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Clinical Trials/NCT05389839
NCT05389839RecruitingNot Applicable

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

xiaolong zhao1 site in 1 country182 target enrollmentStarted: October 1, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
182
Locations
1
Primary Endpoint
Subjects in both groups targeted blood glucose range (TIR) time or ratio.

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

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

Time Frame: one week

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

Secondary Outcomes

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

Investigators

Sponsor
xiaolong zhao
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

xiaolong zhao

director

Huashan Hospital

Study Sites (1)

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