Type 1 Diabetes
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALAutomated structured education intervention based on an app and artificial intelligence
In the 24-week intervention period, the experimental group receives automated push notifications supported by artificial intelligent algorithm.
Sponsors
Second Xiangya Hospital of Central South University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Individuals diagnosed with Type 1 Diabetes according to the 1999 World Health Organization report * Insulin dependence from disease onset * Aged 18-50 years * With a disease duration over 6 months * With a HbA1c level over 7% * Treated T1DM with multiple daily injections or insulin pump * Individuals who own smartphone and are capable of using wechat or apps
Exclusion criteria
* Age below 18 years or above 50 years * Being pregnant * With mental disorders * Have any other condition or disease that may hamper from compliance with the protocol or complication of the trial * Already using a smartphone app for managing diabetes * Having chronic complications including diabetic retinopathy, diabetic nephropathy or diabetic foot, diabetic neuropathy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| changes in serum hemoglobin A1c level | from baseline to week 12, 24 | A1c reflects the average blood glucose level in the past 2-3 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Chinese version of Diabetes Quality of Life scale | from baseline to week 12, 24 | 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. |
| Diabetes Self-Management Scale | from baseline to week 12, 24 | 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. |
| Chinese version of Diabetes Self-Care Activities | from baseline to week 12, 24 | 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. |
| Diabetes Empowerment Scale-Short Form | from baseline to week 12, 24 | 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. |
| State-Trait Anxiety Inventory (STAI) | from baseline to week 12, 24 | 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. |
| Beck's Depression Inventory (BDI) | from baseline to week 12, 24 | 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. |
| Fasting blood glucose | from baseline to week 12, 24 | the blood sugar level after fasting for eight hours |
| Systolic blood pressure | from baseline to week 12, 24 | Systolic blood pressure |
| changes in Time in range (TIR) | from baseline to week 12, 24 | TIR measures the time where the blood glucose remains within the proposed target range. |
| Total cholesterol | from baseline to week 12, 24 | serum total cholesterol level |
| High-density lipoprotein (HDL) cholesterol | from baseline to week 12, 24 | serum HDL level |
| Low-density lipoprotein (LDL) cholesterol | from baseline to week 12, 24 | serum LDL level |
| Triglycerides | from baseline to week 12, 24 | serum triglycerides level |
| Height in meters | from baseline to week 12, 24 | Height in meters will be measured. |
| Weight in kilograms | from baseline to week 12, 24 | Weight in kilograms will be measured. |
| Patients engagement with the app | automatically collected by the app from baseline to week 24 | 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. |
| Adverse events | every 4 weeks from baseline to week 24 | 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. |
| Diastolic blood pressure | from baseline to week 12, 24 | Diastolic blood pressure |
Countries
China
Contacts
Primary ContactXia Li, MD/PHD
Outcome results
None listed