Automated Structured Education Based on an App and AI in Chinese Patients With Type 1 Diabetes
1 other identifier
interventional
138
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 5, 2019
CompletedFirst Posted
Study publicly available on registry
July 12, 2019
CompletedStudy Start
First participant enrolled
September 8, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedSeptember 16, 2020
September 1, 2020
1.2 years
July 5, 2019
September 13, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (18)
changes in Time in range (TIR)
from baseline to week 12, 24
Chinese version of Diabetes Quality of Life scale
from baseline to week 12, 24
Diabetes Self-Management Scale
from baseline to week 12, 24
Chinese version of Diabetes Self-Care Activities
from baseline to week 12, 24
Diabetes Empowerment Scale-Short Form
from baseline to week 12, 24
- +13 more secondary outcomes
Study Arms (2)
Automated, Individualized Education
EXPERIMENTALSubjects 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.
Routine care
NO INTERVENTIONSubjects only receive the education provided by health-care professionals in the outpatient department
Interventions
In the 24-week intervention period, the experimental group receives automated push notifications supported by artificial intelligent algorithm.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University
Changsha, 410011, China
Related Publications (1)
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.
PMID: 33225982DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xia Li, MD/PHD
Central South University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Department of Endocrinology, Institute of of Metabolism and Endocrinology, Nationa Clinical Research Center for Metabolic Diseases, Second Xiangya Hospital of Central South University
Study Record Dates
First Submitted
July 5, 2019
First Posted
July 12, 2019
Study Start
September 8, 2020
Primary Completion
December 1, 2021
Study Completion
December 1, 2023
Last Updated
September 16, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share