperatively.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 50% Reduction of Basal Insulin Dose | Incidence of Symptomatic Hypoglycemia Requiring Treatment in the PACU to 24 Hours Post-operatively | 1 Participants |
| 25% Reduction of Basal Insulin Dose | Incidence of Symptomatic Hypoglycemia Requiring Treatment in the PACU to 24 Hours Post-operatively | 0 Participants |
Secondary
Mean 24-hour Glucose Postoperatively
Time frame: Anesthesia stop time - 24 hours postoperatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 50% Reduction of Basal Insulin Dose | Mean 24-hour Glucose Postoperatively | 158.5 mg/dl | Standard Deviation 31.7 |
| 25% Reduction of Basal Insulin Dose | Mean 24-hour Glucose Postoperatively | 165.2 mg/dl | Standard Deviation 28.1 |