Insulin Dose Calculation Software in Insulin Therapy

Artificial Intelligence Clinical Trial

— IDCST  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05389839
• Other study ID #: 21Y11904700
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: September 30, 2024

Study information

• Verified date: October 2022
• Source: Huashan Hospital
• Contact: Xiaolong Zhao, PhD
• Phone: 13501827230
• Email: xiaolongzhao[@]163.con
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 182
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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 < 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

Related Conditions & MeSH terms

• Artificial Intelligence
• Insulin Therapy
• Time in Range

Intervention

Device:
• Wechat program
The experimental group used wechat program to calculate insulin dose to guide insulin treatment .

Locations

Country	Name	City	State
China	Xiaolong Zhao	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
xiaolong zhao

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mean blood glucose	Mean blood glucose	one week
Secondary	above target blood glucose range (TAR) for time or ratio,	above target blood glucose range (TAR) for time or ratio,	one week
Secondary	below target blood glucose range (TBR) for time or Proportion	below target blood glucose range (TBR) for time or Proportion	one week
Secondary	insulin dose	insulin dose	one week
Secondary	hospitalization cost	hospitalization cost	one week
Secondary	hospitalization length of stay	hospitalization length of stay	one week