Diabetes MellitusNCT07066891
Validation of Insulin Dose Prediction Model Based on Artificial Intelligence Algorithm
A study testing CSII in the prediction model group and CSII in the empirical group in people with Diabetes Mellitus and Type 2 Diabetes, run by Sun Yat-sen University at 1 site in China.
Trial summary
The present study aims to conduct a prospective controlled trial comparing an LSTM-based artificial intelligence (AI) prediction model and clinicians' experience in the efficacy and safety of blood glucose control in hospitalized patients with type 2 diabetes mellitus (T2DM) receiving continuous subcutaneous insulin… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2 Diabetes
- What is being tested?
- CSII in the prediction model group and CSII in the empirical group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 203 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2025to 4 Feb 2026
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets the diagnostic criteria of type 2 diabetes mellitus in the Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes (2020 edition).
- Insulin pump is used to control blood glucose during hospitalization, and the duration of CSII treatment period ≥6 days and <30 days.
Who cannot join
- Diabetes other than type 2.
- Age ≥75 years who is not suitable for intensive insulin therapy.
- Hypoglycemic regimen other than CSII treatment, such as oral hypoglycemic drugs or multiple daily insulin injections during hospitalization.
- With severe infection or uncontrolled acute complications (including ketoacidosis coma, hyperosmolar hyperglycemia, etc.) , or any condition that the researcher believes not suitable for the study.
- Severe hepatic and renal insufficiency (ALT≥5 times the upper limit of normal, eGFR<30ml/min/1.73m2) ), or patients at the acute stage of cardiovascular and cerebrovascular diseases considered unsuitable for study.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Endocrinology and Diabetes Center, The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510080
About this study
Official title: Validation of Insulin Dose Prediction Model Based on Long Short- Term Memory Artificial Intelligence Algorithm
The present study aims to conduct a prospective controlled trial comparing an LSTM-based artificial intelligence (AI) prediction model and clinicians' experience in the efficacy and safety of blood glucose control in hospitalized patients with type 2 diabetes mellitus (T2DM) receiving continuous subcutaneous insulin infusion (CSII) treatment in the Department of Endocrinology. The main question it aims to answer is:
Is the prediction model superior to or (at least) non-inferior to clinicians' experience?
Read more
Eligible patients who receive CSII treatment are randomly allocated into the prediction model group and the empirical group. Patients will:
- Receive CSII treatment as standard of care during hospitalization for 1-2 weeks, where the daily insulin dose regimen is determined by a prediction model or a clinician's experience.
- Use continuous glucose monitoring (CGM) for glucose tracking.
- Receive diabetes self-management education covering nutrition and physical activity.
Read the detailed description
Data-driven artificial intelligence (AI) represents a new frontier in the modern medical field. The research group previously constructed a database included over 20 years clinical data of short-term intensive insulin therapy (SIIT) via continuous subcutaneous insulin infusion (CSII) in hospitalized patients with type 2 diabetes.The researchers had trained an insulin dose prediction model based on the database using long short-term memory (LSTM) AI algorithms. To establish more robust evidence to validate the efficacy and safety for this model, the present study aims to conduct a pilot prospective controlled trial comparing between AI prediction model and clinician's experience. Specifically, a randomized controlled trial is performed to compare the efficacy and safety of blood glucose control between the insulin dose prediction model and physicians' subjective experience in hospitalized patients with type 2 diabetes mellitus (T2DM) receiving CSII treatment in the Department of Endocrinology. A random number table of 400 participants will be generated using Excel, and randomly allocated into the prediction model group (n=200) and the empirical group (n=200). Medical data will be collected for all the enrolled patients, including medical history, physical examination, auxiliary test reports, continuous glucose monitoring (CGM) data, in which 8 points of the blood glucose (before and 2 hours- postprandial of the 3 main meals, bedtime, and 3 a.m. in the morning) are specifically collected to feed the model for prediction and used for comparisons. For the prediction model group, baseline information upon admission (including age, body mass index [BMI], weight, waist circumference, fasting blood glucose before admission and glycated hemoglobin) is put into the model, which will immediately return the insulin dosage (basal rate and boluses for each meal) for the first day of the insulin pump treatment. Physicians will then issue and execute these orders. On the following days, the model adjust the basal rate and boluses based on the previous day's glucose levels and insulin dosages. This process will continue iteratively during the whole CSII period (around 1 to 2 weeks based on whether or not the patient is newly diagnosed or with different disease durations). Insulin pump will be suspended after the administration of dinner bolus on the final day. Fasting blood glucose on the next day after insulin pump suspension will be recorded to conclude the study. In the control (emperical) group, physicians (residents under the guidance of attending doctors) determine insulin dosage based on individual clinical experience and daily glucose monitoring, with patient data collection identical to the prediction model group. Statistical analyses comparing between-group differences in glucose control during CSII treatment, such as time in range (TIR), time below range (TBR), mean blood glucose, glycemic variability, and post-therapy fasting glucose, insulin doses, etc to evaluate the efficacy and saftey of the two insulin dosage determination methods.
