Efficacy of a smartphone application for helping individuals with type 2 diabetes mellitus manage their blood glucose: a trial protocol

doi:10.21203/rs.3.rs-2320328/v1

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Study protocol

Efficacy of a smartphone application for helping individuals with type 2 diabetes mellitus manage their blood glucose: a trial protocol

https://doi.org/10.21203/rs.3.rs-2320328/v1

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Background: China has the largest number of individuals with type 2 diabetes mellitus (T2DM) in the world, and most lack knowledge about glycemic control and health management. This trial will examine whether a smartphone application can improve blood glucose management among individuals with T2DM.

Methods: This will be a multicenter randomized controlled trial conducted in outpatient endocrinology clinics at two tertiary hospitals in Chengdu, China. The trial will enroll smartphone-literature individuals at least 18 years old who have been diagnosed with T2DM based on glycosylated hemoglobin (HbA_1c)of at least 7.0%. Individuals will be randomly assigned to receive routine care with standard education about T2DM and glycemic control (Control), routine care as well as weekly telephone reminders to self-monitor blood glucose (Reminder), routine care and a smartphone application providing information about glycemic control and health management with T2DM (App), or the combination of routine care, the smartphone application and weekly telephone reminders (App+Reminder). After six months of these interventions, participants will be analyzed for the primary outcome of HbA_1c as well as the secondary outcomes of blood glucose monitoring frequency, body mass index, waist-hip ratio, blood pressure, diabetes-related medical costs, disease progression or improvement, knowledge about diabetes, health beliefs related to diabetes, diabetes self-management behavior, and satisfaction with the smartphone application.

Discussion: This trial will determine whether a smartphone application can improve glycemic management among Chinese with T2DM. The findings may help guide the development of effective applications in China and elsewhere.

Trial registration: The trial was prospectively registered on January 17, 2021 at the Chinese Clinical Trial Registry (ChiCTR) under registration number ChiCTR2100042297.

Type 2 diabetes mellitus

Health education app

Blood glucose management

Blood glucose monitoring

Chinese.

In 2021, approximately 537 million people 20–79 years old had diabetes, according to the International Diabetes Federation [1]. China contains the largest proportion of these individuals, most of whom have type 2 diabetes mellitus (T2DM) [1]. People with T2DM should self-monitor blood glucose levels in order to adjust their lifestyle and diet as needed to ensure good glycemic control. However, many individuals with T2DM do not self-monitor [2].

The ubiquity of smartphones and smartphone-based applications (“apps”) provides an excellent opportunity for educating individuals with T2DM about their condition and promoting self-monitoring of blood glucose. Current estimates suggest that nearly 1,700 smartphone applications related to diabetes exist [3]. Studies so far have suggested that such applications can help people manage the disease [4] as well as reduce body weight and blood glucose level [5–6].

However, a survey of 30 provinces in China in 2019 showed that only about 10% of individuals with T2DM used applications related to diabetes [7]. Use of applications was particularly low in Sichuan Province, which may reflect that its per capita gross domestic product (GDP) is substantially lower than that of the 10 Chinese provinces with highest per capita GDP [7].

A survey of more than 1276 individuals with T2DM identified “Dnurse” (dnurse.com/v2/app) as the most popular diabetes-related smartphone application in China [7]. The present trial will assess whether Dnurse can help individuals with T2DM manage their glucose levels and, more generally, their disease condition. It will also assess user satisfaction with the application.

Research question

The primary objective of this multicenter, randomized controlled trial is to evaluate the effect of the smartphone application Dnurse on glycemic management and disease control in individuals with T2DM. As secondary objectives, the trial will assess whether the application influences compliance with blood glucose monitoring, and it will measure user satisfaction with the application.

Study design

This will be a multicenter randomized controlled trial conducted in outpatient endocrinology clinics at two tertiary hospitals in Chengdu, China, which will be conducted from 2021 to 2023 using the convenience sampling method. Individuals will be randomly allocationed to Control group, Reminder group, App group and App + Reminder group.

Trial registration and ethics compliance

The trial protocol was approved by the Ethics Committee of the First Affiliated Hospital of Chengdu Medical College (2020CYFYIRB-BA-129-F01) and prospectively registered at the Chinese Clinical Trial Registry under registration number ChiCTR2100042297. The study will be carried out in accordance with the Declaration of Helsinki. Written informed consent is obtained from participants prior to enrollment.

