NCT05389839

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
182

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2021

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

October 25, 2021

Completed
7 months until next milestone

First Posted

Study publicly available on registry

May 25, 2022

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

October 24, 2022

Status Verified

October 1, 2022

Enrollment Period

3 years

First QC Date

October 25, 2021

Last Update Submit

October 21, 2022

Conditions

Time in RangeArtificial IntelligenceInsulin Therapy

Outcome Measures

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.

    one week

Secondary Outcomes (6)

  • Mean blood glucose

    one week

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

    one week

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

    one week

  • insulin dose

    one week

  • hospitalization cost

    one week

  • +1 more secondary outcomes

Study Arms (2)

Wechat program guidance group

EXPERIMENTAL

Wechat program guidance group using insulin dose calculator

Device: Wechat program

clinical experience treatment group

ACTIVE COMPARATOR

clinical experience treatment group using physician experience

Device: Wechat program

Interventions

Wechat programDEVICE

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

Wechat program guidance groupclinical experience treatment group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xiaolong Zhao

Shanghai, Shanghai Municipality, 200041, China

RECRUITING

Study Officials

  • Xiaolong Zhao, PhD

    Shanghai Public Health Clinical Center

    STUDY CHAIR

Central Study Contacts

Xiaolong Zhao, PhD

CONTACT

13501827230xiaolongzhao@163.con

Duoduo Qu, Master

CONTACT

19852812469quduoduonju@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
director

Study Record Dates

First Submitted

October 25, 2021

First Posted

May 25, 2022

Study Start

October 1, 2021

Primary Completion

September 30, 2024

Study Completion

September 30, 2024

Last Updated

October 24, 2022

Record last verified: 2022-10

Locations

CN(1)