- Conditions
- Diabetes Mellitus, Type 2 Diabetes
- Being tested
- CSII in the prediction model group, CSII in the empirical group
- Keywords
- long short-term memory, type 2 diabetes mellitus, continuous subcutaneous insulin infusion, intensive insulin therapy, insulin dose prediction model
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSII in the prediction model groupDrug
- Everyday insulin dosage decided by AI prediction model.
- CSII treatment continues for 1 to 2 weeks based on whehter or not the patient is newly diagnosed or with different disease duration.
CSII in the empirical groupDrug
- Everyday insulin dosage decided by clinicans' experience.
- CSII treatment continues for 1 to 2 weeks based on whether or not the patient is newly diagnosed or with different disease duration.
| Study group | Role | What they receive |
|---|---|---|
| Prediction model group | Experimental | For the prediction model group, baseline information upon admission (including age, gender, body mass index [BMI], weight, waist circumference, fasting blood glucose before admission, glycated hemoglobin) will be put into the model, which will immediately return the insulin dosage for the first day of insulin pump treatment (basal rate and boluses of each meal). Physicians will then issue and execute these orders. On the following days, the model will adjust the basal rate and the boluses based on the blood glucose level on the previous day and the insulin dosages. This process continue iteratively for the whole CSII treatment period (about 1 to 2 weeks based on whether or not the patient is newly diagnosed or with different disease duration). The insulin pump is suspended after the administration of dinner bolus on the final day. Fasting blood glucose on the next day after insulin pump suspension will be recorded to conclude the study. Receives: Drug: CSII in the prediction model group |
| Empirical group | Active comparator | During the CSII treatment, clinicians (mainly residents under the guidance of attending doctors) determine the everyday insulin dosages based on clinical experience and daily glucose monitoring, with patient data collection identical to the experimental group. Receives: Drug: CSII in the empirical group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in range
Time in range refers to the percentage time in range between 3.9mmol/L and 10.0 mmol/L in continuous glucose monitoring data during the continuous subcutaneous insulin infusion treatment period.
Measured: During continuous subcutaneous insulin infusion treatment period（assessed up to 2 weeks, the treatment period between the initiation and suspension of the insulin pump)
Time below range
Time below range refers to percentage time of glucose<3.9mmol/L in continuous glucose monitoring data during the continuous subcutaneous insulin infusion treatment period.
Measured: During continuous subcutaneous insulin infusion treatment period（assessed up to 2 weeks, the treatment period between the initiation and suspension of the insulin pump)
Secondary outcomes (2)
Post-therapy fasting blood glucose
Insulin pump is suspended after administration of dinner bolus on the final day of continuous subcutaneous insulin infusion treatment. Fasting blood glucose is collected on the next moning before breakfast (12 hours after insulin pump suspension).
Measured: 12 hours after insulin pump suspension.
HbA1c at 3 months after discharge
Patients are followed at 3 months after discharge from hospital, glycated hemoglobin A1c is collected during the visit.