Study sites

Since October 2021, the trial has been underway at two tertiary general hospitals (“grade A” in the Chinese hospital classification scheme) in Chengdu, China. At each site, two researchers have been designated to carry out the trial. A SPIRIT schedule of procedures and events is demonstrated in Table 1.

Table 1

Schedule of procedures and assessments.
	STUDY PERIOD
	Enrolement	Baseline	Intervention	Endpoint
TIMEPOINT	-	0 months	3 months	6 months
ENROLEMENT:
Eligibility screen	X
Informed consent	X
Allocation	X
INTERVENTIONS:
Control group		X	X
Reminder group		X	X
App group		X	X
App + Reminder group		X	X
ASSESSMENTS:
chronic complications related to diabete		X		X
acute complications related to diabetes		X		X
diabetes treatments		X		X
DKN,HBQ,2-DSCS		X		X
satisfaction with the smartphone application				X
height, weight, blood pressure, waist circumference, hip circumference and HbA_1c		X	X	X
frequency of blood glucose monitoring			X	X
Chronic complications related to diabete: hypertension, cardiovascular disease, cerebrovascular disease, peripheral vascular disease, kidney disease, peripheral neuropathy, eye disease and diabetic foot; acute complications related to diabetes: hypoglycemia and lactic acidosis or ketoacidosis; diabetes treatments: non-drug therapy, oral hypoglycemic drugs, and insulin therapy; DKN: Diabetes Knowledge Scale; HBQ: Health Belief Questionnaire; 2-DSCS: Type 2 Diabetes Self-management Behavior Scale; User satisfaction with Dnurse application and its paired glucose meter: Custom-made questionnaire to assess user satisfaction with Dnurse application and its paired glucose meter; HbA_1c: glycosylated hemoglobin.

Participants

Recruitment was carried out online, through announcements in outpatient departments, and by telephone from the National Center for Standardized Metabolic Management (Chengdu, China). For the online recruitment announcement, health education nurses at the the First Affiliated Hospital of Chengdu Medical College sent recruitment information to a WeChat group of individuals with T2DM that is managed by the National Center. Recruitment advertisements were posted on the bulletin boards of outpatient departments at the two study sites. Researchers also contacted patients using the telephone numbers on record at the National Center.

Individuals were enrolled only if they satisfied all the following inclusion criteria: (1) diagnosis with T2DM based on the criteria of the World Health Organization glycosylated hemoglobin (HbA_1c) ≥ 7.0%) [8], (2) at least a primary school education, (3) at least 18 years of old, (4) smartphone literacy, (5) residence in Chengdu for at least the previous 12 months, and (6) willingness to participate and provide informed consent. Smartphone literacy was assessed by asking potential participants whether more than three commonly used applications were installed on their smartphones.

People were not enrolled in the study if they met any of the following criteria: (1) previous experience with a diabetes-related application, (2) history of mental illness, cognitive impairment, or communication disorder, based on self-report, (3) pregnancy or plans to become pregnant, (4) treatment for cardiac or other life-threatening condition during the previous six months or (5) current diabetes-related hospitalization.

After enrollment, data were collected from the individual and his or her blood was sampled, as described below.

Randomization and interventions

Before enrollment began, two groups of random numbers were generated using Microsoft Word and placed into serially numbered, opaque envelopes. After baseline assessment was complete (see above), each participant selected an envelope, which indicated his or her allocation to one of the four groups described below. Equal numbers of participants were recruited at each study site and allocated equally into the four groups. All participants received a free blood glucose meter during the trial as well as sufficient blood glucose test strips.

The Control group will undergo routine diabetes management: they will receive a standard portable glucose meter (Dnurse He pro wisdom; Beijing Dnurse Technology Ltd, Beijing, China) and blood glucose monitoring record book. The recommended timing and frequency of blood glucose monitoring will be explained to them according to national guidelines [9]. At the end of the trial, the Control group will be informed about the smartphone application given to the other groups, and they will be invited to use it if they wish.

