Effect of a traditional Chinese medicine theory-based mobile app on improving symptoms in patients with type 2 diabetes mellitus:A randomized controlled trial

Huiwen XU ,Yuan YUAN ,Li YANG ,En TAKASHI ,Akio KITAYAMA

1Department of Medical Nursing,School of Nursing,Yangzhou University,Yangzhou,Jiangsu,China;2Division of Basic and Clinical Medicine,Nagano College of Nursing,Komagane,Nagano,Japan;3Department of Endocrinology,Jiangsu Province Hospital of Chinese Medicine,Nanjing,Jiangsu,China;4Division of Health Science,Nagano College of Nursing,Komagane,Nagano,Japan

ABSTRACT Objective:The aim of this study was to evaluate the effect of the Traditional Chinese Medicine (TCM) theory-based mobile app on improving symptoms in patients with type 2 diabetes mellitus (T2DM) in China.Materials and Methods:A randomized controlled trial was conducted.Ninety-seven patients with T2DM were enrolled and they were randomized into the control group and the experimental group.The control group was given usual diabetes education and follow-up with telephone call,while the experimental group was followed up by using the TCM theory-based mobile app.After 6-month intervention,the diabetic symptom scores,the blood glucose levels,and self-management ability of the two groups were compared.Results:Compared with intervention before,the levels of fasting blood glucose (FBG),2-h postprandial blood glucose (2hPG),and glycated hemoglobin (HbA1c) decreased in the control group (9.28 ± 3.05 vs.8.26 ± 2.73 mmol/L,12.65 ± 4.18 vs.10.65 ± 3.79 mmol/L,and 8.78% ±1.76% vs.7.96% ±1.47%,respectively,all P ＜ 0.05) and also decreased in the experimental group (8.36 ± 2.64 vs.7.35 ± 2.45 mmol/L,11.50 ± 4.29 vs.9.85 ± 2.71 mmol/L,and 8.64% ±2.04% vs.7.29% ±1.56%,respectively,all P ＜ 0.05) after 6-month intervention,while the summary of diabetes self-care activities (SDSCAs) scale scores after 6-month intervention increased significantly in the control group (35.20 ± 14.68 vs.44.78 ± 10.21,P ＜ 0.05) and the experimental group (32.16 ± 13.21 vs.50.37 ± 10.06,P ＜ 0.05).After 6-month intervention,the diabetic symptom scores (18.16 ± 2.74 vs.22.18 ± 4.77) and HbA1c (7.29 ± 1.56% vs.7.96% ±1.47%) were lower,and SDSCA scale scores (50.37 ± 10.06 vs.44.78 ± 10.21) were higher in the experimental group than the control group (all P ＜ 0.05).Conclusion:The mobile app based on TCM theory can effectively improve diabetes-related symptoms in patients with T2DM and help control their blood glucose as well as enhance their self-management ability.

Keywords:App,chronic disease management,diabetes mellitus,traditional Chinese medicine

INTRODUCTION

Diabetes mellitus (DM) is a group of metabolic disorders characterized by high blood glucose levels.It is caused by genetic and environment factors and may result in various severe complications.Over the decades,DM has become a serious health problem worldwide because of its high prevalence and related disability as well as mortality.[1]The International Diabetes Federation,Diabetes Atlas,showed that there were 451 million (age 18-99 years) individuals with DM all over the world in 2017.The figure is expected to rise to 693 million by 2045.China has the world’s largest population with diabetes owing to lifestyle changes and the aging of the population.[2]In 2017,the overall prevalence of diabetes in mainland China was 11.2% (using the World Health Organization criteria).[3]It has become an urgent health problem for the whole country.However,the awareness rate,treatment rate,and compliance rate of DM in China are generally low.It is reported that among the subjects with diabetes,40.3% were aware of their condition;62.9% were receiving treatment,and only 16.9% had controlled diabetes.[4]Poor self-management,lacking of individualized education,and clinical inertia may lead to serious complications related to diabetes,resulting in a high expenditure and decreased quality of life.It puts great burden on health system to manage the patients.

