Clinical Evaluation of OneTouch Diabetes Management Software System in Patients with Type 2 Diabetes Mellitus
Article information
Abstract
Background
OneTouch Diabetes Management Software (OTDMS) is an efficient way to track and monitor the blood glucose level. It is possible to download data from the OneTouch Ultra via the meter's data port, and to transform the numbers of the blood glucose level into a graph, a chart, or statistics. The objectives of this study were to evaluate whether the use of OTDMS in consultation hours would improve patients' knowledge of diabetes mellitus (DM), compliance, satisfaction with doctor and medical treatment, doctor-patient reliability, and glucose control.
Methods
All patients were randomized into either the OTDMS group using OneTouch Ultra or the control groups not using it. Both groups had conventional DM education and only the OTDMS group used data from OTDMS as explanation materials during consultation hours. At enrollment and after 6 months, we performed a questionnaire survey consisting of the diabetes knowledge test, items for compliance of treatment, patient's satisfaction, doctor-patient reliability, and glycosylated hemoglobin (HbA1c).
Results
We analyzed 6-month follow-up data from 92 patients (OTDMS 42 vs. control 50). Both groups showed significant improvements in HbA1c, diabetes knowledge, compliance, reliability, and satisfaction after 6 months. However, there were no significant differences between OTDMS and control groups overall. Only "weekly frequency of checking blood glucose level" of compliance and "trying to follow doctor's order" of reliability showed better results in the OTDMS group.
Conclusion
Using the OTDMS system for explanation during consultation hours seems to be more helpful to improve patient's compliance and reliability, especially for checking blood glucose level and trying to follow the doctor's order.
INTRODUCTION
To assess the effectiveness of the management plan in glycemic control, patient self-monitoring of blood glucose (SMBG) and glycosylated hemoglobin (HbA1c) have been applied. SMBG reflects the adequacy of treatment, promotes healthy behavior, and improves clinical course. The results of SMBG are valuable and useful for treatment only when it is collected well and analyzed exactly [12]. Polonsky et al. [2] reported that appropriate and structured SMBG significantly improved glycemic control and facilitated more timely/aggressive treatment changes in noninsulin-treated type 2 diabetes mellitus (T2DM), without decreasing general well-being. SMBG has become a component of effective therapy.
However, patient-generated SMBG diary records are known to have more recording error compared with meter memory. A systematic review showed three types of recording error in patient diaries, which incorrectly recorded a value that had been measured (lack of concordance), failed to record a value that had been measured (under-reporting), and added a value to the diary that had not been measured (over-reporting) [3].
For appropriate SMBG, physicians can correctly identify glycemic abnormalities in SMBG data obtained through structured, episodic SMBG [4]. Collecting blood glucose level and showing it as a time-based graph would help doctors to see blood glucose control intuitionally. Data collection tools such as structured SMBG could help physicians.
OneTouch Diabetes Management Software (OTDMS) is designed to track and monitor the blood glucose level. OneTouch Ultra, via the meter's data port, which connects to a glucometer and computer, makes it possible to download data from a point-of-care testing device and transform the numbers of the blood glucose level into a graph, a chart, or statistics.
It shows all data of blood glucose level with marks of "low," "under control," and "high." It also shows daily variation of blood glucose level with line graph and proportion of "low," "under control," and "high" blood glucose level with a pie chart, as well as the distribution of blood glucose level and the proportion of "low," "under control," and "high" blood glucose level according to time variation.
The purpose of this study was to evaluate whether the use of OTDMS would improve patients' (1) knowledge of diabetes mellitus (DM), (2) compliance, (3) satisfaction with doctor and medical treatment, (4) doctor-patient reliability, and (5) glucose control.
METHODS
Patients
This study was conducted in a single center for diabetes education in Korea from August 2009 to October 2010. Patients who fulfilled the following criteria were included in the study: (1) the diagnosis of T2DM according to World Health Organization classification, (2) current treatment with oral hypoglycemic agent(s) for at least 3 months, and (3) willingness and ability to perform SMBG using OneTouch Ultra. Excluded were patients with a history of drug or alcohol abuse, impaired renal function with serum creatinine ≥1.7 mg/dL, cardiac disease (defined as decompensated heart failure [New York Heart Association classification III and IV], unstable angina pectoris, myocardial infarction within the last 12 months, or severe uncontrolled hypertension [systolic blood pressure when seated >180 mm Hg and/or diastolic blood pressure >110 mm Hg]), proliferative retinopathy and/or advanced neuropathy as judged by the investigator, experience and education using the OTDMS system twice or more, as well as those who were treated with any other drug known to affect blood glucose (i.e., monoamine oxidase inhibitors, β-adrenergic agents, anabolic steroids, and systemic glucocorticoids), were pregnant or breast-feeding, and had the intention to become pregnant. The study was approved by Institutional Review Board of Inje University Sanggye Paik Hospital. All patients provided written informed consent before participating in this study.