The Reminder group will receive the same materials as the Control group as well as a weekly telephone reminder to self-monitor blood glucose regularly. These reminders will be given by specially selected nursing undergraduates who have been trained in the rationale, interventions and objectives of the study. Only nursing students who performed well on post-training testing are allowed to participate in the study. During the telephone call, students will ask participants whether they are self-monitoring regularly and, if not, what are the reasons.

The App group will receive a smart blood glucose meter (Dnurse SPUG mobile blood glucose uric acid tester; Beijing Dnurse Technology Ltd) and they will be led by a specially trainer researcher to download the Dnurse App 4.0.16 (dnurse.com/v2/app), designed to work smoothly with the smart blood glucose meter. The researcher will show the study participants how to open a personal account on the application and how to generate personalized diet and exercise programs, glucose control targets, and a blood glucose monitoring plan; how to access the food bank, disease information, and real-time blood glucose analysis and recommendations within the application; and how to set reminders to take medication and engage in other behaviors. This device has received ISO13485 and EU CE certifications.

The App + Reminder group will receive the same materials and training as the App group, together with weekly telephone reminders like the Reminder group.

If members of the Control group and the Reminder group experience acute complications of diabetes, such as excessively high or low blood glucose, trial investigators will advise them to seek medical treatment as per standard procedures. If members of the App group and the App + Reminder group trigger a “critical value” alarm on the application, the customer service staff of the application’s manufacturer will call them by telephone and provide advice or information as per standard procedures.

Allocation concealment and blinding

Participants will not be blinded to their group allocation, but investigators will be blinded during baseline assessment.

Sample size

Using GPower 3.1 (University of Kiel, Kiel, Germany), we determined a minimal sample of 260 individuals for a default medium effect size of 0.26, two-sided A = 0.05, test power (1-β) of 0.9, and the F-test. To compensate for an estimated 20% loss to follow-up, we plan to recruit 65 subjects into each of the four groups.

Outcomes

The primary outcome is level of HbA_1c, which reflects blood glucose levels over the preceding 2–3 months and is a good indicator of blood glucose control [10–11]. All determinations will be made by high-performance liquid chromatography at the same certified external laboratory to ensure consistency.

Secondary outcomes include frequency of blood glucose monitoring, body mass index, waist-to-hip ratio, blood pressure, diabetes-related medical costs, diabetes progression or improvement, knowledge about diabetes, health beliefs related to diabetes, and diabetes self-management behavior. The App and the App + Reminder groups will also be asked about their satisfaction with the smartphone application.

Assessments

The workflow of the study is summarized in Fig. 1. At baseline, demographic data will be collected on age, sex, ethnicity, educational level, marital status, employment status, current residence, and method of paying for medical expenses.

At baseline, data will be collected on the following clinical variables: chronic complications related to diabetes, such as hypertension, cardiovascular disease, cerebrovascular disease, peripheral vascular disease, kidney disease, peripheral neuropathy, eye disease and diabetic foot. Any chronic complications of diabetes that arise during the study will be recorded at 6 months. Similarly, data on acute complications related to diabetes will be collected at baseline, such as hypoglycemia and lactic acidosis or ketoacidosis; and current diabetes treatments, including non-drug therapy, oral hypoglycemic drugs, and insulin therapy. Any acute complications of diabetes that arise during the study will be recorded at 6 months.

At baseline and again at 6 months, all participants will be asked to fill out three questionnaires (Table 2). In addition, the App and the App + Reminder groups will fill out a fourth questionnaire at 6 months, which assesses their satisfaction with the smartphone application and glucose meter (Table 3). All questionnaires will be filled out online using Questionnaire Star (www.wjx.cn).