In recent years,the advance of mobile technology such as mobile health application (app) has provided a good opportunity for the long-term management of DM with a platform of technical support and health services.[5]There have been a growing number of smartphone apps developed to manage DM worldwide.As a new form of DM management,smartphone apps are feasible,cheap,and cost-effective.Compared with traditional computer-and web-based telemedicine technologies,[6,7]mobile apps may have their unique advantages in DM management.[8-10]It was previously reported in a 3-month randomized controlled trial (RCT) that DM patients using theWelltangapp have achieved statistically significant improvements in HbA1c,with an average decrease of 1.95%,when compared to the control group with just a 0.79% reduction in HbA1c.[11]

Traditional app-based interventions are more based on western medicine.A systematic review indicates that the majority of diabetes management apps focused on the areas of oral medication management,insulin injection,calories intake,and consumption,[12]all of which are based on western medicine.Unfortunately,there are fewer Traditional Chinese Medicine (TCM)-based app intervention methods.Actually,TCM has become popular worldwide as a form of alternative medicine to improve diabetic symptoms.[13]Combining TCM with mobile app,people can manage their disease more effectively in that the convenient,timely,efficient mega data support of Internet technology can provide sound technical support for TCM remote management of diseases.[14]In 2017,Kanawongetal.[15]developed a mobile app based on TCM callediTongueto help medical practitioners to improve reliability and consistency of tongue diagnosis.In that study,when a user uploads his or her tongue image,the system will analyze the message and then recommend a list of food according to the given message.Similarly,Caoetal.[16]also found that the mobile app based on the guidance of TCM plays an essential role in establishing a stable nurse-patient relationship and improving patients’ compliance.

In TCM,a disease clinically manifested as excessive hunger,polydipsia,and frequent urination,which are similar to those of DM,is named“Xiaoke(consumptive thirst).”[17]TCM holds that consumptive thirst (DM) is mainly caused by yin deficiency,excessive heat,and qi deficiency,so the basic treatment is to nourishing Yin,clear away heat,and invigorating Qi and promoting blood circulation.According to patients’ symptoms,consumptive thirst is divided into the“upper,”“middle,”and“lower”types.Specifically,upper consumptive thirst is manifested as polydipsia,shortness of breath,and palpitation;middle consumptive thirst is manifested as excessive hunger and dry stool (digestive problems);lower consumptive thirst is manifested as frequent micturition with profuse urine and impaired kidney function.[13]

However,no DM management smartphone apps based on TCM theory were found.Therefore,we developed one and applied it to diabetic patients in China to explore the effectiveness of TCM theory-based mobile app in improving diabetic symptoms.We hypothesized that patients with type 2 DM (T2DM) in the experimental group using the TCM theory-based mobile app would have significant improvements in DM symptoms as compared to the control group without using it.

MATERIALS AND METHODS

Ethical considerations

Ethical approval was obtained from the Ethics Committee of Jiangsu Provincial Hospital of Chinese Medicine (no.2015NL-082-02) on 28th March 2016.It strictly followed the Declaration of Helsinki.Before the study,the aim and significance of the intervention was informed to the participants and they were told they could terminate the study at any time.Written informed consents were obtained from all the subjects.

Design

This study was a 6-month,single-centered,prospective RCT.

Development of the smartphone app for diabetes management

The smartphone app for diabetes management (register number:2018SR446465) was compatible with both Android and IOS.It was composed of 4 modules:syndrome differentiation,body differentiation and health preservation,thesaurus,and interactive follow-up.“Syndrome differentiation”was to help differentiate syndromes and to establish nursing methods.“Body differentiation and health preservation”was to help judge the type of patients’ constitution and provide appropriate methods to preserve health.For example,it provided dietotherapy prescription based on personal body constitution referring to TCM theory in this module.“Thesaurus”was to deliver a variety of diabetes self-management strategies as well as diabetes-related knowledge based on evidence for the patients to search.“Interactive follow-up”was to provide a platform for the patients to record and upload their daily diet,medication,exercise,and blood glucose readings.A reminder message would be received if the patients forget to complete that in time.The diabetes educators can track the data from the app and provide specific guidance and suggestions for the clients.

Participants

Participants were recruited from the Department of Endocrinology of Jiangsu Province Hospital of Chinese Medicine between July,2015 and December,2016.Inpatients (aged 18-65 years) diagnosed with T2DM were enrolled according to the 2010 American Diabetes Association criteria,[18]with the duration of disease ＞3 months and HbA1c＞6.5%.To be eligible,patients should possess and be able to use a smartphone,being willing to participate in the study and sign a written informed consent.The exclusion criteria were as follows:(1) pregnant;(2) severe complications or systemic diseases;(3) severe hearing or visual impairment;(4) cancer;(5) be unable to take care of themselves;and (6) participate in other studies.A total of 97 patients were recruited in the study according to the inclusion and exclusion criteria.Random serial numbers were generated by computer,with the odd number as the experimental group (47 cases) and the even number as the control group (50 cases).During the study,3 cases in the experimental group and 5 cases in the control group were lost,resulting in a total of 89 patients included in the final analysis [Figure 1].

