Condition or disease | Intervention/treatment | Phase |
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Type 1 Diabetes | Behavioral: Automated structured education intervention based on an app and artificial intelligence | Not Applicable |
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 (Clinical Trial) |
Estimated Enrollment : | 138 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Automated Structured Education Intervention Based on an App and Artificial Intelligence in Chinese Patients With Type 1 Diabetes |
Actual Study Start Date : | September 8, 2020 |
Estimated Primary Completion Date : | December 2021 |
Estimated Study Completion Date : | December 2023 |
Arm | Intervention/treatment |
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Experimental: Automated, Individualized Education
Subjects will be given instructions to install the patient-end App, which includes the following functions: diabetes education, patient-doctor communication, diabetes diary, peer support, reminder for blood sugar test and related abnormal results. They receive push notifications that provides recommended education materials which meet the needs of the patient by considering his/her baseline diabetes-related knowledge.
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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.
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No Intervention: Routine care
Subjects only receive the education provided by health-care professionals in the outpatient department
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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Xia Li, MD/PHD | +86 17373199692 | lixia2014@vip.163.com |
China | |
Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University | Recruiting |
Changsha, China, 410011 | |
Contact: Xia Li, MD/PHD +86 17373199692 |
Principal Investigator: | Xia Li, MD/PHD | Central South University |
Tracking Information | |||||
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First Submitted Date ICMJE | July 5, 2019 | ||||
First Posted Date ICMJE | July 12, 2019 | ||||
Last Update Posted Date | September 16, 2020 | ||||
Actual Study Start Date ICMJE | September 8, 2020 | ||||
Estimated Primary Completion Date | December 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
changes in serum hemoglobin A1c level [ Time Frame: from baseline to week 12, 24 ] A1c reflects the average blood glucose level in the past 2-3 months.
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Original Primary Outcome Measures ICMJE |
changes in serum hemoglobin A1c level [ Time Frame: from baseline to week 4, 12, 24 ] A1c reflects the average blood glucose level in the past 2-3 months.
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Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Automated Structured Education Based on an App and AI in Chinese Patients With Type 1 Diabetes | ||||
Official Title ICMJE | Automated Structured Education Intervention Based on an App and Artificial Intelligence in Chinese Patients With Type 1 Diabetes | ||||
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. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Type 1 Diabetes | ||||
Intervention ICMJE | 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.
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Study Arms ICMJE |
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Publications * | Huang F, Wu X, Xie Y, Liu F, Li J, Li X, Zhou Z. An automated structured education intervention based on a smartphone app in Chinese patients with type 1 diabetes: a protocol for a single-blinded randomized controlled trial. Trials. 2020 Nov 23;21(1):944. doi: 10.1186/s13063-020-04835-9. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
138 | ||||
Original Estimated Enrollment ICMJE |
183 | ||||
Estimated Study Completion Date ICMJE | December 2023 | ||||
Estimated Primary Completion Date | December 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 50 Years (Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | China | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04016987 | ||||
Other Study ID Numbers ICMJE | AI App-EC T1D 2019 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Xia Li, Second Xiangya Hospital of Central South University | ||||
Study Sponsor ICMJE | Second Xiangya Hospital of Central South University | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Second Xiangya Hospital of Central South University | ||||
Verification Date | September 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |