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

NCT ID: NCT06118671

Last Updated: 2023-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

460 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-07

Study Completion Date

2024-11-07

Brief Summary

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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

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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.

Conditions

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Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Intervention group

giving personalized lifestyle intervention suggestions through AI

Group Type EXPERIMENTAL

personalized lifestyle intervention by AI

Intervention Type BEHAVIORAL

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.

Control group

giving routine lifestyle suggestions

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chongqing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Qifu Li

Professor.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jinbo Hu, PhD

Role: STUDY_CHAIR

First Affiliated Hospital of Chongqing Medical University

Locations

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Jinbo Hu

Chongqing, Chongqing Municipality, China

Site Status

Countries

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China

Central Contacts

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Jinbo Hu, PhD

Role: CONTACT

+86 023-89011552

Bing Kang, PhD

Role: CONTACT

+86 023-89011552

Facility Contacts

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Jinbo Hu, PhD

Role: primary

02389011552

References

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Dobson R, Whittaker R, Jiang Y, Maddison R, Shepherd M, McNamara C, Cutfield R, Khanolkar M, Murphy R. Effectiveness of text message based, diabetes self management support programme (SMS4BG): two arm, parallel randomised controlled trial. BMJ. 2018 May 17;361:k1959. doi: 10.1136/bmj.k1959.

Reference Type BACKGROUND
PMID: 29773539 (View on PubMed)

Wu Y, Min H, Li M, Shi Y, Ma A, Han Y, Gan Y, Guo X, Sun X. Effect of Artificial Intelligence-based Health Education Accurately Linking System (AI-HEALS) for Type 2 diabetes self-management: protocol for a mixed-methods study. BMC Public Health. 2023 Jul 11;23(1):1325. doi: 10.1186/s12889-023-16066-z.

Reference Type BACKGROUND
PMID: 37434126 (View on PubMed)

Toi PL, Anothaisintawee T, Chaikledkaew U, Briones JR, Reutrakul S, Thakkinstian A. Preventive Role of Diet Interventions and Dietary Factors in Type 2 Diabetes Mellitus: An Umbrella Review. Nutrients. 2020 Sep 6;12(9):2722. doi: 10.3390/nu12092722.

Reference Type BACKGROUND
PMID: 32899917 (View on PubMed)

Viguiliouk E, Kendall CW, Kahleova H, Rahelic D, Salas-Salvado J, Choo VL, Mejia SB, Stewart SE, Leiter LA, Jenkins DJ, Sievenpiper JL. Effect of vegetarian dietary patterns on cardiometabolic risk factors in diabetes: A systematic review and meta-analysis of randomized controlled trials. Clin Nutr. 2019 Jun;38(3):1133-1145. doi: 10.1016/j.clnu.2018.05.032. Epub 2018 Jun 13.

Reference Type BACKGROUND
PMID: 29960809 (View on PubMed)

Nundy S, Dick JJ, Chou CH, Nocon RS, Chin MH, Peek ME. Mobile phone diabetes project led to improved glycemic control and net savings for Chicago plan participants. Health Aff (Millwood). 2014 Feb;33(2):265-72. doi: 10.1377/hlthaff.2013.0589.

Reference Type BACKGROUND
PMID: 24493770 (View on PubMed)

Arambepola C, Ricci-Cabello I, Manikavasagam P, Roberts N, French DP, Farmer A. The Impact of Automated Brief Messages Promoting Lifestyle Changes Delivered Via Mobile Devices to People with Type 2 Diabetes: A Systematic Literature Review and Meta-Analysis of Controlled Trials. J Med Internet Res. 2016 Apr 19;18(4):e86. doi: 10.2196/jmir.5425.

Reference Type BACKGROUND
PMID: 27095386 (View on PubMed)

Sarkar U, Karter AJ, Liu JY, Adler NE, Nguyen R, Lopez A, Schillinger D. The literacy divide: health literacy and the use of an internet-based patient portal in an integrated health system-results from the diabetes study of northern California (DISTANCE). J Health Commun. 2010;15 Suppl 2(Suppl 2):183-96. doi: 10.1080/10810730.2010.499988.

Reference Type BACKGROUND
PMID: 20845203 (View on PubMed)

Chiavaroli L, Lee D, Ahmed A, Cheung A, Khan TA, Blanco S, Mejia, Mirrahimi A, Jenkins DJA, Livesey G, Wolever TMS, Rahelic D, Kahleova H, Salas-Salvado J, Kendall CWC, Sievenpiper JL. Effect of low glycaemic index or load dietary patterns on glycaemic control and cardiometabolic risk factors in diabetes: systematic review and meta-analysis of randomised controlled trials. BMJ. 2021 Aug 4;374:n1651. doi: 10.1136/bmj.n1651.

Reference Type BACKGROUND
PMID: 34348965 (View on PubMed)

Wagner EH, Sandhu N, Newton KM, McCulloch DK, Ramsey SD, Grothaus LC. Effect of improved glycemic control on health care costs and utilization. JAMA. 2001 Jan 10;285(2):182-9. doi: 10.1001/jama.285.2.182.

Reference Type BACKGROUND
PMID: 11176811 (View on PubMed)

Other Identifiers

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BDT-CDR

Identifier Type: -

Identifier Source: org_study_id

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