Type 2 Diabetes, Inpatient Hyperglycemia
Conditions
Keywords
diabetes, post-op complications, inpatient hyperglycemia
Brief summary
High blood glucose levels in surgical patients with diabetes are associated with increased risk of medical complications and death. Improved glucose control with insulin injections may improve clinical outcome and prevent some of the hospital complications. In patients who have undergone surgery, high blood glucose increases the risk of wound infection, kidney failure and death. It is not known; however, what is the best insulin regimen in patients who will undergo surgery. The use of repeated injections of regular insulin is commonly used for glucose control in hospitalized patients with diabetes. Recently, the combination of Lantus® and Apidra® insulins has been shown to improve glucose control with lower rate of hypoglycemia (low blood sugar). We hypothesize that in patients with type 2 diabetes admitted to general surgery wards, treatment with once daily glargine (Lantus) plus supplemental glulisine insulin (Apidra®) will produce better glycemic control and a lower rate of hospital complications than treatment with regular insulin per sliding scale (SSRI). The present study aims to determine which insulin treatment is best for glucose control in hospitalized patients with diabetes. Glargine and glulisine insulins are approved for use in the treatment of patients with diabetes by the FDA. Subjects included in the study will have type 2 diabetes and be admitted to Grady Memorial Hospital, Veterans Administration Medical Center, and Emory University Hospital, Atlanta, Georgia. A total of \ 94 patients will be recruited at each institution. A post-hoc cost analysis of hospitalization costs and charges of the Rabbit surgery trial will be completed in order to determine differences in hospitalization cost between basal bolus insulin and SSI regimen.
Interventions
DRUGInsulin glargine
Insulin glargine once daily SQ
DRUGRegular insulin
Sliding scale regular insulin SQ four-times daily before meals or every 6 hours if patient NPO
DRUGInsulin glulisine
scheduled glulisine given SQ at mealtime TID; none given if patient NPO
Sponsors
Sanofi
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Males or females between the ages of 18 and 80 years admitted to a general surgery service. 2. Patients admitted for non-cardiac elective or emergency surgery or trauma. 3. A known history of type 2 diabetes mellitus \> 3 months, receiving either diet alone or any combination of oral antidiabetic agents (sulfonylureas, metformin, thiazolidinediones). 4. Subjects must have an admission blood glucose \> 140 mg and \< 400 mg/dL without laboratory evidence of diabetic ketoacidosis (serum bicarbonate \< 18 mEq/L or positive serum or urinary ketones).
Exclusion criteria
1. Subjects with increased blood glucose concentration, but without a known history of diabetes (stress hyperglycemia). 2. Subjects with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state, or ketonuria. 3. Acute critical illness or CABG surgery expected to require prolonged admission to a critical care unit (ICU, CCU, SICU, Neuro ICU). 4. Patients with clinically relevant hepatic disease or impaired renal function, as shown by a serum creatinine ≥ 3.5 mg/dl. 5. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study. 6. Female subjects are pregnant or breast feeding at time of enrollment into the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Blood Glucose Concentration | hospital stay days 2-10 | blood glucose concentration in the intervention groups after second day of treatment to up to 10 days of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| # Participants With Hypoglycemic Events | hospital stay days 2-10 | number of participants in the treatment arms with of hypoglycemic events (\< 70 mg/dl) |
Countries
United States
Participant flow
Recruitment details
Enrolled patients with a BG 140-400 mg/dL with DM for more than 3 months,aged 18-80 yo, treated with diet alone, any combination of oral antidiabetic agents, or lowdose insulin in 2008-2009. Study was conducted at Grady Memorial Hospital,Emory University Hospitaland the Veterans Administration Medical Center.
Pre-assignment details
Exclusion criteria included hyperglycemia without a known history of diabetes, cardiac surgery, clinically relevant hepatic disease or impaired renal function (serum creatinine ≥3.0 mg/dL), history of diabetic ketoacidosis (20), pregnancy, and any mental condition rendering the subject unable to give informed consent.
Participants by arm
| Arm | Count |
|---|---|
| Basal Bolus Glargine and rapid-acting mealtime insulin plus supplemental glulisine | 104 |
| SSRI Sliding scale regular insulin four-times daily. | 107 |
| Total | 211 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | < 24 hours of insulin treatment | 8 | 6 |
| Overall Study | cancelled surgery | 1 | 1 |
| Overall Study | continuous insulin infusion during TPN | 2 | 1 |
| Overall Study | Withdrawal by Subject | 3 | 1 |
Baseline characteristics
| Characteristic | SSRI | Basal Bolus | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 3 Participants | 8 Participants |
| Age, Categorical Between 18 and 65 years | 102 Participants | 101 Participants | 203 Participants |
| Age, Continuous | 57 years STANDARD_DEVIATION 10 | 58 years STANDARD_DEVIATION 12 | 58 years STANDARD_DEVIATION 11 |
| Region of Enrollment United States | 107 participants | 104 participants | 211 participants |
| Sex: Female, Male Female | 54 Participants | 50 Participants | 104 Participants |
| Sex: Female, Male Male | 53 Participants | 54 Participants | 107 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 104 | 0 / 107 |
| serious Total, serious adverse events | 24 / 104 | 5 / 107 |
Outcome results
Primary
Mean Blood Glucose Concentration
blood glucose concentration in the intervention groups after second day of treatment to up to 10 days of treatment
Time frame: hospital stay days 2-10
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Basal Bolus | Mean Blood Glucose Concentration | 145 mg/dl | Standard Deviation 32 |
| SSRI | Mean Blood Glucose Concentration | 172 mg/dl | Standard Deviation 46 |
Secondary
# Participants With Hypoglycemic Events
number of participants in the treatment arms with of hypoglycemic events (\< 70 mg/dl)
Time frame: hospital stay days 2-10
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Basal Bolus | # Participants With Hypoglycemic Events | 24 participants |
| SSRI | # Participants With Hypoglycemic Events | 5 participants |