Table 2

Description of questionnaires in the trial.
Questionnaire	Description	Score range	Assessment timepoint(s)
Diabetes Knowledge Scale [17](DKN)	Chinese version of the Diabetes Knowledge Questionnaire [18]. The Cronbach α coefficient of each question of the scale was above 0.70, and the content validity was above 0.60 [19]. The scale consists of 23 single-choice questions, among which questions 1–14 are general while questions 15–23 are specific to individuals taking treatments involving insulin, diet, exercise, drug therapy, blood glucose testing, foot care, or prevention of hypoglycemia.	Each item is scored from 0 to 1, and the total score ranges from 0 to 23. Higher scores indicate greater knowledge of diabetes.	Baseline 6 months
Health Belief Questionnaire [20](HBQ)	Chinese version of the questionnaire designed by Becker [21]. The reliability of the scale was 0.82, and Cronbach α coefficient was 0.79 [20]. Health beliefs across five dimensions are explored: the 20 items ask about beliefs concerning the benefits of diabetes treatment (7 items), the necessity of diabetes treatment (5 items), harms associated with diabetes treatment (2 items), motivation for staying healthy (3 items), and harms related to diabetes (3 items).	Responses are scored on a 5-point Likert scale. Scores on each item range from 1 (strongly disagree) to 5 (strongly agree). Several items apply inverted scoring. Total score ranges from 20 to 100.	Baseline 6 months
Type 2 Diabetes Self-management Behavior Scale [22](2-DSCS)	Chinese version of the questionnaire by Hurley and Shea [23]. The Cronbach α coefficient was 0.87, the construct validity was 0.68 [22]. Six dimensions are assessed: dietary control (6 items), regular exercise (4 items), compliance with prescribed medication (3 items), blood glucose monitoring (4 items), foot care (5 items), as well as prevention and management of hypo- and hyperglycemia (4 items).	Responses are scored on a 5-point Likert scale, with 1 indicating complete failure and 5, complete success. Total score ranges from 26 to 130.	Baseline 6 months
User satisfaction with Dnurse application and its paired glucose meter	Custom-made questionnaire to evaluate the participants’ satisfaction with the smartphone application (8 items) and paired glucose meter (3 items).	Responses are scored on a 5-point Likert scale. Total score ranges from 11 to 55.	6 months

Table 3

Custom-made questionnaire to assess user satisfaction with Dnurse application and its paired glucose meter.
Item	Very satisfied	Satisfied	Neither satisfied nor dissatisfied	Slightly dissatisfied	Very dissatisfied
1. Your satisfaction with the application interface
2. Your satisfaction with the application’s ease of use
3. Your satisfaction with how the application records blood glucose
4. Your satisfaction with the health information provided by the application
5. Your satisfaction with using the application to manage diabetes
6. Your satisfaction with the application’s safety
7. Your satisfaction with the application’s performance (accuracy of results, speed of responses)
8. Your overall satisfaction with the application
9. Your satisfaction with the ease of operation of the glucose meter
10. Your satisfaction with the stability of the connection between the glucose meter and application
11. Your overall satisfaction with the glucose meter
Instructions: Please choose the one response with which you agree most.

At baseline and again at 3 and 6 months, data will be collected on height, weight, blood pressure, waist circumference, hip circumference and HbA_1c. At 3 and 6 months, all participants will be asked about their frequency of blood glucose monitoring.

Statistical analysis

Data will be analyzed using SPSS 23.0 (IBM, Chicago, IL, USA) using the intention-to-treat principle. Data will be expressed as mean ± standard deviation, or as n (%) in the case of categorical data,and differences between the four groups will be assessed for significance using the chi-squared test in the case, analysis of variance in the case, or non-parametric rank-sum test in the case of skewed continuous data. Differences between different time points within each group will be assessed for significance using generalized estimation equation. These models will include intervention variables, time as a categorical variable represented by dummy variables, the interaction between intervention and time, and baseline values. Differences associated with P < 0.05 will be considered significant.

This trial aims to assess whether the smartphone application Dnurse can improve glycemic management and disease control in T2DM patients. Smartphone-based management and follow-up of diabetes is much less labor-intensive than direct follow-up by clinicians, and it can give individuals a sense of power and ownership of their condition, which may improve self-monitoring and treatment compliance [12–13].

Despite the potential for smartphone applications to help people adopt healthier dietary and lifestyle behaviors [14], several studies suggest that they are not always effective. For example, a systematic review [15] found that only one of 11 studies assessing whether smartphone applications can improve T2DM self-management found a significant difference in HbA_1c related to application use, none of seven studies assessing blood pressure found a significant difference, and only one of two studies assessing self-care found a significant difference. The investigators in those studies concluded that Apps had the potential to enhance diabetes management and glycemic control, but that further research was needed. The present trial will explore this potential using a rigorous, randomized design that will benchmark the application against routine care as well as telephone reminders. In addition, the trial will not exclude individuals with T2DM who are elderly or have diabetic eye diseases, which may make the findings of our study generalizable to a larger proportion of the global population with T2DM. Finally, our trial will substantially extend the literature on diabetes-related smartphone applications by examining a Chinese population, in contrast to the Western populations in most previous studies. China contains the largest number of smartphonne users worldwide (nearly 1 billion), and use of smarphone applications can be substantially higher there than in the West [16] .

