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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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The main objective of this study is to compare three strategies of evening insulin glargine dosing to preoperative glucose values in patients with diabetes undergoing surgery to determine which dosing strategies most often achieves the admission target study values of 100-179 mg/dl.
There are no evidence-based guidelines for insulin glargine (Lantus) dosing in the perioperative setting. Insulin glargine provides peakless 24-hour coverage of basal insulin needs for people with both Type 1 and Type 2 diabetes. Insulin glargine may be used as the sole insulin or in combination with other rapid-acting insulin to achieve glycemic control.
Anesthesia literature recommends that blood sugar values on insulin-dependent patients be maintained between 120-180 mg/dl in most surgeries. Symptoms of low blood sugar are undetectable in anesthetized patients, and blood glucose is tested at least hourly. Since patients are still awake and alert toward hypoglycemic symptoms in the preoperative area, the admission target study values are 100-179 mg/dl. Glucose values greater than 200 mg/dl have been associated with increased rates of infection, and exacerbated complications if a major cardiovascular event happens.
Frequently insulin glargine is administered in the evening. Patients who are scheduled for surgery in the morning are asked not to eat or drink after midnight. Some endocrinology experts recommend that all or part of the patient's usual insulin glargine should be given to avoid high blood sugar; however, whenever insulin is given without food, the possibility of low blood sugar exists.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Patients in Group 1 will administer 80% of their usual insulin glargine dose. |
|
| 2 | Active Comparator | Group 2 patients will contact their own diabetes care physician and follow those recommendations for the dose. |
|
| 3 | Experimental | Group 3 patients will take 50%, 80%, or 100% of their usual insulin glargine dose. Which of those three percentages will be determined by the midpoint of the patient's usual self-reported fasting blood sugar (FBS) range and whether the patients is also taking a rapid-acting insulin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lantus | Drug | Patients in Group 1 will administer 80% of their usual insulin glargine dose. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary: Preoperative Fasting Blood Sugar Upon Arrival at the Hospital Prior to Surgery | Venous blood glucose values were obtained in the preoperative nursing unit. Blood glucose values were analyzed for achievement of target 100-179 mg/dl range and extended 80-249 mg/dl range. Analyses were by intention to treat. | Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tamra Dukatz, MSN, CRNA | Corewell Health East | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| William Beaumont Hospital | Royal Oak | Michigan | 48073 | United States | ||
| William Beaumont Hospital |
Subjects were stratified into groups (insulin glargine only group and insulin glargine plus bolus group) by the absence or presence of daily rapid-acting (or short-acting) insulin in regimen. The two groups were then randomized into Take 80%, Call Physician or Dose Table strategies. One subject was excluded from analysis due to eligibility error.
Recruitment at William Beaumont Heath System Royal Oak and Troy campuses commenced in October 2005 and was completed in September 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | Take 80% (Insulin Glargine Only Group) | Subjects were instructed to self-administer 80% of the usual insulin glargine dose on the evening before surgery. |
| FG001 | Call Physician (Insulin Glargine Only Group) | Subjects were instructed to call their own physician for the insulin glargine dose to administer the evening before surgery. |
| FG002 | Dose Table (Insulin Glargine Only Group) | Subjects were instructed to self-administer: (a) 50% of their usual insulin glargine if the midpoint of their usual self-reported fasting blood glucose value was < 150 mg/dl or (b) 80% of their usual insulin glargine if the midpoint of their usual self-reported fasting blood glucose range was > or = 150 mg/dl. |
| FG003 | Take 80% (Insulin Glargine Plus Bolus Group) | Subjects were instructed to self-administer 80% of the usual insulin glargine dose the evening before surgery |
| FG004 | Call Physician (Insulin Glargine Plus Bolus Group | Subjects were instructed to call their own physician for the insulin glargine dose to administer the evening before surgery. |
| FG005 | Dose Table (Insulin Glargine Plus Bolus Group) | Subjects were instructed to self-administer: (a) 80% of the usual insulin glargine dose if the midpoint of self-reported usual fasting blood glucose value was <150 mg/dl or (b) 100% of the usual insulin glargine dose if the midpoint of the self-reported usual fasting blood glucose range was > or = 150 mg/dl. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Take 80% (Insulin Glargine Only Group) | Subjects were instructed to self-administer 80% of the usual insulin glargine dose on the evening before surgery. |
| BG001 | Call Physician (Insulin Glargine Only Group) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Primary: Preoperative Fasting Blood Sugar Upon Arrival at the Hospital Prior to Surgery | Venous blood glucose values were obtained in the preoperative nursing unit. Blood glucose values were analyzed for achievement of target 100-179 mg/dl range and extended 80-249 mg/dl range. Analyses were by intention to treat. | Percentage of subjects that achieved preoperative blood glucose value of 100-179 mg/dl and 80-249 mg/dl. Analyses were by intention to treat. | Posted | Number | Percentage of subjects | Day 1 |
|
Adverse event data was collected for the preoperative period on the day of surgery. Severe hyperglycemia resulting in surgery cancellation and severe hypoglycemia resulting in loss of consciousness were defined as severe adverse events.
