CClinicalTrials.gg
Status unknownNCT05389839IDCSTUpdated Oct 24, 2022

Insulin Dose Calculation Software in Insulin Therapy

An interventional study of Wechat program in Time in Range, Artificial Intelligence and Insulin Therapy, sponsored by xiaolong zhao. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-10-24.

Sponsored by xiaolong zhao · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Oct 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
182
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Time in Range
  • Artificial Intelligence
  • Insulin Therapy
03

In context

Lead sponsor

xiaolong zhao is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

    1. Non-endocrine departments;
    1. Age 18-70;
    1. Currently using intensive insulin therapy with basic meals;
    1. Belong to type 1 or Type 2 diabetes
    1. Hospitalized patients 6. Regular meals

Exclusion criteria

Exclusion Criteria:

    1. Unwilling to participate or unable to cooperate.
    1. Myocardial infarction or cardiovascular and cerebrovascular events in the last 3 months;
    1. Glomerular filtration rate \< 45 ml/min / 1.73 m2;
    1. Other serious concomitant diseases;
    1. Liver function transaminase is 2 times higher than the upper limit of normal range;
    1. Use of oral hypoglycemic drugs other than metformin
    1. Asymptomatic hypoglycemia
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
182 participants (estimated)

Study arms

  • Experimental
    Wechat program guidance group

    Wechat program guidance group using insulin dose calculator

    Device: Wechat program

  • Active comparator
    clinical experience treatment group

    clinical experience treatment group using physician experience

    Device: Wechat program

Interventions

  • DeviceWechat program

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

06

What researchers measure

Primary outcomes

  1. Subjects in both groups targeted blood glucose range (TIR) time or ratio.

    Subjects in both groups targeted blood glucose range (TIR) time or ratio.

    Time frame: one week

Secondary outcomes

  1. Mean blood glucose

    Mean blood glucose

    Time frame: one week

  2. above target blood glucose range (TAR) for time or ratio,

    above target blood glucose range (TAR) for time or ratio,

    Time frame: one week

  3. below target blood glucose range (TBR) for time or Proportion

    below target blood glucose range (TBR) for time or Proportion

    Time frame: one week

  4. insulin dose

    insulin dose

    Time frame: one week

  5. hospitalization cost

    hospitalization cost

    Time frame: one week

  6. hospitalization length of stay

    hospitalization length of stay

    Time frame: one week

07

Study locations

1 of 1 sites recruiting
  • Xiaolong Zhao
    Shanghai, Shanghai 200041, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 24, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05389839
Lead sponsor
xiaolong zhao
Responsible party
xiaolong zhao (director, Huashan Hospital) — Sponsor-investigator
First posted
May 25, 2022
Start date
Oct 1, 2021
Primary completion
Sep 30, 2024 (estimated)
Completion
Sep 30, 2024 (estimated)
Last update
Oct 24, 2022

Study contacts

Xiaolong Zhao, PhD
Contact
xiaolongzhao@163.con
13501827230
Duoduo Qu, Master
Contact
quduoduonju@163.com
19852812469
Xiaolong Zhao, PhD
study chair · Shanghai Public Health Clinical Center

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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