Intervention Baseline assessment

The questionnaires were distributed to the participants once they were enrolled in the study.The investigators,who were trained by the researcher,would explain the aim of the study for the participants and guide them to complete the questionnaires.After that,the investigators were also responsible for checking the questionnaires.

The control group

During the period of hospitalization,diabetes specialist nurses in the endocrinology department made a health management plan for the patients.In addition,a face-to-face individualized health education was conducted for each patient for 4 times,30 min each time within 4 days when admitted to the hospital.The health education contents include self-management knowledge and TCM nursing related to diabetes.Diabetes self-management knowledge refers to the outline ofChineseGuidelineofDiabetesCareandEducation.[19]Education related to TCM nursing of diabetes was aligned with the TCM nursing program of consumptive thirst ofTCMNursingProgrammefor13DominantDiseases.After discharge,the patients were followed up through telephone call by nurses every month.The patients’ blood glucose and self-management problems were recorded,and health education was provided to them regarding their blood glucose.

The experimental group

The patients in the experimental group received the same health education as the control group during their hospitalization.Before discharge,the patients were guided to download an app to help them manage diabetes.To avoid possible contamination,patients could install the app only if they received a code from the nurse.That means,they could not use it without the permission of the nurses.

The procedure was as follows:the first step was establishing a diabetes education group.The diabetes education group consists of a chief physician (served as educational consultant),a head nurse (responsible for supervision),and 5 nurses (responsible for carrying out the health education and follow-up management) in the endocrinology department.All the nurses enrolled are required to have bachelor degree or above,nurse title or above,and more than 5 years of nursing work experience.The second step was training the participants to use the app.All the medical staff involved in the research should download and install this software.They were all trained by the researcher to be familiar with the functions and usage of the software.Patients in the experimental group were required to install the software and register in the app before they were discharged from the hospital.In addition,the caregivers should teach the participants to use the app correctly and ensure that they could use it by themselves.The third step was the application of the app.Once the patients began to use the app,they were required to complete questionnaires to differentiate their syndrome and body constitution in the“syndrome differentiation”and“body differentiation and health preservation”modules,respectively.Then,specific,individualized self-management programs based on TCM theory would be developed according to the results.In addition,they were reminded to submit their management status including food intake,exercise,blood glucose readings,mental status as well as medication taking to the“interactive follow-up”module every day.All the data were available for the nurses and the caregivers who would provide some suggestions for the patients if they reported unsatisfactory health data.The patients may also consult the nurses online and search some information related to DM with the app.

All the participants were followed up for 6 months.Data were collected at the baseline and 6 months after intervention.

Outcome measures

The primary outcome was diabetic symptom scores.It was assessed by the diabetes symptom grading and quantitative scale according to theGuidelinesfortheClinicalResearchofChineseMedicineNewDrugs,[20]each item was scored 2 points (mild),4 points (moderate),and 6 points (severe).This is a symptom quantification scale targeted at diabetes patients,widely used in clinical practice.Secondary outcome was blood glucose level including fasting blood glucose,2-h postprandial blood glucose (2 hPG),and glycated hemoglobin (HbA1c) at baseline and 6 months after intervention.Serum HbA1clevel reflects a patient’s blood glucose concentration during the previous 2-3 months,[21]so it was taken into consideration as an essential indicator.Diabetes self-management ability was assessed by the summary of diabetes self-care activities (SDSCAs).The scale was originally developed by Toobertet al.[22]in 2000 and was translated into Chinese and validated by Sunetal.,[23]with an internal consistency of 0.62-0.92.[23]It is a self-reported scale to assess the frequency of performing diabetic self-care tasks within 1 week,including six subscales,namely diet control,exercise,medication adherence,blood glucose monitoring,foot care,and smoking.The participants were required to circle how many days in the past 7 days he/she complete a specific behavior.Higher scores indicate higher levels of self-management activities.The Chinese version of SDSCA is freely available.

Statistical analysis

Descriptive data were used to summarize patient characteristic and baseline blood glucose levels,including means and standard deviation for continuous variables and proportions for categorical variables.Independent samplet-test,Chi-square,and Mann-Whitney U test were used to compare the difference between the two groups,and paired samplet-test was used for comparing the difference before and after intervention.All analysis was performed by SPSS 20.0 statistical software (IBM Corporation,New York,NY,USA).Two-tailedP＜ 0.05 was considered statistically significant.