Study design
We considered the expansion of diabetes knowledge as the primary outcome. We also compared the changes in compliance for treatment, patient's satisfaction, doctor-patient reliability, HbA1c, and frequency of hypoglycemia as secondary outcomes.
A total of 121 patients with T2DM were randomly assigned into two groups: 63 patients were assigned into the OTDMS group and 58 patients were assigned into the control group. We applied repeated measure analysis of variance (ANOVA) for comparison of changes between the OTDMS and control group. We assumed effect size as 0.2, α error as 0.05, power as 0.8, and dropout as 0.2. We used G power to calculate sample size, and the necessary participants were 45 per each group.
We provided all patients conventional education and a home blood glucose meter that automatically transmits blood glucose data to the hospital. For patients in the OTDMS group, nurses provided an OTDMS's report sheet, which showed blood glucose level not only with numbers but also with bar and graph charts (Fig. 1). Doctors explained and educated using OTDMS's report during consultation hours only for patients in the OTDMS group. Patients in the control group also received conventional medical treatment and education without any supporting materials.
After enrollment, all patients visited the outpatient clinic at 1, 2, 3, and 6 months to evaluate vital signs, adverse events, and compliance. Doctors explained the OTDMS results every visit to patients in the OTDMS group. We tested HbA1c assays at enrollment, after 3 months, and after 6 months. We tested diabetes knowledge, compliance for treatment, doctor-patient reliability, and patient's satisfaction using a questionnaire at enrollment and after 6 months.
The diabetes knowledge test consists of 20 items and six additional items only for insulin users (Tables 1 and 2) [5]. The questionnaire for compliance for treatment and doctor-patient reliability includes three items each (Tables 3 and 4). The 10 cm of visual analog scale was used to determine patients' satisfaction with the doctor and medical treatment. Satisfaction score ranged from none to the most extreme satisfaction, without discrete jumps, such as categorizes of none, little, moderate, some, and very much.
Statistics
We expressed categorical variables with numbers and percentages and presented continuous variables with mean±standard deviation. We performed independent t-test and chi-square test to compare age, duration of diabetes, blood glucose profiles, body mass index (BMI), knowledge of diabetes, compliance, and satisfaction between the OTDMS and control groups. We repeated ANOVA to compare difference of changes in knowledge, compliance, and reliability profiles between the OTDMS and control groups. We considered 0.05 as the two-sided statistical significance level. We performed statistical analysis using SPSS version 18.0 (SPSS Inc., Chicago, IL, USA).
For subgroup analysis, we split patients into four groups as follows: (A) patients in the OTDMS group with initial HbA1c <7.5%; (B) patients in OTDMS with initial HbA1c ≥7.5%; (C) patients in the control group with initial HbA1c <7.5%; and (D) patients in the control with initial HbA1c ≥7.5%. We used repeated ANOVA to compare the difference of changes in knowledge, compliance, reliability, satisfaction, and the level of HbA1c. In case of HbA1c, we also checked the groups for significant difference by testing pre- and post-comparison.
RESULTS
Baseline characteristics
In this study, we included 121 patients. Excluded were patients (total 29) who were under 20 years of age (n=3), and who had incomplete data in compliance (n=9), HbA1c (n=13), and BMI (n=4). In total, 92 patients completed this study 42 in OTDMS group and 50 in control group.
We compared baseline characteristics of all patients (Table 5). There was no significant difference in age, sex, duration of diabetes, the level of HbA1c, BMI, and the type of treatment between the OTDMS and control groups. There was no significant difference in knowledge, compliance, reliability, and satisfaction. We also compared the pattern of medical prescription and the change of medical prescription during intervention. There was no significant difference between the OTDMS and control groups.
Comparison between the OTDMS and control groups
Both groups showed significant improvements in diabetes knowledge, compliance, reliability and satisfaction, and HbA1c during the study period (Tables 6 and 7). However, there were no significant differences between the OTDMS and control groups for the overall score. Only "compliance for the weekly frequency of checking blood glucose level" and "trying to follow doctor's order" showed significant difference. Patients in the OTDMS group showed greater increase in the frequency of checking blood glucose level from 1.33±2.58 to 4.02±2.91/week, whereas in the control group, the frequency changed from 1.80±4.11 to 3.34±2.66/week (P<0.001). "Trying to follow doctor's order" showed significant difference by intervention groups. Patients in the OTDMS groups showed greater increase from 3.52±0.59 to 3.74±0.50, whereas patients in the control group showed a slight increase from 3.60±0.61 to 3.66±0.52 (P=0.033).
Comparison according to subgroups
We performed repeated ANOVA for the comparison of subgroups by intervention and initial HbA1c level. There was no significant difference of change in diabetes knowledge, compliance, reliability, and satisfaction. There was significant difference in the change of HbA1c as compared with the baseline (P=0.003) among the four subgroups. In detail, subgroups A and C showed slightly increased HbA1c levels, but these changes were not significant (A, from 6.90±0.53 to 7.24±0.86; B, from 9.51±1.44 to 8.23±1.49). Subgroups B and D showed decreased HbA1c levels, and these changes were significant (C, from 6.87±0.47 to 7.03±0.98; D, from 9.44±1.49 to 8.33±1.71). Therefore, we consider that the OTDMS system benefitted only patients with abnormally high glucose level as HbA1c ≥7.5%.
