In recent years, more and more attention has been paid to diabetes self-management. Glycemic control and self-management skills of patients with type 1 diabetes (T1DM) in China are poor. Artificial intelligence (AI) and the Internet offer a new way to improve the self-management skills of patients with chronic diseases. Few studies have combined AI technology with structured education intervention of type 1 diabetes. This study is innovative in that it compares the effectiveness of smartphone app between usual care, as well as automatic and individualized app education and standardized app education to explore whether the individualized treatment advocated by the latest guideline will bring any additional benefit to T1DM patients. The ultimate goal is to provide an effective and convenient approach for glycemic control of type 1 diabetes and reduce related disease burden in China.
This is a single-blinded, 1:1 paralleled group cluster randomized controlled trial (RCT). The intervention will last for 24 weeks. The laboratory staff who test the HbA1c level, the outcome assessor who collects the blood glucose data, and the statisticians will be blinded to the treatment allocation. Sample size estimation: We propose to enroll 138 patients with type 1 diabetes (T1DM) by considering withdrawals, 69 in the smartphone app groups and 69 in the routine care group. Sample size estimation is based on hypothesized changes in the primary outcome HbA1c. In order to ensure high quality data, two staff are responsible for the input of original data into the database to check and confirm the accuracy. When the data entered by two staff independently, the auxiliary staff decides which data to use. Data analysis will be conducted under the intention-to-treat principle by including all the randomized patients in the data analysis. Missing data will be filled in with multiple imputation method. Any substantial difference in baseline characteristics will be adjusted with mixed-model regression analysis. Sensitivity analysis will be conducted by using per-protocol data by excluding those patients who drop out of the RCT.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
138
In the 24-week intervention period, the experimental group receives automated push notifications supported by artificial intelligent algorithm.
Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University
Changsha, China
RECRUITINGchanges in serum hemoglobin A1c level
A1c reflects the average blood glucose level in the past 2-3 months.
Time frame: from baseline to week 12, 24
changes in Time in range (TIR)
TIR measures the time where the blood glucose remains within the proposed target range.
Time frame: from baseline to week 12, 24
Chinese version of Diabetes Quality of Life scale
Diabetes Quality of Life scale (DQOL) is a wildly used 46-item tool for assessing the quality of life related to diabetes in three aspects: diabetes satisfaction (15 items), impact (20 items), and worry (11 items). Each item is responded to on a 5-point Likert scale, with score of 1 represents "always affected", "always worried", or "never satisfied" and a score of 5 indicates "no impact", "no worries", or "always satisfied". Higher total score reflects better quality of life. A Chinese version of DQOL has been translated and validated in the diabetic population from Mainland China and will be adopted in this trial.
Time frame: from baseline to week 12, 24
Diabetes Self-Management Scale
Diabetes Self-Management Scale is used to assess diabetes self-management behaviors. This scale contains six aspects with a total of 14 items: dietary management, physical activity, self-monitoring of blood sugar, medical treatment, foot care and smoking. Except for smoking, the other five aspects with 11 items ask the number of days during the last week (ie. how many days did you test your blood sugar during the last 7 days?...). One of the dietary questions (ie. days of high-fat diet consumption) is reversely scored (the more days the fewer score), and the rest are positively scored in 0-7 points. The overall score uses the above five aspects of 11 questions, with a minimum score of 0 and maximum score of 77. Higher score reflects better the self-management behaviors.
Time frame: from baseline to week 12, 24
Chinese version of Diabetes Self-Care Activities
Diabetes Self-Care Activities (SDSCA) is used to assess diabetes self-care behavior. This scale contains six behavior related scales: general dietary, specific dietary, glucose monitoring, physical activity, foot care, and smoking. Absolute weekly frequency or consistency of diabetes self-care activities are scored with a 0-7 ranged scale, with higher scores reflecting better performance in self-care behaviors. The internal consistency reliability and construct validity of SDSCA was supported by its psychometric test based on an adult diabetes population. A validated Chinese version of the SDSCA (C-SDSCA) is available for this trial.
Time frame: from baseline to week 12, 24
Diabetes Empowerment Scale-Short Form
Patients' diabetes-related psychosocial self-efficacy will be evaluated with the Diabetes Empowerment Scale-Short Form, which was a short form of Diabetes Empowerment Scale developed from the America population with type 1 or type 2 diabetes. A revised Chinese version is available for the Mainland China population. The Chinese version DES-SF includes 8 domains with 1 item for each (i.e., assessing the need for change, developing a plan, overcoming barriers, asking for support, supporting oneself, coping with emotion, motivating oneself, and making diabetes care choices appropriate for one's priorities and circumstances). Each item is responded on a 5-point Likert scale, with 1 indicating strongly disagree and 5 indicating strongly agree. Total score ranges from 8 to 40, with higher scores reflect a better psychosocial self-efficacy.
Time frame: from baseline to week 12, 24
State-Trait Anxiety Inventory (STAI)
State-Trait Anxiety Inventory (STAI) is used for assessing patients psychological status. The Chinese version STAI consists of two sub-scales to measure both state and trait anxiety states. Each of the two anxiety states will be measured with a 20-item sub-scale, and each item will be scored from 1 to 4. The total score for both state and trait anxiety range from 20 to 80, with high scores indicating more serious anxiety.
Time frame: from baseline to week 12, 24
Beck's Depression Inventory (BDI)
Beck's Depression Inventory (BDI) is used for assessing patients psychological status. The Chinese version BDI (CBDI) consists of 21 self-rated items. Each item will be scored from 0 to 3, with the total score ranges from 0 to 63, and a higher score indicates more serious depression.
Time frame: from baseline to week 12, 24
Fasting blood glucose
the blood sugar level after fasting for eight hours
Time frame: from baseline to week 12, 24
Systolic blood pressure
Systolic blood pressure
Time frame: from baseline to week 12, 24
Diastolic blood pressure
Diastolic blood pressure
Time frame: from baseline to week 12, 24
Total cholesterol
serum total cholesterol level
Time frame: from baseline to week 12, 24
High-density lipoprotein (HDL) cholesterol
serum HDL level
Time frame: from baseline to week 12, 24
Low-density lipoprotein (LDL) cholesterol
serum LDL level
Time frame: from baseline to week 12, 24
Triglycerides
serum triglycerides level
Time frame: from baseline to week 12, 24
Height in meters
Height in meters will be measured.
Time frame: from baseline to week 12, 24
Weight in kilograms
Weight in kilograms will be measured.
Time frame: from baseline to week 12, 24
Patients engagement with the app
Patients' engagement with the app will be measured in terms of communications with the clinician and the utilization of the smartphone app. Specifically, the number of messages sent to patients, the number of message responses, the number of video calls/phone calls with patients, the number of logs entered by patients, and time spent in the health education module will be collected.
Time frame: automatically collected by the app from baseline to week 24
Adverse events
Safety-related outcomes including hypoglycemic events, hospitalization, and emergency room visits will be collected at each follow-up time point including the monthly telephone interview.
Time frame: every 4 weeks from baseline to week 24
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