A Phase 4 interventional study of Lantus and Insulin in Diabetes and Surgery, sponsored by Tamra Dukatz. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-12-03.
Sponsored by Tamra Dukatz · Phase 4, Interventional, and Treatment
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 402 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
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Exclusion Criteria:
Patients in Group 1 will administer 80% of their usual insulin glargine dose.
Drug: Lantus
Group 2 patients will contact their own diabetes care physician and follow those recommendations for the dose.
Other: Insulin
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.
Drug: Lantus
Patients in Group 1 will administer 80% of their usual insulin glargine dose.
Also known as: Lantus, Insulin
Group 2 patients will contact their own diabetes care physician and follow those recommendations for the dose
Also known as: As directed by regular physician
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.
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
Recruitment at William Beaumont Heath System Royal Oak and Troy campuses commenced in October 2005 and was completed in September 2008.
| Milestone | 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) |
|---|---|---|---|---|---|---|
| Started | 58 | 58 | 58 | 76 | 76 | 76 |
| Completed | 58 | 58 | 58 | 75 | 76 | 76 |
| Not completed | 0 | 0 | 0 | 1 | 0 | 0 |
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 | 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) |
|---|---|---|---|---|---|---|
| Achievement of 100-179 mg/dl | 58.6 | 72.4 | 74.1 | 58.7 | 52.6 | 63.2 |
| Achievement of 80-249 mg/dl | 89.7 | 89.7 | 98.3 | 81.3 | 81.6 | 93.4 |
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Take 80% (Insulin Glargine Only Group) | — | 0/58 (0%) | 1/58 (1.7%) |
| Call Physician (Insulin Glargine Only Group) | — | 1/58 (1.7%) | 0/58 (0%) |
| Dose Table (Insulin Glargine Only Group) | — | 0/58 (0%) | 0/58 (0%) |
| Take 80% (Insuling Glargine Plus Bolus Group) | — | 0/75 (0%) | 1/75 (1.3%) |
| Call Physician (Insulin Glargine Plus Bolus Group) | — | 0/76 (0%) | 0/76 (0%) |
| Dose Table (Insulin Glargine Plus Bolus Group) | — | 0/76 (0%) | 1/76 (1.3%) |
| Event | Take 80% (Insulin Glargine Only Group) | Call Physician (Insulin Glargine Only Group) | Dose Table (Insulin Glargine Only Group) | Take 80% (Insuling Glargine Plus Bolus Group) | Call Physician (Insulin Glargine Plus Bolus Group) | Dose Table (Insulin Glargine Plus Bolus Group) |
|---|---|---|---|---|---|---|
| Severe Hyperglycemia resulting in surgery cancellationMetabolism and nutrition disorders | 0/58 | 1/58 | 0/58 | 0/75 | 0/76 | 0/76 |
| Event | Take 80% (Insulin Glargine Only Group) | Call Physician (Insulin Glargine Only Group) | Dose Table (Insulin Glargine Only Group) | Take 80% (Insuling Glargine Plus Bolus Group) | Call Physician (Insulin Glargine Plus Bolus Group) | Dose Table (Insulin Glargine Plus Bolus Group) |
|---|---|---|---|---|---|---|
| Moderate HypoglycemiaMetabolism and nutrition disorders | 1/58 | 0/58 | 0/58 | 0/75 | 0/76 | 1/76 |
| Severe hyperglycemia without surgery cancellationMetabolism and nutrition disorders | 0/58 | 0/58 | 0/58 | 1/75 | 0/76 | 0/76 |
| Age, Categorical(Participants) | 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 |
|---|---|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 37 | 34 | 31 | 52 | 53 | 52 | 259 |
| >=65 years | 21 | 24 | 27 | 23 | 23 | 24 | 142 |
| Age Continuous(years) | 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 |
|---|---|---|---|---|---|---|---|
| Mean | 60.1 ± 10.0 | 61.5 ± 11.4 | 63.1 ± 11.6 | 55.8 ± 15.9 | 58.4 ± 12.0 | 57.3 ± 13.3 | 59.1 ± 12.5 |
| Sex: Female, Male(Participants) | 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 |
|---|---|---|---|---|---|---|---|
| Female | 30 | 27 | 28 | 43 | 41 | 38 | 207 |
| Male | 28 | 31 | 30 | 32 | 35 | 38 | 194 |
| Region of Enrollment(participants) | 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 |
|---|---|---|---|---|---|---|---|
| United States | 58 | 58 | 58 | 75 | 76 | 76 | 401 |
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