AI Health Assistant and Type 2 Diabetes

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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.

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

Conditions
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Health Behavior, Type2 Diabetes Mellitus

Intervention / Treatment
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* Device: AI health assistant


Participation Criteria
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Eligibility Criteria
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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.)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AI health assistant<br>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<br>* 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.<br>|
| No Intervention: Routine treatment group<br>Perform routine management and follow-up without using AI health assistant | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c compliance rate | Compliance rate of HbA1c < 7% | 6 months | 
| Blood pressure compliance rate | Proportion of patients with blood pressure < 130 / 80mmHg | 6 months | 
| Compliance rate of total cholesterol | Proportion of patients with total cholesterol < 4.5mmol/l | 6 months | 
| Compliance rate of BMI (Body Mass Index) | Proportion of patients with BMI < 24 kg/m2 | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of hypoglycemia | Number of attacks with blood glucose less than 3.8mmol/l | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 Diabetes, AI health assistant, Off hospital management