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Clinical Trials/NCT06118671
NCT06118671
Not Yet Recruiting
N/A

Application and Effectiveness Evaluation of Artificial Intelligence in Lifestyle Management of Diabetic Patients of Community

Chongqing Medical University1 site in 1 country460 target enrollmentNovember 7, 2023
ConditionsDiabetes

Overview

Phase
N/A
Intervention
Not specified
Conditions
Diabetes
Sponsor
Chongqing Medical University
Enrollment
460
Locations
1
Primary Endpoint
Change of HbA1c
Status
Not Yet Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 7, 2023
End Date
November 7, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Chongqing Medical University
Responsible Party
Principal Investigator
Principal Investigator

Qifu Li

Professor.

Chongqing Medical University

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

Outcomes

Primary Outcomes

Change of HbA1c

Time Frame: one year

Change of HbA1c from baseline to endpoint (1 year follow-up)

Secondary Outcomes

  • Change of systolic blood pressure(one year)
  • Change of diastolic blood pressure(one year)
  • Change of LDL-c(one year)

Study Sites (1)

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