Insulin Dose Calculation Software in Insulin Therapy

Study Overview
=================
Brief Summary
-----------------
Insulin therapy is the mainstream glucose-lowering program for hospital glucose management. Intelligent insulin dose calculation software based on fingertip glucose monitoring is born in response to the situation. A new generation of continuous blood glucose monitoring technology compared with traditional monitoring technology provides more abundant blood sugar change information.The development of the continuous glucose monitoring technology espcially in blood sugar change trend arrow information, the intelligent insulin dose adjustment sequence based on WeChat program is developed. We plan to carry out a randomized controlled study on patients receiving insulin therapy, in which the insulin dose is adjusted according to the information of four blood glucose monitoring points (before meals and before bed), and randomly divided into two groups, one group is adjusted according to the experience of clinicians, the other group is adjusted according to Wechat program, and glucose monitoring is continued for 1 week. bBood glucose control index of TIR , and the incidence of hypoglycemia and hyperglycemia, hospitalization days and cost was observed. This study ihas great clinical value.

Detailed Description
-----------------
The problems related to blood glucose in non-endocrine departments are becoming more and more serious.Glucose control level is closely related to the prognosis and cost of inpatients. Insulin therapy is the mainstream glucose-lowering program for hospital glucose management. Intelligent insulin dose calculation software based on fingertip glucose monitoring is born in response to the situation. A new generation of continuous blood glucose monitoring technology compared with traditional monitoring technology provides more abundant blood sugar change information.The development of the continuous glucose monitoring technology espcially in blood sugar change trend arrow information, the intelligent insulin dose adjustment sequence based on WeChat program is developed. We plan to carry out a randomized controlled study on patients receiving insulin therapy, in which the insulin dose is adjusted according to the information of four blood glucose monitoring points (before meals and before bed), and randomly divided into two groups, one group is adjusted according to the experience of clinicians, the other group is adjusted according to Wechat program, and glucose monitoring is continued for 1 week. bBood glucose control index of TIR , and the incidence of hypoglycemia and hyperglycemia, hospitalization days and cost was observed. This study ihas great clinical value.

Official Title
-----------------
Application of Intelligent Insulin Dose Calculation Software in Patients With Insulin Therapy：A Randomized Controlled Intervention Trial

Conditions
-----------------
Time in Range, Artificial Intelligence, Insulin Therapy

Intervention / Treatment
-----------------
* Device: Wechat program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Non-endocrine departments; 2. Age 18-70; 3. Currently using intensive insulin therapy with basic meals; 4. Belong to type 1 or Type 2 diabetes 5. Hospitalized patients 6. Regular meals Exclusion Criteria: 1. Unwilling to participate or unable to cooperate. 2. Myocardial infarction or cardiovascular and cerebrovascular events in the last 3 months; 3. Glomerular filtration rate &lt; 45 ml/min / 1.73 m2; 4. Other serious concomitant diseases; 5. Liver function transaminase is 2 times higher than the upper limit of normal range; 6. Use of oral hypoglycemic drugs other than metformin 7. Asymptomatic hypoglycemia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Wechat program guidance group<br>Wechat program guidance group using insulin dose calculator | Device: Wechat program<br>* The experimental group used wechat program to calculate insulin dose to guide insulin treatment .<br>|
| Active Comparator: clinical experience treatment group<br>clinical experience treatment group using physician experience | Device: Wechat program<br>* The experimental group used wechat program to calculate insulin dose to guide insulin treatment .<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjects in both groups targeted blood glucose range (TIR) time or ratio. | Subjects in both groups targeted blood glucose range (TIR) time or ratio. | one week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean blood glucose | Mean blood glucose | one week | 
| above target blood glucose range (TAR) for time or ratio, | above target blood glucose range (TAR) for time or ratio, | one week | 
| below target blood glucose range (TBR) for time or Proportion | below target blood glucose range (TBR) for time or Proportion | one week | 
| insulin dose | insulin dose | one week | 
| hospitalization cost | hospitalization cost | one week | 
| hospitalization length of stay | hospitalization length of stay | one week |