Time in RangeIDCSTNCT05389839
Insulin Dose Calculation Software in Insulin Therapy
A study testing Wechat program in people with Time in Range and Artificial Intelligence, run by xiaolong zhao at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Time in Range, Artificial Intelligence, Insulin Therapy
- What is being tested?
- Wechat program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2021to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xiaolong Zhao
Shanghai, Shanghai Municipality, 200041
Xiaolong Zhao, PhD., 86-18918067241, xiaolongzhao@163.com
Duoduo Qu, Master, 19852812469, quduoduonju@163.com
About this study
Official title: Application of Intelligent Insulin Dose Calculation Software in Patients With Insulin Therapy：A Randomized Controlled Intervention Trial
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.
- Conditions
- Time in Range, Artificial Intelligence, Insulin Therapy
- Being tested
- Wechat program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wechat programDevice
The experimental group used wechat program to calculate insulin dose to guide insulin treatment .
| Study group | Role | What they receive |
|---|---|---|
| Wechat program guidance group | Experimental | Wechat program guidance group using insulin dose calculator Receives: Device: Wechat program |
| clinical experience treatment group | Active comparator | clinical experience treatment group using physician experience Receives: Device: Wechat program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjects in both groups targeted blood glucose range (TIR) time or ratio.
Subjects in both groups targeted blood glucose range (TIR) time or ratio.
Measured: one week
Secondary outcomes (6)
Mean blood glucose
Mean blood glucose
Measured: one week
above target blood glucose range (TAR) for time or ratio,
above target blood glucose range (TAR) for time or ratio,
Measured: one week
below target blood glucose range (TBR) for time or Proportion
below target blood glucose range (TBR) for time or Proportion
Measured: one week
insulin dose
insulin dose
Measured: one week
hospitalization cost
hospitalization cost
Measured: one week
hospitalization length of stay
hospitalization length of stay
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start1 Oct 2021
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Time in RangeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 182 participants (estimated)
Sponsor and investigators
- Lead sponsor
- xiaolong zhao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, xiaolong zhao, Huashan Hospital
- Investigators
- Xiaolong Zhao, PhD, Study chair, Shanghai Public Health Clinical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05389839
- Sponsor's protocol ID
- 21Y11904700
- Acronym
- IDCST
- Status last verified
- Oct 2022
- First submitted
- 25 Oct 2021
- Last updated
- 24 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhou L, Wu C, Wang C, Yu X, Qu D, Yang Y, Xu X, Liu J, Zhu Q, Liao X, Zhao X. Smart insulin dosage software based on trend arrows: an effective method for controlling hyperglycemia in hospitalized diabetic patients in non-endocrine departments (a randomized controlled trial). Endocrine. 2026 Feb 16;91(1):86. doi: 10.1007/s12020-025-04509-z.
PubMed 41697460
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Intelligent Insulin Dose Calculation Software in Patients With Insulin Therapy：A Randomized Controlled Intervention Trial
- ClinicalTrials.gov ID
- NCT05389839
- Acronym / sponsor ID
- IDCST / 21Y11904700
- Conditions
- Time in Range, Artificial Intelligence, Insulin Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 182 participants (estimated)
- Lead sponsor
- xiaolong zhaoUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 25 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wechat program guidance group | Experimental | Device: Wechat programWechat program guidance group using insulin dose calculator |
| clinical experience treatment group | Active comparator | Device: Wechat programclinical experience treatment group using physician experience |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wechat programThe experimental group used wechat program to calculate insulin dose to guide insulin treatment . | Device | Wechat program guidance group, clinical experience treatment group |
Primary outcome
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.
6 secondary outcomes
Mean blood glucose
Time frame: one week
above target blood glucose range (TAR) for time or ratio,
Time frame: one week
below target blood glucose range (TBR) for time or Proportion
Time frame: one week
insulin dose
Time frame: one week
hospitalization cost
Time frame: one week
hospitalization length of stay
Time frame: one week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2022.
- Derived from this study: PubMed 41697460Zhou L, Wu C, Wang C, Yu X, Qu D, Yang Y, Xu X, Liu J, Zhu Q, Liao X, Zhao X. Smart insulin dosage software based on trend arrows: an effective method for controlling hyperglycemia in hospitalized diabetic patients in non-endocrine departments (a randomized controlled trial). Endocrine. 2026 Feb 16;91(1):86. doi: 10.1007/s12020-025-04509-z.
Related trials for Time in Range
Active, not recruitingPhase 4
Diabetes in African Youth
type1diabetes
Recruiting
Clinical Study to Evaluate the Impact of the Accu-Chek SmartGuide CGM Solution on the Mean Change in Time in Range Compared With Self-Monitoring of Blood Glucose in Participants With Type 1 and Type 2 Diabetes Mellitus
Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
Recruiting
Fueling Labor: Protein Supplementation for Intrapartum Glucose Control
Diabetes During Pregnancy
Not yet recruitingObservational study
Warfarin Quality, Adherence, Range, Determinants, and Events in Egyptian Rheumatic Heart Disease and Atrial Fibrillation
AF
Recruiting
Effect of Different Carbohydrate Intake Patterns on Glycemic Control in Patients With Type 1 Diabetes
Type 1 Diabetes, Diet Intervention
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaolong Zhao, PhD study chair
Shanghai Public Health Clinical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wechat program in people with Time in Range and Artificial Intelligence, run by xiaolong zhao at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaolong Zhao, PhD (13501827230, xiaolongzhao@163.con), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjects in both groups targeted blood glucose range (TIR) time or ratio. (time frame: one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05389839, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2022.