Insulin Dose Calculation Software in Insulin Therapy (IDCST)

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

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 Overview

• Status: Recruiting
• Conditions: Artificial Intelligence; Time in Range; Insulin Therapy
• Intervention / Treatment: Device: Wechat program

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 Type: Interventional
• Enrollment (Anticipated): 182
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiaolong Zhao, PhD; Phone Number: 13501827230; Email: xiaolongzhao@163.con
• Study Contact Backup: Name: Duoduo Qu, master; Phone Number: 19852812469; Email: quduoduonju@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200041
      • Recruiting
      • Xiaolong Zhao
      • Contact: Duoduo Qu, master; Phone Number: 19852812469; Email: quduoduonju@163.com
      • Contact: Xiaolong Zhao, PhD.; Phone Number: 86-18918067241; Email: xiaolongzhao@163.com
      • Principal Investigator: Xiaolong Zhao, PhD.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: xiaolong zhao
• Investigators: Study Chair: Xiaolong Zhao, PhD, Shanghai Public Health Clinical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Anticipated): September 30, 2024
• Study Completion (Anticipated): September 30, 2024

Study Registration Dates

• First Submitted: October 25, 2021
• First Submitted That Met QC Criteria: May 21, 2022
• First Posted (Actual): May 25, 2022

Study Record Updates

• Last Update Posted (Actual): October 24, 2022
• Last Update Submitted That Met QC Criteria: October 21, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 21Y11904700

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No