In a survey in China, the Dnurse application was the most popular among T2DM patients and second most popular among individuals with type 1 diabetes [7]. It will be matched in the trial to a blood glucose meter from the same manufacturer, such that blood glucose data will be transmitted automatically to the application. This relieves the individual from having to input data him- or herself, which may improve compliance with blood glucose monitoring [7].

Limitations of the trial design

Although this trial will apply a rigorous randomization protocol to individuals recruited from two large medical centers in China, its design has some shortcomings that should be considered when interpreting the results. Whether the results obtained in this trial can be generalized to other T2DM populations in China will need to be examined in additional studies.We cannot exclude that members of the Control group may use diabetes-related applications during the study, but at least they will be unable to use the Dnurse application, which is the focus of the trial. The follow-up period of 6 months will allow the effects of the application to be assessed in the mid-term while minimizing loss of participants, but longer follow-up will be needed to assess the application’s long-term effects, such as on the occurrence of diabetic complications.

T2DM type 2 diabetes mellitus

HbA_1cglycosylated hemoglobin

apps applications

GDP gross domestic product

DKN Diabetes Knowledge Scale

HBQ Health Belief Questionnaire

2-DSCS Type 2 Diabetes Self-management Behavior Scale

Acknowledgements

We would like to thank the Beijing Dnurse Technology Ltd for funding the present research. We would like to appreciate all the medical officers, staff nurses from 2 hospital for their contributions in recruitment.

Authors’ contributors

Hongxia Tang and Hua Qin drafted the manuscript. Zhenzhen Xiong and Kun Zhang revised the manuscript. Zhenzhen Xiong received the funding for this project and, together with Hongxia Tang, Hua Qin, Mingjiao Zhang, Jihong Zhang, Huiwen Tan, Mengjie Chen, Fenghui Hu, Xiaoxia Wang, Kun Zhang contributed to the design of the trial. Laixi Kong, Maoting Guo and Qin Wang will lead the process of randomization and statistical analysis. All authors contributed to writing the manuscript and no professional writers had been involved. The authors read and approved the final manuscript.

Fouding

This work was supported by Beijing Dnurse Technology Ltd (Beijing, China). The funding body did not play any role in the study design and writing the manuscript.

Availability of data and materials

This study protocol does not report any data, so data sharing is not applicable.

Ethics approval and consent to participate

Ethical approval has been obtained from the Ethics Committee of the First Affiliated Hospital of Chengdu Medical College (2020CYFYIRB-BA-129-F01). The study will be carried out in accordance with the Declaration of Helsinki. The written consent will be informed and obtained from all participants.

Consent for publication

Not applicable.

Conflicts of interest

Hongxia Tang、Hua Qin、Mingjiao Zhang、Jihong Zhang、Huiwen Tan、Mengjie Chen、 Laixi Kong、Maoting Guo、Fenghui Hu、Qin Wang、Xiaoxia Wang and Kun Zhang state that they have no competing interests. Zhenzhen Xiong received funding and equipment support from Beijing Dnurse Technology Ltd to the study.

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Competing interest reported. Hongxia Tang、Hua Qin、Mingjiao Zhang、Jihong Zhang、Huiwen Tan、Mengjie Chen、 Laixi Kong、Maoting Guo、Fenghui Hu、Qin Wang、Xiaoxia Wang and Kun Zhang state that they have no competing interests. Zhenzhen Xiong received funding and equipment support from Beijing Dnurse Technology Ltd to the study.

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Efficacy of a smartphone application for helping individuals with type 2 diabetes mellitus manage their blood glucose: a trial protocol

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Version 1

Abstract

Figures

Background

Methods

Research question

Study design

Trial registration and ethics compliance

Study sites

Participants

Randomization and interventions

Allocation concealment and blinding

Sample size

Outcomes

Assessments

Statistical analysis

Discussion

Limitations of the trial design

Abbreviations

Declarations

References

Additional Declarations

Supplementary Files

Status:

Version 1