Insulin Dose Calculation Software in Insulin Therapy

Not Applicable

Recruiting

• Conditions: Time in Range; Artificial Intelligence; Insulin Therapy
• Interventions: Device: Wechat program

• Registration Number: NCT05389839
• Lead Sponsor: xiaolong zhao

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.

Study Timeline

• Study Start: 2021-10-01
• Study First Submitted: 2021-10-25
• Study First Submitted QC: 2022-05-21
• Study First Posted: 2022-05-25
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-21
• Last Update Posted: 2022-10-24
• Primary Completion: 2024-09-30
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 182

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Wechat program guidance group	Wechat program	Wechat program guidance group using insulin dose calculator
clinical experience treatment group	Wechat program	clinical experience treatment group using physician experience

Primary Outcome Measures

Name	Time	Method
Subjects in both groups targeted blood glucose range (TIR) time or ratio.	one week	Subjects in both groups targeted blood glucose range (TIR) time or ratio.

Secondary Outcome Measures

Name	Time	Method
Mean blood glucose	one week	Mean blood glucose
above target blood glucose range (TAR) for time or ratio,	one week	above target blood glucose range (TAR) for time or ratio,
below target blood glucose range (TBR) for time or Proportion	one week	below target blood glucose range (TBR) for time or Proportion
insulin dose	one week	insulin dose
hospitalization cost	one week	hospitalization cost
hospitalization length of stay	one week	hospitalization length of stay

Trial Locations

Locations (1)

Xiaolong Zhao; 🇨🇳 Shanghai, Shanghai, China