DISCUSSION
This study evaluated whether the use of OTDMS would improve patients' (1) knowledge of DM, (2) compliance, (3) satisfaction with the doctor and medical treatment, (4) doctor-patient reliability, and (5) glucose control. Both groups showed significant improvement in glucose control based on HbA1c at the end of the study. Patients also showed significant increase in diabetes knowledge, compliance, reliability, and satisfaction. However, there was no significant difference between the OTDMS group and the control group for overall score. Only "compliance with the weekly frequency of checking blood glucose level" and "trying to follow doctor's order" showed significant difference.
The reasons for improvements in all patients regardless of intervention are not clear. We enrolled patients who agreed only. They could have had higher intention to control glucose compared with patients who did not participate. All participating patients received the usual diabetes education and a home blood glucose meter. These overlapping contents between OTDMS and control could weaken the difference. We consider that participation in the study itself would promote patients' knowledge, compliance, reliability, etc. Patients could learn or be stimulated through answering questionnaires. All participating patients also could gain satisfaction through experiencing processes such as the introduction, questionnaire, and feedback.
We conclude that there were no between-group differences for the following reasons: all patients improved; patients who chose to enroll in the study could have already had a higher intention to control blood glucose level, and all patients had the usual diabetes education and received a home blood glucose meter. Fortunately, these factors did not bias the results. Further, we did not hand over the means for patients to control blood glucose level independently. In this study, all patients received the usual medical treatment, and the doctors regulated medicine based on the laboratory results of blood glucose. In addition, the OTDMS system might not be as effective for overall management of blood glucose level in T2DM. In a 6-month randomized controlled trial, the effectiveness of a color-coded HbA1c-graphical record did not improve the HbA1c level among T2DM patients [6]. In other words, it did not improve metabolic control. Moreover, the intervention in this study could be insufficient to promote changes in score. Using a graph, the doctor elaborated on the blood glucose level. However, the consultation time was short, approximately 3 to 5 minutes per visit. This is the usual consultation time in an outpatient clinic in Korea. Consultation time was too short to give appropriate feedback to patients. Meanwhile, some interventions to feedback using computers or mobile devices have reported successes in Korea [789]. Appropriate feedback with sufficient time seems necessary for metabolic improvement. The doctor used only the OTDMS's report sheet and did not use other educational materials. The patients wanted to take steps to control their glucose levels so just showing the results may be insufficient.
Even if the OTDMS and control groups did not show significant difference of change in the overall score, we thought that the OTDMS showed some potential possibility to improve self-help in blood glucose control in T2DM. Patients in the OTDMS group showed better improvements in "compliance with the weekly frequency of checking blood glucose level" and "trying to follow doctor's order." First, there could have been better communication or more feedback in the OTDMS group. There is a possibility that the doctors spent more consultation time explaining the OTDMS results with the OTDMS group than they did with the control group. Although we did not measure the time, the difference is possible. The doctors explained the handwritten SMBG logs only when patients showed them to doctors in the control groups. These factors could have affected the results of "trying to follow doctor's order." Second, the OTDMS system could motivate patients to practice more self-management. Patients could understand more easily their own status of blood glucose control by using color marks, graphs, and charts. These could have prompted patients to check and follow the doctor's order.
Some studies about the clinical evaluation of computer-assisted SMBG system showed different results from ours [1011]. One study found that both the experimental group and the control group had a significant drop in HbA1c during the study period; however, there were no between-group differences, which is similar to our study [10]. However, another study showed that the study group had better improvement of metabolic control compared with the control group [11]. Both studies showed that using the program had a positive effect on self-reported understanding of type 1 DM treatment, perceived importance of testing, the quality of interaction with the physician, patients' diabetes-related behaviors, patient satisfaction, and physician satisfaction [1011]. These different results might be due to the difference of the study population [1011]. There were some limitations in the design of our study. First, the sample size was small and follow-up duration was short. Second, the doctors knew which group the patients belonged to, which could have produced bias.
In conclusion, diabetes education was helpful to patients in both the OTDMS group and the control group. It was helpful to improve knowledge, compliance, reliability, and satisfaction. However, patients who used the OTDMS system did not show more improvements for overall score in comparison with the control group who received only conventional medical treatment and diabetes education. Patients received consultation with the OTDMS's report sheet and showed significantly better change in "weekly frequency of checking blood glucose level" and "trying to follow doctor's order." Using the OTDMS system could be more helpful to improve self-help, especially for checking blood glucose level and trying to follow the doctor's order.
ACKNOWLEDGMENTS
This work was supported by the 2011 Inje University research grant.
Notes
CONFLICTS OF INTEREST: No potential conflict of interest relevant to this article was reported.