Evaluation of the effectiveness regarding the participation of pharmacists in perioperative blood glucose management via the iGMS: a pilot RCT

Subjects

From September 2019 to April 2020, this study included patients with T2DM who underwent elective surgery in orthopedic, urologic, general, cardiovascular, cardiothoracic, and gynecologic departments at the Affiliated Hospital of Jiangnan University (Original Third Hospital). According to the method of random number table, a total of 300 participants were divided into control group (101 male and 49 female) and intervention group (94 male and 56 female). Inclusion criteria: (1) meet the diagnostic criteria for T2DM given by the world health organization (WHO) in 1999; (2) meet the indications for surgery; (3) patients and their families give informed consent and can effectively cooperate with the medical professionals. Exclusion criteria: (1) patients with severe respiratory, cardiovascular, or hepatic or kidney diseases; (2) patients with unclear consciousness or communication disabilities; (3) individuals with neurological or psychiatric disorders; (4) patients and their families unable to comprehend the work of blood glucose management team; (5) Minors, pregnant or lactating women; (6) patients with prolonged postoperative fasting and use of nutrient preparations; (7) patients with a preoperative or postoperative management duration shorter than 3 days.

Model of blood glucose management

The traditional blood glucose management model was performed for the control group of patients. The mobile blood glucose detector was used to measure capillary blood glucose of patients. The patients with T2DM who had been diagnosed, the starting frequency of blood glucose monitoring was 4 times daily. The attending physician invited an endocrinology specialist for a consultation when the FPG ≥ 7.0 mmol/L or PPG ≥ 11.1 mmol/L. The consulting physician formulated a treatment regimen according to the glycemic record sheet and other examination results, and the attending physician followed the medical advice of the consulting physician.

For patients of the intervention group, the clinical pharmacist would manage the blood glucose of the patients via the informatized glucose management system (iGMS, Beijing Huayi Jingdian Biotechnology Co.). A clinical smart glucose meter known as the GLUPAD is applied to monitor the blood glucose levels of patients, and in the same way, the nurse can use the GLUPAD to identify and confirm the patient at the bedside of the patient via a wrist barcode before measuring the blood glucose. After the measurement of blood glucose, the data from the GLUPAD can be automatically synchronized to the iGMS system for storage, archiving and analysis. Clinical pharmacists can access medical history information, medication records, property of disease, dietary status, surgical procedures, bio-chemical outcomes, graphical glycemic fluctuations at various times during the hospitalization, and notes on major glycemic events via the iGMS. Thresholds for hyperglycemia and hypoglycemia are established, and the iGMS is equipped with a reminder function once the blood glucose uploaded is below or above the defined thresholds.

Clinical pharmacists were engaged in the whole process of the blood glucose management for perioperative patients under the guidance of expert consensus. Detailed duties include: (1) information collection before management, and establishing a blood glucose management form for patients, registering information about the treatment of patients and daily blood glucose monitoring level; (2) bedside checkups daily, medication treatment management, and providing guidance to patients about medication, diet, and exercise education; (3) participating in the determination of the date for surgery and type of surgery for patients, specifying the blood glucose control target for patients before surgery, and also evaluating the current level of blood glucose control to provide doctors with suggestions for medication; (4) monitoring of adverse drug reactions during treatment; (5) formulation of the management program and criteria; (6) creating strategies to lower blood glucose for patients who will be discharged from the hospital and providing education on medications. The specific management process is shown in Fig. 1.

Responsibilities of clinical pharmacists

Clinical pharmacists are responsible for monitoring the blood glucose data of perioperative patients based on the iGMS. They are actively involved in the entire process of perioperative blood glucose management, guided by evidence-based medicine such as expert consensus and clinical guidelines. Clinical pharmacists participate in blood glucose management through the following main measures: (1) Clinical pharmacists begin by collecting information, conducting pharmaceutical interviews, and performing pharmaceutical assessments. They establish blood glucose management profiles for patients, record medication histories, and annotate drugs that can affect blood glucose. (2) Clinical pharmacists provide pharmaceutical care for patients with abnormal blood glucose levels. This includes tracking blood glucose monitoring results, reviewing prescriptions, and monitoring for adverse reactions using iGMS. If there is poor blood glucose control or changes in the patient’s condition during treatment, clinical pharmacists provide feedback to the physicians to make timely adjustments. (3) Clinical pharmacists, considering the patient’s individual condition, develop personalized management plans and guidelines for patients with abnormal blood glucose levels. (4) Clinical pharmacists participate in discussions about the patient’s surgical date and type of surgery. They also contribute to establishing preoperative blood glucose control goals. Additionally, they assess the patient’s current blood glucose control level and provide recommendations to physicians for adjusting medication treatment plans. (5) Clinical pharmacists offer medication guidance during the patient’s hospital stay and medication education upon discharge. This includes instructions on medication administration, prevention, and management of low blood sugar, among other topics.

