Automated Structured Education Based on an App and AI in Chinese Patients With Type 1 Diabetes

Type 1 Diabetes Clinical Trial

Official title:

Automated Structured Education Intervention Based on an App and Artificial Intelligence in Chinese Patients With Type 1 Diabetes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04016987
• Other study ID #: AI App-EC T1D 2019
• Status: Recruiting
• Phase: N/A
• Start date: September 8, 2020
• Est. completion date: December 2023

Study information

• Verified date: September 2020
• Source: Second Xiangya Hospital of Central South University
• Contact: Xia Li, MD/PHD
• Phone: +86 17373199692
• Email: lixia2014[@]vip.163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 138
• Est. completion date: December 2023
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Behavioral:
• Automated 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.

Locations

Country	Name	City	State
China	Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University	Changsha

Sponsors (1)

Lead Sponsor	Collaborator
Second Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in serum hemoglobin A1c level	A1c reflects the average blood glucose level in the past 2-3 months.	from baseline to week 12, 24
Secondary	changes in Time in range (TIR)	TIR measures the time where the blood glucose remains within the proposed target range.	from baseline to week 12, 24
Secondary	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.	from baseline to week 12, 24
Secondary	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.	from baseline to week 12, 24
Secondary	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.	from baseline to week 12, 24
Secondary	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.	from baseline to week 12, 24
Secondary	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.	from baseline to week 12, 24
Secondary	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.	from baseline to week 12, 24
Secondary	Fasting blood glucose	the blood sugar level after fasting for eight hours	from baseline to week 12, 24
Secondary	Systolic blood pressure	Systolic blood pressure	from baseline to week 12, 24
Secondary	Diastolic blood pressure	Diastolic blood pressure	from baseline to week 12, 24
Secondary	Total cholesterol	serum total cholesterol level	from baseline to week 12, 24
Secondary	High-density lipoprotein (HDL) cholesterol	serum HDL level	from baseline to week 12, 24
Secondary	Low-density lipoprotein (LDL) cholesterol	serum LDL level	from baseline to week 12, 24
Secondary	Triglycerides	serum triglycerides level	from baseline to week 12, 24
Secondary	Height in meters	Height in meters will be measured.	from baseline to week 12, 24
Secondary	Weight in kilograms	Weight in kilograms will be measured.	from baseline to week 12, 24
Secondary	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.	automatically collected by the app from baseline to week 24
Secondary	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.	every 4 weeks from baseline to week 24