The Evaluation of Artificial Intelligence in Lifestyle Management of Diabetic Patients in Community

Sponsor
Chongqing Medical University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06118671
Collaborator
(none)
460
1
2
12
38.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: personalized lifestyle intervention by AI
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
460 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Other
Official Title:
Application and Effectiveness Evaluation of Artificial Intelligence in Lifestyle Management of Diabetic Patients of Community
Anticipated Study Start Date :
Nov 7, 2023
Anticipated Primary Completion Date :
Nov 7, 2024
Anticipated Study Completion Date :
Nov 7, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention group

giving personalized lifestyle intervention suggestions through AI

Behavioral: personalized lifestyle intervention by AI
The experimental group completed 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.

No Intervention: Control group

giving routine lifestyle suggestions

Outcome Measures

Primary Outcome Measures

  1. Change of HbA1c [one year]

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

Secondary Outcome Measures

  1. Change of systolic blood pressure [one year]

    Change of systolic blood pressure from baseline to endpoint

  2. Change of diastolic blood pressure [one year]

    Reduction of diastolic blood pressure from baseline to endpoint

  3. Change of LDL-c [one year]

    Change of LDL-c from baseline to endpoint

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Jinbo Hu Chongqing Chongqing China 400016

Sponsors and Collaborators

  • Chongqing Medical University

Investigators

  • Study Chair: Jinbo Hu, PhD, First Affiliated Hospital of Chongqing Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Qifu Li, Professor., Chongqing Medical University
ClinicalTrials.gov Identifier:
NCT06118671
Other Study ID Numbers:
  • BDT-CDR
First Posted:
Nov 7, 2023
Last Update Posted:
Nov 7, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Qifu Li, Professor., Chongqing Medical University

Study Results

No Results Posted as of Nov 7, 2023