RESULTS

A total of 89 patients completed 6-month intervention.Fifty-six persons were male and 33 were female.The mean age of the participants in the control group and experimental group was 53.78 ± 10.20 and 50.82 ± 11.30 years,respectively.The general characteristics and the health-related history of the patients are shown in Table 1.

There was a significant difference between the experimental group and the control group in diabetic symptom scores after intervention (P＜ 0.05) [Table 2].

Table 3 illustrated the difference of blood glucose levels before and after intervention in the two groups.The results showed that blood glucose decreased after intervention in both groups (P＜ 0.05).The pairedt-test result presented the HbA1cin the experimental group decreased significantly more than the control group after intervention (P＜ 0.05).

Table 4 showed the difference of SDSCA scores before and after intervention in two groups.The results indicated that SDSCA scores increased significantly in both groups,and the experimental group got higher scores than the control group in diet control,exercise,and blood glucose monitoring after intervention (P＜ 0.05).

Table 2:Comparison of diabetic symptom scores between two groups before and after intervention

Table 3:Comparison of blood glucose levels in two groups before and after intervention

Table 4:Comparison of summary of diabetes self-care activities scores in two groups before and after intervention

DISCUSSION

In this study,we evaluated the effectiveness of a mobile app based on TCM theory.To our knowledge,it was the first app designed based on TCM theory to manage T2DM.Over the years,telephone follow-up has been popular and used as a main method to conduct continuing care,but its disadvantages have appeared in recent years owing to its unidirectionality.By contrast,the mobile app is bidirectional and real time.The patients can contact the nurses online whenever they need.The mobile app provides a platform for communication between nurses and patients through high-efficiency interactive feedback.[24]In the“interactive follow-up”module,the patients may receive advice related to their demand so that they can change their inappropriate lifestyle or wrong behavior,which is helpful for controlling blood glucose in the long-term and prevent diabetes-related comorbidities.In addition,the mobile app has formulated a precise care plan for all registered users according to their body constitution and symptoms and has provided convenient holistic care information based on TCM theory from aspects of TCM diet therapy,acupoint massage,Qigong,moxa-moxibustion,etc.

Clinically,most diabetic patients have diabetes-related symptoms such as fatigue,insomnia,and constipation,which seriously influence the quality of life of the patients.Its impact on the quality of life can be reflected by diabetic symptoms scores.The study was found that the average diabetic symptom scores of the patients were higher than 20 points before the intervention,which indicated that the patients underwent severe physical symptoms.As the duration of diabetes increases,diabetes-related comorbidities develop gradually,such as diabetic peripheral neuropathy (DPN) and peripheral vascular diseases,and patients may have numbness in the lower limbs,pain,and constipation.Although some drugs can relieve their symptoms,most of them are temporary and drug resistance is common.A number of studies have shown that TCM has certain advantages in interfering with the diabetes-related symptoms.Liuetal.[25]used foot bath with Chinese medicine to treat patients with DPN and found that their nerve conduction velocity was improved.For the diabetic patients with insomnia,Yang[26]treated them with TCM constitution adjustment nursing according to their physical characteristics and found that the patients’ sleep quality as well as quality of life were improved after 6-month intervention,which was consistent with our study.In the present study,after intervention,the patients’ symptoms including insomnia,constipation,and thirsty were all improved.The participants who used the mobile app reported that the personalized self-management strategy was the best part of this app.

TCM demonstrated promising effects in lowering glucose and improving clinical symptoms caused by DM.From perspective of TCM,DM is not limited to a single type of body constitution,which mainly depended on the degree of“dryness”and“dampness”according to different stage of the disease.[27,28]In general,DM patients possess a constitution of“dryness heat due to Yin deficiency”in the lung,stomach,and kidney,which thus result in polydipsia,excessive hunger,and polyuria.[28]As a result,the possible TCM remedies would be to clear away heat,nourish Yin,strengthen Qi flow and promote blood circulation to restore the balance of body.[13]Herbal therapy,food therapy,acupoint massage as well as moxibustion are all proved effective in improving diabetes-related symptoms.For example,ginseng has been shown to alleviate diabetes symptoms by increasing insulin secretion,promoting insulin sensitivity,and regulating specific enzymes involved in glucose metabolism.[29]Certain foods are consumed as herbal preparations and meals due to its antioxidant and insulin-like properties.[30]The Zhongwan (CV12) and Zusanli (ST36) points are common insertion points in diabetes acupoint stimulation and have been experimentally proved to decline glucose levels when treated in rats.[31]Previous study has proved that Zuogui Pill,red raspberry tea,andOrthosiphonstamineuscan alleviate the associated pathophysiology of gestational DM with minimum toxicity to the mother and fetus.[32]Tianhuafen (Radixtrichosanthis) and Huanglian (Rhizomacoptidis) are used to treat excessive heat in the stomach (a common course of diabetes).[33]Another review found that practice of Qigong produced an overall positive outlook on diabetes.[34]

