AI Health Assistant and Type 2 Diabetes

Health Behavior Clinical Trial

Official title:

Application of AI Health Assistant in Out of Hospital Management of Patients With Type 2 Diabetes

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05539066
• Other study ID #: 21Y11904800
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: September 30, 2024

Study information

• Verified date: September 2022
• Source: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Liping Gu, doctor
• Phone: +86(021)63240090
• Email: guliping1980[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 196
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Health Behavior
• Type2 Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c compliance rate	Compliance rate of HbA1c < 7%	6 months
Primary	Blood pressure compliance rate	Proportion of patients with blood pressure < 130 / 80mmHg	6 months
Primary	Compliance rate of total cholesterol	Proportion of patients with total cholesterol < 4.5mmol/l	6 months
Primary	Compliance rate of BMI (Body Mass Index)	Proportion of patients with BMI < 24 kg/m2	6 months
Secondary	Incidence of hypoglycemia	Number of attacks with blood glucose less than 3.8mmol/l	6 months