Clinical trial NCT06118671: The Evaluation of Artificial Intelligence in Lifestyle Management of Diabetic Patients in Community
Official title: Application and Effectiveness Evaluation of Artificial Intelligence in Lifestyle Management of Diabetic Patients of Community
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diabetes
Keywords: lifestyle intervention
artificial intelligence
Lead sponsor: Chongqing Medical University
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 460
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The goal of this clinical trial is to learn about the application and effectiveness evaluation of artificial intelligence (AI) in lifestyle management of diabetic patients in community.

Detailed description: To determine the effectiveness of lifestyle intervention through AI on diabetic patients, whether it can improve blood sugar/ blood pressure/ body weight/ blood lipid control in people with type 1 or type 2 diabetes? Then find related risk factors. Participants will complete the basic information, diet structure, use of dietary supplements, living habits, and exercise according to the AI scale (AI scale can be entered through we-chat mini program search), and provided personalized lifestyle intervention plan according to the survey result, while the control group received routine lifestyle guidance. All included patients would fill in the patient's medication information according to the information content of the machine reading card, and follow up whether the medication is adjusted. The patient was included in the diabetes management we-chat group, followed up for 3 months /6 months according to the visit plan. The experimental group filled in the lifestyle assessment scale again, and personalized lifestyle intervention programs were provided according to the survey results, while the control group received routine follow-up and lifestyle guidance. Researchers will compare the two groups to see if the control of blood glucose, blood pressure, blood lipids and BMI of the experimental group after 6 months of AI-based lifestyle intervention was better than the control group.

Eligibility criteria: Inclusion Criteria:

* Well informed of the procedures of this trial and informed consent is obtained
* 18-80 years old, gender is not limited
* Diagnosed diabetes (according to WHO1999 diagnostic criteria)
* Well compliance

Exclusion Criteria:

* Pregnant or lactating
* Poor blood glucose control (HbA1c\>11%)
* A history of malignant tumor
* Abnormal liver or renal function \[defined as alanine aminotransferase (ALT)\>2.5 times higher than normal range, or eGFR\<30 mL/min per 1.73 m2\]
* Poor blood pressure control \[systolic blood pressure (SBP)\>180mmHg, or diastolic blood pressure (DBP)\>110mmHg
* With severe heart disease, cardiac function worse than grade II, anemia (Hb\<9.0g/d1)
* Blood routine test indicates that the white blood cell count (WBC) \<3\*109/L
* Body Mass Index (BMI)\<18.5 or ≥35kg/m2
* Drug or alcohol abuse
* Accompanying mental disorder who can't collaborate
* Abnormal digestion and absorption function
* Other endocrine diseases
* Other chronic diseases needed long-term glucocorticoid treatment
* With severe infection, immune dysfunction

Primary outcomes:
measure: Change of HbA1c
timeFrame: one year
Secondary outcomes:
measure: Change of systolic blood pressure
timeFrame: one year
measure: Change of diastolic blood pressure
timeFrame: one year
measure: Change of LDL-c
timeFrame: one year
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Jinbo Hu
state: Chongqing
Study officials:
affiliation: First Affiliated Hospital of Chongqing Medical University
name: Jinbo Hu, PhD
role: STUDY_CHAIR
References:
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