After 6-month intervention,FPG,2 hPG,and HbA1cdecreased in the two groups (P＜ 0.05).The experimental group has greater strength than the control group in the improvement of HbA1c(P＜ 0.05),suggesting that mobile app based on TCM theory can improve the blood glucose in patients with diabetes.Lots of RCTs have also demonstrated the benefits of diabetes mobile apps on improving glycemic control in patients with diabetes.[35-37]These apps help to improve glycemic control through enhancing diabetes knowledge,self-management abilities,adherence to medication-taking,and healthy lifestyle guidance.[38-40]In our study,diabetes educators would be informed of the user’s health condition in real time according to the data uploaded by the users.They may deliver guidance for the patients who have a poor blood glucose control.As a result,the patients gradually adhere to the nurses’ guidance and keep their blood glucosein a stable and standard level.Possibly,it might also be due to the improved awareness of the consequences of failing to monitor blood glucose levels.[41]This is essential because frequent self-monitoring is known to improve glycemic control.[42]

We also evaluated the effect of the mobile app on self-management ability,and the result suggested that the SDSCA scores of the experimental group were higher than those of the control group,especially in diet control,exercise,and blood glucose monitoring,which means that the mobile app based on TCM theory can effectively improve patients self-management ability,increased physical activity,and decreased saturated fat intake and mediated the treatment effect.A recent systematic review and meta-analysis[43]indicates that the mobile apps are promising ways of delivering self-management interventions and achieving clinical effectiveness in patients with DM.In the present study,participants also reported that the app was helpful for completing self-care tasks,including nutrition monitoring and increasing activity,which was in line with the findings of Brzanetal.[12]Moreover,Cafazzoetal.[44]found that the use of a mobile app led to a 49.6% increase in the frequency of blood glucose measurements at the end of a 12-week period.These results further emphasize that mobile apps can effectively engage patients,influence their behavior positively,and potentially improve health outcomes.This is mainly due to the reasons that diabetes app use may be a useful approach to improve diabetes knowledge,self-management skills,and knowledge about complications which may ultimately enhance self-care practice.[45]

Various apps are developed for diabetes management nowadays,but most of them are commercially available and are not evidence based.[46]In addition,they focus mainly on blood glucose readings,[47]but the symptoms related to diabetes are ignored.A study on popular glucose tracking apps on android and apple store identified 20 most popular apps and reported glucose tracking and physical activity as the most common features of the apps.[39]However,the mobile app based on TCM theory provides not only the glucose tracking,physical activity,but also develops an individualized,integrated self-management plan for different patients,and all the recommendations are evidence based.Moreover,the patients’ mental health was also taken into consideration.Hence,the mobile app we developed can play important roles in both symptom improvement and blood glucose control.

Limitations

Although our study has proved the efficacy of the mobile app based on TCM theory in patients with T2DM,we collected data at baseline and 6 month after intervention only.The further research was necessary to evaluate the effectiveness of the app in 12 month,2 year,and longer.In addition,some patients were lost during follow-up for their reluctance to be disturbed frequently.It is recommended that future studies are conducted with a larger sample size so that the effect of the intervention on other dimensions (such as psychology and quality of life) can also be considered.Finally,what should also be kept in mind is that the study was not blinded,so a placebo effect cannot be ruled out.

CONCLUSION

The result of the present study indicates that the application of mobile app based on TCM theory is effective to improve diabetes-related symptoms and decrease blood glucose as well as enhance self-management capabilities for patients with diabetes.TCM shows its advantages in alleviating the symptoms associated with diabetes (e.g.,excessive hunger and thirst,frequent urination,weight loss,fatigue,and blurred vision).It can be an appealing alternative therapy for patients with T2DM.

Declaration of patient consent

The authors certify that they have obtained all appropriate patient consent forms.In the form,the patients have given their consent for clinical information to be reported in the journal.The patients understand that their names and initials will not be published and due efforts will be made to conceal their identity,but anonymity cannot be guaranteed.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.