Insulin Dose Calculation Software in Insulin Therapy

NCT ID: NCT05389839

Last Updated: 2022-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

182 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2024-09-30

Brief Summary

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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

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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.

Conditions

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Time in Range Artificial Intelligence Insulin Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Wechat program guidance group

Wechat program guidance group using insulin dose calculator

Group Type EXPERIMENTAL

Wechat program

Intervention Type DEVICE

The experimental group used wechat program to calculate insulin dose to guide insulin treatment .

clinical experience treatment group

clinical experience treatment group using physician experience

Group Type ACTIVE_COMPARATOR

Wechat program

Intervention Type DEVICE

The experimental group used wechat program to calculate insulin dose to guide insulin treatment .

Interventions

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Wechat program

The experimental group used wechat program to calculate insulin dose to guide insulin treatment .

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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xiaolong zhao

OTHER

Sponsor Role lead

Responsible Party

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xiaolong zhao

director

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Xiaolong Zhao, PhD

Role: STUDY_CHAIR

Shanghai Public Health Clinical Center

Locations

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Xiaolong Zhao

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiaolong Zhao, PhD

Role: CONTACT

13501827230

Duoduo Qu, Master

Role: CONTACT

19852812469

Facility Contacts

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Xiaolong Zhao, PhD.

Role: primary

86-18918067241

Duoduo Qu, Master

Role: backup

19852812469

Other Identifiers

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21Y11904700

Identifier Type: -

Identifier Source: org_study_id

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