Diabetes, Surgery
Conditions
Keywords
Diabetes, Insulin Glargine, Surgery
Brief summary
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.
Detailed description
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. 1. Patients in Group 1 will administer 80% of their usual insulin glargine dose. 2. Group 2 patients will contact their own diabetes care physician and follow those recommendations for the dose. 3. 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.
Interventions
DRUGLantus
Patients in Group 1 will administer 80% of their usual insulin glargine dose.
OTHERInsulin
Group 2 patients will contact their own diabetes care physician and follow those recommendations for the dose
Sponsors
Sanofi
Tamra Dukatz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Scheduled for Surgical Procedure * Self Management of Diabetes * Currently on Evening Insulin Glargine prescribed by Primary Care Physician * Age 18 or over * Able to Communicate Clearly over the Phone * Pre-screened by Anesthesia Department \> 48 hours prior to Surgery
Exclusion criteria
* On Glucocorticoid Medication * On Insulin Glargine Dual Dosing or Sliding Scale Regimen * History of Hypoglycemia Unawareness * Pregnancy or Lactating Female * On Insulin Glargine for \< 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary: Preoperative Fasting Blood Sugar Upon Arrival at the Hospital Prior to Surgery | Day 1 | 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment at William Beaumont Heath System Royal Oak and Troy campuses commenced in October 2005 and was completed in September 2008.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Take 80% (Insulin Glargine Only Group) Subjects were instructed to self-administer 80% of the usual insulin glargine dose on the evening before surgery. | 58 |
| Call Physician (Insulin Glargine Only Group) Subjects were instructed to call their physician for the insulin glargine dose to administer the evening before surgery. | 58 |
| 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. | 58 |
| Take 80% (Insulin Glargine Plus Bolus Group) Subjects were instructed to self-administer 80% of the usual insulin glargine dose the evening before surgery | 75 |
| 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. | 76 |
| 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. | 76 |
| Total | 401 |
Baseline characteristics
| Characteristic | Take 80% (Insulin Glargine Only Group) | Call Physician (Insulin Glargine Only Group) | Dose Table (Insulin Glargine Only Group) | Take 80% (Insulin Glargine Plus Bolus Group) | Call Physician (Insulin Glargine Plus Bolus Group | Dose Table (Insulin Glargine Plus Bolus Group) | Total |
|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 21 Participants | 24 Participants | 27 Participants | 23 Participants | 23 Participants | 24 Participants | 142 Participants |
| Age, Categorical Between 18 and 65 years | 37 Participants | 34 Participants | 31 Participants | 52 Participants | 53 Participants | 52 Participants | 259 Participants |
| Age Continuous | 60.1 years STANDARD_DEVIATION 10 | 61.5 years STANDARD_DEVIATION 11.4 | 63.1 years STANDARD_DEVIATION 11.6 | 55.8 years STANDARD_DEVIATION 15.9 | 58.4 years STANDARD_DEVIATION 12 | 57.3 years STANDARD_DEVIATION 13.3 | 59.1 years STANDARD_DEVIATION 12.5 |
| Region of Enrollment United States | 58 participants | 58 participants | 58 participants | 75 participants | 76 participants | 76 participants | 401 participants |
| Sex: Female, Male Female | 30 Participants | 27 Participants | 28 Participants | 43 Participants | 41 Participants | 38 Participants | 207 Participants |
| Sex: Female, Male Male | 28 Participants | 31 Participants | 30 Participants | 32 Participants | 35 Participants | 38 Participants | 194 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 1 / 58 | 0 / 58 | 0 / 58 | 1 / 75 | 0 / 76 | 1 / 76 |
| serious Total, serious adverse events | 0 / 58 | 1 / 58 | 0 / 58 | 0 / 75 | 0 / 76 | 0 / 76 |
Outcome results
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.
Time frame: Day 1
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Take 80% (Insulin Glargine Only Group) | Primary: Preoperative Fasting Blood Sugar Upon Arrival at the Hospital Prior to Surgery | Achievement of 100-179 mg/dl | 58.6 Percentage of subjects |
| Take 80% (Insulin Glargine Only Group) | Primary: Preoperative Fasting Blood Sugar Upon Arrival at the Hospital Prior to Surgery | Achievement of 80-249 mg/dl | 89.7 Percentage of subjects |
| Call Physician (Insulin Glargine Only Group) | Primary: Preoperative Fasting Blood Sugar Upon Arrival at the Hospital Prior to Surgery | Achievement of 100-179 mg/dl | 72.4 Percentage of subjects |
| Call Physician (Insulin Glargine Only Group) | Primary: Preoperative Fasting Blood Sugar Upon Arrival at the Hospital Prior to Surgery | Achievement of 80-249 mg/dl | 89.7 Percentage of subjects |
| Dose Table (Insulin Glargine Only Group) | Primary: Preoperative Fasting Blood Sugar Upon Arrival at the Hospital Prior to Surgery | Achievement of 100-179 mg/dl | 74.1 Percentage of subjects |
| Dose Table (Insulin Glargine Only Group) | Primary: Preoperative Fasting Blood Sugar Upon Arrival at the Hospital Prior to Surgery | Achievement of 80-249 mg/dl | 98.3 Percentage of subjects |
| Take 80% (Insulin Glargine Plus Bolus Group) | Primary: Preoperative Fasting Blood Sugar Upon Arrival at the Hospital Prior to Surgery | Achievement of 100-179 mg/dl | 58.7 Percentage of subjects |
| Take 80% (Insulin Glargine Plus Bolus Group) | Primary: Preoperative Fasting Blood Sugar Upon Arrival at the Hospital Prior to Surgery | Achievement of 80-249 mg/dl | 81.3 Percentage of subjects |
| Call Physician (Insulin Glargine Plus Bolus Group | Primary: Preoperative Fasting Blood Sugar Upon Arrival at the Hospital Prior to Surgery | Achievement of 100-179 mg/dl | 52.6 Percentage of subjects |
| Call Physician (Insulin Glargine Plus Bolus Group | Primary: Preoperative Fasting Blood Sugar Upon Arrival at the Hospital Prior to Surgery | Achievement of 80-249 mg/dl | 81.6 Percentage of subjects |
| Dose Table (Insulin Glargine Plus Bolus Group) | Primary: Preoperative Fasting Blood Sugar Upon Arrival at the Hospital Prior to Surgery | Achievement of 100-179 mg/dl | 63.2 Percentage of subjects |
| Dose Table (Insulin Glargine Plus Bolus Group) | Primary: Preoperative Fasting Blood Sugar Upon Arrival at the Hospital Prior to Surgery | Achievement of 80-249 mg/dl | 93.4 Percentage of subjects |
Comparison: Comparison for Target Blood Glucose Achievement of 100-179 mg/dlp-value: 0.332Chi-squared
Comparison: Comparison for Target Achievement of blood glucose values of 100-179 mg/dlp-value: 0.294Chi-squared
Comparison: Comparison of Achievement of blood glucose values of 80-249 mg/dlp-value: 0.162Chi-squared
Comparison: Comparison of Achievement of blood glucose values of 80-249 mg/dl.p-value: 0.031Chi-squared