Fig. 1figure 1

Specific management flows of two groups patients with T2DM. Abbreviations used: iGMS, informatized glucose management system; ADRs, adverse drug reactions

Collection of clinical index

Detailed history taking and physical examination were performed for each patient, and information on age, gender, height (in meters), weight (in kilograms), waist and hip circumferences (in centimeters), duration of T2DM, history of smoking and alcohol consumption, diabetic retinopathy (DR), dosage of insulin, systolic blood pressure (SBP), diastolic blood pressure (DBP), fasting plasma glucose (FPG), and postprandial plasma glucose (PPG) were recorded. Serum lipids including total cholesterol (TC), triglyceride (TG), low-density lipoprotein (LDL-c), and high-density lipoprotein (HDL-c) were detected using a Roche Cobas8000 analyzer (Roche, Basel, Switzerland) with standard laboratory methods. The levels of C-peptide were measured by an electrochemiluminescence assay (Roche, Shanghai, China). The amounts of glycated hemogolobin (HbA1c) were determined using the Variant II Turbo system (Bio-Rad, America). The general anthropometric parameters such as height, weight, waist circumference and hip circumference were measured in the morning on an empty stomach. Waist circumference was measured at the midpoint of the line connecting the lower rib cage and the skeleton, and hip circumference was measured at the level of the greater trochanter of the femur. Body index (BMI) and waist to hip ratio (WHR) were calculated. BMI = body weight (kg)/height (m)2, WHR = waist circumference (cm)/hip circumference (cm). Islet function was stratified into 3 grades of mild, moderate, and severe abnormalities according to the ratio of peak C-peptide to fasting C-peptide [22].

Grading criteria for surgery

(1) Level I: various surgeries with low technical difficulty, simple surgical procedures, and low risk. (2) Level II: winter surgeries with average technical difficulty, uncomplicated surgical procedures, and moderate risk, (3) Level III: various surgeries with a relatively high level of technical difficulty, complicated surgical procedures, and moderate risk. (4) Level IV: various surgeries with high technical difficulty, complex surgical procedures, and high degree of risk.

Evaluation indicators of effectiveness

(1) Preoperative glycemic compliance of patients: according to the blood glucose management control goals for perioperative patients recommended by the Chinese Expert Consensus on Glycemic Management in Hospitalized Patients [23], the preoperative blood glucose compliance rate was the percentage of the number of patients meeting the standard to the total number of patients; (2) preoperative waiting time was the time from the time patients received blood glucose management to the date of the operation; and (3) the number of days of inpatient.

Indicators of adverse events

(1) Incidence of hypoglycemia: blood glucose ≤ 3.9 mmol/L is the judgment standard for hypoglycemic events, and the percentage of the number of patients with one or more hypoglycemic events to the total number of patients; (2) Incidence of hyperglycemia: the percentage of the number of patients with FPG > 7.8 mmol/L, and PPG or random blood glucose > 10.0 mmol/L to the total number of patients. (3) Determination of postoperative infection: the patients showed elevated body temperature, abnormal elevation of blood routine and C-reactive protein test at least 2 times after surgery. In addition, a comprehensive evaluation was made by combining the description of the local condition of the incision in the medical record with the diagnosis of infection at the operation area and the healing status of the incision. The percentage of the number of individuals meeting the above phenomena to the total number of patients is the incidence of postoperative infection.

Statistical analysis

All data were expressed as mean ± standard deviation (Mean ± SD) or percentage as appropriate. Statistical analyses were performed using SPSS software (version 13.0 for Windows; SPSS Inc., Chicago, IL, USA). The paired t-test was used for intra-group comparisons of before and after management. The two-sample t-test was used to compare the characteristics between control group and intervention group. The Chi-square test was used for comparisons of counting data. Two-sided tests were used for all analyses, and P < 0.05 indicated statistically significant.

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