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

November 1, 2023 updated by: Qifu Li, Chongqing Medical University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

460

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400016
        • Jinbo Hu
        • Contact:
        • Principal Investigator:
          • Jinbo Hu, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of HbA1c
Time Frame: one year
Change of HbA1c from baseline to endpoint (1 year follow-up)
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of systolic blood pressure
Time Frame: one year
Change of systolic blood pressure from baseline to endpoint
one year
Change of diastolic blood pressure
Time Frame: one year
Reduction of diastolic blood pressure from baseline to endpoint
one year
Change of LDL-c
Time Frame: one year
Change of LDL-c from baseline to endpoint
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chongqing Medical University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 7, 2023

Primary Completion (Estimated)

November 7, 2024

Study Completion (Estimated)

November 7, 2024

Study Registration Dates

First Submitted

October 23, 2023

First Submitted That Met QC Criteria

November 1, 2023

First Posted (Actual)

November 7, 2023

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 1, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • BDT-CDR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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