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Clinical Pharmacy Coordinator, Pharmacy Department, Medical Center of Plano, Plano, TX
Critical Care Clinical Nurse Specialist, Critical Care Unit, Medical Center of Plano
Pharmacy Intern, Pharmacy Department, Medical Center of Plano
Pharmacy Intern, Pharmacy Department, Medical Center of Plano
Pharmacy Intern, Pharmacy Department, Medical Center of Plano
Pharmacy Intern, Pharmacy Department, Medical Center of Plano
Analyst/Biostatistician, Clinical Services Group, Hospital Corporation of America, Nashville, TN
Chief Endocrinologist, Endocrinology Department, Medical Center of Plano
Reprints: Dr. Patel, Pharmacy Department, Medical Center of Plano, 3901 W. 15th St., Plano, TX 75075, fax 972/519-1239, Gita.patel{at}hcahealthcare.com
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Abstract |
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OBJECTIVE: To compare traditional sliding scale (SS) with a tight glycemic control (TC) algorithm. The primary endpoint was the percentage of total blood glucose measurements in the target range of 80–150 mg/dL. The secondary endpoint evaluated was safety, defined as percentage of all blood glucose measurements that were 0–60 mg/dL.
METHODS: A 1-year, retrospective analysis from June 1, 2007, to May 31, 2008, was performed evaluating all inpatients with hyperglycemia within the first 48 hours of admission to the Medical Center of Plano, Plano, TX. A cohort of patients managed with SS (n =121) was compared with those treated with TC (n = 210). Patients on SS insulin received a traditional SS regimen with regular insulin or insulin aspart based on physician preference.
RESULTS: Demographics and comorbidities were similar between the 2 groups; however, the TC cohort was younger (64.8 ± 14.1 vs 70.8 ± 13.7 y; p < 0.001). There were more persons with type 2 diabetes mellitus in the TC cohort (81.9%) versus the SS cohort (60.3%; p < 0.001). In the TC cohort, 42.9% of blood glucose measurements were in the target range of 80–150 mg/dL compared with 30.6% of the measurements in the SS cohort (p < 0.001). Regarding safety, 2% of blood glucose measurements of the TC cohort were in the range of 0–60 mg/dL versus 0.3% of the SS cohort (p < 0.001). No clinical sequelae of hypoglycemia were observed. Patients achieved more blood glucose measurements in the target range when treated with TC versus SS insulin, without regard to prior history of diabetes.
CONCLUSIONS: Patients treated with TC experienced more blood glucose measurements in the target range as compared with patients treated with SS with relatively low hypoglycemia rates.
Key Words: diabetes mellitus, insulin, noncritically ill, sliding scale
Published Online, October 13, 2009. www.theannals.com, DOI 10.1345/aph.1M331
.4
These proinflammatory mediators can worsen disease states such as sepsis,
heart failure, and acute thrombosis and can contribute to the progression of
atherosclerosis.5
Finally, ischemic events can be worsened by acute hyperglycemia since
hyperglycemia increases platelet activation, fibrinogen, and C-reactive
protein.6
Therefore, effects of acute hyperglycemia can cause poor outcomes in a myriad
of disease states. The American Diabetes Association (ADA) issued guidelines regarding the optimal blood glucose ranges for hospitalized patients in 2007.7 The ADA recommended maintaining the random blood glucose level as close to 110 mg/dL as possible in critically ill patients. In hospitalized, noncritically ill patients, the recommended fasting blood glucose range had been 90–130 mg/dL. Recently, the ADA and the American Association of Clinical Endocrinologists released updated guidelines recommending a target range of 140–180 mg/dL for the critically ill, with some patients benefitting from a range of 110–180 mg/dL.8 In the noncritically ill, the guidelines recommend a premeal blood glucose level of less than 140 mg/dL in conjunction with random blood glucose values of less than 180 mg/dL. However, there are patients who could benefit from a lower range. These ranges cannot be achieved with traditional sliding scale (SS) insulin treatment.9
Many clinical outcome studies have been done in critically ill patients to evaluate the effectiveness of various algorithms. The 2 most acclaimed trials were done by van den Berghe et al. in both surgical10 and medical11 intensive care units (ICUs). In critically ill, mechanically ventilated, surgical patients, in-hospital mortality was reduced when a blood glucose range of 80–100 mg/dL was maintained. In medical ICU patients, a reduction in mortality with the tight glycemic control (TC) algorithm was seen only in patients who were in the ICU for at least 3 days. Both studies used an intravenous insulin infusion with concomitant parenteral/enteral feeding. In contrast, the NICE-SUGAR trial reported an increase in mortality in the critically ill when a glucose range of 80–108 mg/dL was targeted.12 However, large, publicized trials such as these have not been done in noncritically ill patients. Also, it is difficult to find functional algorithms in the literature. Although it is widely accepted that SS treatment is not aggressive enough to achieve the blood glucose measurements recommended by the ADA, there have not been any large trials examining the clinical effect of subcutaneous TC algorithms.
