Clinical trial NCT05389839: Insulin Dose Calculation Software in Insulin Therapy
Official title: Application of Intelligent Insulin Dose Calculation Software in Patients With Insulin Therapy：A Randomized Controlled Intervention Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Time in Range
Artificial Intelligence
Insulin Therapy
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2022-05-25
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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 \&lt; 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

Primary outcomes:
measure: Subjects in both groups targeted blood glucose range (TIR) time or ratio.
timeFrame: one week
Secondary outcomes:
measure: Mean blood glucose
timeFrame: one week
measure: above target blood glucose range (TAR) for time or ratio,
timeFrame: one week
measure: below target blood glucose range (TBR) for time or Proportion
timeFrame: one week
measure: insulin dose
timeFrame: one week
measure: hospitalization cost
timeFrame: one week
measure: hospitalization length of stay
timeFrame: one week
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xiaolong Zhao
state: Shanghai
Study officials:
affiliation: Shanghai Public Health Clinical Center
name: Xiaolong Zhao, PhD
role: STUDY_CHAIR
References: