AI Health Assistant and Type 2 Diabetes

Sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05539066
Collaborator
(none)
196
2
24

Study Details

Study Description

Brief Summary

The developed health assistant has the functions of intelligent analysis of health data inside and outside the hospital, health reminder, etc. The advantages of AI health assistant management group compared with conventional management group in terms of comprehensive compliance rate, metabolic index level, hypoglycemia incidence rate was further studied.

Condition or Disease Intervention/Treatment Phase
  • Device: AI health assistant
N/A

Detailed Description

  1. The investigators have developed an AI health assistant suitable for diabetes patients, which has the functions of automatically uploading blood pressure, blood glucose data, intelligent reminder, automatic analysis of reports inside and outside the hospital, intelligent question and answer, etc. it is simple to operate, highly interactive, and maximizes the management level of diabetes patients outside the hospital.

  2. Through AI personal health assistant, 196 diabetes patients were managed to further improving the comprehensive compliance rate of metabolic indicators such as blood glucose and blood pressure of diabetes patients, improving the patients' self-management ability.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
196 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Application of AI Health Assistant in Out of Hospital Management of Patients With Type 2 Diabetes
Anticipated Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Sep 30, 2024
Anticipated Study Completion Date :
Sep 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: AI health assistant

An AI health assistant suitable for diabetes patients has been developed. It has the functions of automatically uploading blood pressure, blood glucose data, intelligent reminder, automatic analysis of reports inside and outside the hospital, intelligent question and answer, etc. it is simple to operate, highly interactive, and maximizes the management level of diabetes patients outside the hospital.

Device: AI health assistant
To study the advantages of AI health assistant management group compared with conventional management group in terms of comprehensive compliance rate, metabolic index level, hypoglycemia incidence rate, and mastery of diabetes related knowledge.

No Intervention: Routine treatment group

Perform routine management and follow-up without using AI health assistant

Outcome Measures

Primary Outcome Measures

  1. HbA1c compliance rate [6 months]

    Compliance rate of HbA1c < 7%

  2. Blood pressure compliance rate [6 months]

    Proportion of patients with blood pressure < 130 / 80mmHg

  3. Compliance rate of total cholesterol [6 months]

    Proportion of patients with total cholesterol < 4.5mmol/l

  4. Compliance rate of BMI (Body Mass Index) [6 months]

    Proportion of patients with BMI < 24 kg/m2

Secondary Outcome Measures

  1. Incidence of hypoglycemia [6 months]

    Number of attacks with blood glucose less than 3.8mmol/l

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

The diagnostic criteria of T2DM patients are the diagnostic criteria of the 2017 China guidelines for the prevention and treatment of type 2 diabetes HbA1c 7.5-13% Age: 18-65y BMI 18.5-30kg/m2 The course of disease is less than 5 years Have good cognitive ability and can correctly use health assistants

Exclusion Criteria:

Acute complications of diabetes (diabetes ketosis, etc.) Diabetes complicating pregnancy or preparing for pregnancy HbA1c < 7.5% or > 13% Age < 18y or age > 65y Pre pregnancy BMI < 18.5 or > 30kg / m2 Severe liver and kidney dysfunction (ALT greater than 2.5 times the upper limit of normal, EGFR less than 45 ml / min / 1.73m2) Using drugs that may affect blood glucose are being used (including steroids, hydroxyprogesterone hexanoate, anti AIDS drugs, etc.)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Investigators

  • Study Chair: Yufan Wang, doctor, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Liping Gu, Deputy chief physician, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT05539066
Other Study ID Numbers:
  • 21Y11904800
First Posted:
Sep 14, 2022
Last Update Posted:
Sep 14, 2022
Last Verified:
Sep 1, 2022
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 Liping Gu, Deputy chief physician, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 14, 2022