The Medical Center of Plano instituted intravenous TC for the critically ill in 2004 and a subcutaneous TC algorithm for the noncritically ill in 2006 (Appendix I, available at: www.hwbooks.com/pdf/appendices/M331.pdf). A 1-year retrospective evaluation was performed comparing patients receiving SS versus those receiving TC. Patients on SS insulin received a traditional SS with regular insulin or insulin aspart, whereas patients on TC received a basal/bolus insulin regimen with a long-acting insulin (insulin glargine) and a short-acting insulin (regular insulin or insulin aspart). The goal of this study was to evaluate the clinical efficacy and safety associated with a TC algorithm. The primary endpoint was the percentage of blood glucose measurements in the 80–150 mg/dL range. This range was chosen because published basal/bolus regimens aimed for this range versus the recommended 90–130 mg/dL due to concerns of hypoglycemia.13,14 Wesorick et al.14 acknowledged that the previous 90–130 mg/dL goal was possibly too stringent and institutions needed to arrive at a consensus for the target blood glucose range. The consensus at our institution was 80–150 mg/dL. The secondary endpoint was an examination of hypoglycemia (0–60 mg/dL) rates.
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Methods |
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Exclusion criteria consisted of:
The SS regimen was based on physician preference and was not standardized. The TC regimen was a hospital-approved algorithm (Appendix I). The TC algorithm consisted of a basal-bolus regimen. A total daily dose (TDD) of insulin was determined based on patient-specific parameters. The TDD was then divided into a long-acting insulin (insulin glargine [0.4 x TDD]) and a short-acting insulin (insulin aspart [0.2 x TDD] or regular insulin [0.15 x TDD]). A target range of 80–150 mg/dL was established in an effort to achieve tighter control of blood glucose without risking high rates of hypoglycemia. All blood glucose measurements were determined by point-of-care testing.
Data collected included demographics, comorbidities, admitting and discharge diagnosis, medications for blood glucose management, patient location pre- and postdischarge, hemoglobin A1c (A1C), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C) on admission and discharge; blood glucose measurements; final blood glucose measurement on discharge; and amount of insulin administered. Clinical sequela for hypoglycemia was defined as a clinical situation that required more than oral glucose or 50 mL of 50% dextrose in water. Data were collected by 4 of the authors and then verified for accuracy by the remaining authors.
Continuous variables were compared by 2-sample Student's t-test
and the Mann-Whitney U test. Categorical variables were compared by
the 
2 test and the Fisher's exact test as appropriate
based on data. For all analyses, p less than 0.05 was considered significant
for 2-tailed tests. All calculations were performed using SPSS version 11.0
(SPSS Inc., Chicago, IL).
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Results |
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Medications taken prior to admission were similar between the 2 groups (Table 1). However, more TC patients were taking insulin and oral hypoglycemics on admission as compared with SS patients (Table 1). Admission A1C was higher in the TC group compared with that in SS patients (8.2% vs 6%; p < 0.001). LDL-C, HDL-C, and triglyceride levels were all similar on admission.
Blood glucose measurements were dissimilar between the 2 groups. The mean of initial blood glucose measurements was higher in the TC group (206.3 mg/dL) versus the SS group (160.6 mg/dL; p < 0.001) (Table 2). For the primary endpoint, TC patients had more total blood glucose measurements in the target blood glucose range of 80–150 mg/dL (42.9% of all measurements of patients in TC group) versus the measurements in the SS group (30.6%; p < 0.001). SS patients had more total blood glucose measurements above the target range (blood glucose >150 mg/dL; 68.3% vs 50.8%; p < 0.001). For the secondary endpoint, TC patients had more total blood glucose measurements that were less than 60 mg/dL (2% vs 0.3%; p < 0.001). No clinical sequelae were seen from the cases of hypoglycemia. More TC patients were discharged with the blood glucose measurement in the target range of 80–150 mg/dL (51%) as opposed to 25.6% of SS patients (p < 0.001), whereas more SS patients were discharged with a blood glucose level greater than 150 mg/dL (Table 3). Differences in medications on discharge were also noted (Table 3). TC patients also received more units of insulin and more injections than SS patients (Table 4).
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A subset analysis was performed on patients with or without diabetes. Patients with diabetes using TC had a lower overall mean of total blood glucose measurements (180.4 mg/dL) versus those using SS (187 mg/dL; p = 0.003). They also had a lower mean blood glucose level on discharge (170 vs 202.1 mg/dL; p < 0.001) (Table 5). In patients without diabetes, a higher percentage of TC total blood glucose measurements was in the target range of 80–150 mg/dL (58.3%) versus SS total blood glucose measurements (34.1%; p < 0.001). On the other hand, there was a higher frequency of total blood glucose measurements greater than 150 mg/dL in the SS patients (Table 5). Blood glucose measurements were also stratified by patient type based on discharge diagnosis (Table 5).
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Discussion |
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The data revealed that a higher percentage of patients on TC were discharged on pharmacotherapy for hyperglycemia, particularly basal insulin products, as compared with those on SS. This may be due to the fact that TC patients were being treated more aggressively in the hospital as compared with those being treated with SS and also because more of the TC patients had diabetes.
Limitations of the study include the small sample size and the limited availability of data for analysis. Also, use of SS versus TC was based on physician preference, so this could inherently inject bias into the study. This bias may have been reflected in the fact that the mean starting blood glucose level was higher in the TC group.
Overall, the TC algorithm provided improved control of blood glucose as compared with SS without compromising clinical outcome. Retrospective or prospective data comparing SS with an intense TC regimen are not currently available in the literature. A double-blind, randomized trial would be ideal to provide a definitive comparison of these treatment modalities; however, our study provides a foundation for future research.
A subcutaneous TC algorithm can effectively and safely control blood glucose as compared with traditional SS regimens.
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