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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 | Take 80% (Insulin Glargine Only Group) | Subjects self-administered 80% of usual insulin glargine dose on the evening before surgery |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Severe Hyperglycemia resulting in surgery cancellation | Metabolism and nutrition disorders | Non-systematic Assessment | A subject with type 2 diabetes had inadvertently self-administered an overdose of rapid-acting insulin two days before surgery. Hypoglycemia treatment rendered and the basal insulin dose omitted that day leading to BG of 644 mg/dl on day of surgery. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Moderate Hypoglycemia | Metabolism and nutrition disorders | Non-systematic Assessment | Blood glucose value between 40-59 mg/dl in preoperative area, without loss of consciousness |
Limitations include use of point-of-care glucometers, which are less precise than central laboratory testing; estimated 75% power in the insulin glargine only group; and varying fasting lengths, usual glycemic control and surgery starting times.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tamra Dukatz, CRNA, MSN | Beaumont Health System | 248 992-4741 (pager) | tdukatz@beaumont.edu |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000069036 | Insulin Glargine |
| D007328 | Insulin |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Insulin | Other | Group 2 patients will contact their own diabetes care physician and follow those recommendations for the dose |
|
|
| Lantus | Drug | Group 3 patients will take 50%, 80%, or 100% of their usual insulin glargine dose. Which of those three percentages will be determined by the midpoint of the patient's usual self-reported fasting blood sugar (FBS) range and whether the patients is also taking a rapid-acting insulin. |
|
| Troy |
| Michigan |
| 48085 |
| United States |
Subjects were instructed to call their physician for the insulin glargine dose to administer the evening before surgery.
| BG002 | Dose Table (Insulin Glargine Only Group) | Subjects were instructed to self-administer: (a) 50% of their usual insulin glargine if the midpoint of their usual self-reported fasting blood glucose range was < 150 mg/dl or (b) 80% of their usual insulin glargine if the midpoint of their usual fasting blood glucose range was > or = 150 mg/dl. |
| BG003 | Take 80% (Insulin Glargine Plus Bolus Group) | Subjects were instructed to self-administer 80% of the usual insulin glargine dose the evening before surgery |
| BG004 | Call Physician (Insulin Glargine Plus Bolus Group | Subjects were instructed to call their own physician for the insulin glargine dose to administer the evening before surgery. |
| BG005 | Dose Table (Insulin Glargine Plus Bolus Group) | Subjects were instructed to self administer: (a) 80% of the usual insulin glargine dose if the midpoint of self-reported usual fasting blood glucose range was <150 mg/dl or (b) 100% of the usual insulin glargine dose if the midpoint of the self-reported usual fasting blood glucose range was > or = 150 mg/dl. |
| BG006 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Subjects called their own physicians for insulin glargine dose on the evening before surgery |
| OG002 | Dose Table (Insulin Glargine Only Group) | Subjects administered: (a) 50% of their usual insulin glargine dose if midpoint of usual self-reported fasting blood glucose range was <150 mg/dl or (b) 80% of usual insulin glargine dose if midpoint of usual self-reported fasting blood glucose range was > or = 150 mg/dl |
| OG003 | Take 80% (Insulin Glargine Plus Bolus Group) | Subjects self-administered 80% of the usual insulin glargine dose on the evening before surgery |
| OG004 | Call Physician (Insulin Glargine Plus Bolus Group | Subjects called their own physicians for the insulin glargine dose to administer on the evening before surgery |
| OG005 | Dose Table (Insulin Glargine Plus Bolus Group) | Subjects administered: (a) 80% of their usual insulin glargine dose if the midpoint of self-reported usual fasting blood glucose range was <150 mg/dl or (b) 100% of their usual insulin glargine dose if midpoint of self-reported usual fasting blood glucose ragne was > or = 150 mg/dl |
|
|
|
| 0 |
| 58 |
| 1 |
| 58 |
| EG001 | Call Physician (Insulin Glargine Only Group) | Subjects called physician for the insulin glargine dose on the evening before surgery. | 1 | 58 | 0 | 58 |
| EG002 | Dose Table (Insulin Glargine Only Group) | Subjects administered: (a) 50% of usual insulin glargine dose if midpoint of usual self-reported fasting blood glucose <150 mg/dl or (b) 80% of usual insulin glargine dose if midpoint of usual self-reported fasting blood glucose > or =150 mg/dl | 0 | 58 | 0 | 58 |
| EG003 | Take 80% (Insuling Glargine Plus Bolus Group) | Subjects self-administered 80% of usual insulin glargine dose on the evening before surgery | 0 | 75 | 1 | 75 |
| EG004 | Call Physician (Insulin Glargine Plus Bolus Group) | Subjects called physician for the insulin glargine dose to administer on the evening before surgery. | 0 | 76 | 0 | 76 |
| EG005 | Dose Table (Insulin Glargine Plus Bolus Group) | Subjects administered: (a) 80% of usual insulin glargine if midpoint of usual self-reported fasting blood glucose was <150 mg/dl or (b) 100% of usual insulin glargine dose if midpoint of usual self-reported fasting blood glucose was < or =150 mg/dl. | 0 | 76 | 1 | 76 |
|
|
| Severe hyperglycemia without surgery cancellation | Metabolism and nutrition disorders | Non-systematic Assessment | Blood glucose >400 mg/dl in preoperative area |
|
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| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011384 | Proinsulin |