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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05389839
Other study ID # 21Y11904700
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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