Measured: 3 months after discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start15 Jul 2025
- Primary completion5 Dec 2025
- Study completion4 Feb 2026
Why it stopped: Recruitment was stopped early because hospital length-of-stay constraints limited protocol delivery. The PI's decision also took account of the available non-inferiority results.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The insulin dose prediction model is constructed based on the database from the investigator's department, included all the type 2 diabetes mellitus (T2DM) patients who underwent short-term CSII therapy over the past 20 years. By combining patients' clinical characteristics, the investigators have input the daily capillary blood glucose (CBG) readings and insulin dose adjustment orders from the intensive therapy period into machine learning algorithms. Using a long short-term memory (LSTM) model, the system automatically extracted features and established memory patterns. Through iterative training and model optimization, the model was developed to predict the daily required insulin infusion doses (both basal rates and preprandial boluses) for any given blood glucose level.
- Masking
- None (open label)
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhimin Huang, Sun Yat-sen University
- Investigators
- Yanbing LI, MD.&Ph.D, Study chair, First Affiliated Hospital of Sun yat-sen U
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07066891
- Sponsor's protocol ID
- 2024836
- Other IDs
- 82070918
- Status last verified
- Oct 2026
- First submitted
- 7 Jun 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Liu L, Ke W, Li H, Li F, Fan G, Kuang J, Ma J, Zhang X, Ji B, Li S, Du Y, Xue Y, Lyu Z, Gao L, Qu S, Shi Y, Yan L, Deng W, Xu C, Dai P, Xu L, Liu J, Wan X, Wei G, Yu S, Hong S, Zhang P, Huang Z, Cao X, Liao Z, Xiao H, Mu Y, Handelsman Y, Li Y. Intense simplified strategy for newly diagnosed type 2 diabetes in patients with severe hyperglycaemia: multicentre, open label, randomised trial. BMJ. 2024 Oct 15;387:e080122. doi: 10.1136/bmj-2024-080122.
PubMed 39406449Chen A, Huang Z, Wan X, Deng W, Wu J, Li L, Cai Q, Xiao H, Li Y. Attitudes toward diabetes affect maintenance of drug-free remission in patients with newly diagnosed type 2 diabetes after short-term continuous subcutaneous insulin infusion treatment. Diabetes Care. 2012 Mar;35(3):474-81. doi: 10.2337/dc11-1638. Epub 2012 Jan 6.
PubMed 22228747Weng J, Li Y, Xu W, Shi L, Zhang Q, Zhu D, Hu Y, Zhou Z, Yan X, Tian H, Ran X, Luo Z, Xian J, Yan L, Li F, Zeng L, Chen Y, Yang L, Yan S, Liu J, Li M, Fu Z, Cheng H. Effect of intensive insulin therapy on beta-cell function and glycaemic control in patients with newly diagnosed type 2 diabetes: a multicentre randomised parallel-group trial. Lancet. 2008 May 24;371(9626):1753-60. doi: 10.1016/S0140-6736(08)60762-X.
PubMed 18502299Li Y, Xu W, Liao Z, Yao B, Chen X, Huang Z, Hu G, Weng J. Induction of long-term glycemic control in newly diagnosed type 2 diabetic patients is associated with improvement of beta-cell function. Diabetes Care. 2004 Nov;27(11):2597-602. doi: 10.2337/diacare.27.11.2597.
PubMed 15504992
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Insulin Dose Prediction Model Based on Long Short- Term Memory Artificial Intelligence Algorithm
- ClinicalTrials.gov ID
- NCT07066891
- Acronym / sponsor ID
- 2024836
- Conditions
- Diabetes Mellitus, Type 2 Diabetes
- Keywords
- long short-term memory, type 2 diabetes mellitus, continuous subcutaneous insulin infusion, intensive insulin therapy, insulin dose prediction model
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment was stopped early because hospital length-of-stay constraints limited protocol delivery. The PI's decision also took account of the available non-inferiority results.
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- 5 Dec 2025 (actual)
- Study completion
- 4 Feb 2026 (actual)
- First posted
- 15 Jul 2025 (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.
The present study aims to conduct a prospective controlled trial comparing an LSTM-based artificial intelligence (AI) prediction model and clinicians' experience in the efficacy and safety of blood glucose control in hospitalized patients with type 2 diabetes mellitus (T2DM) receiving continuous subcutaneous insulin infusion (CSII) treatment in the Department of Endocrinology. The main question it aims to answer is:
Is the prediction model superior to or (at least) non-inferior to clinicians' experience?
Eligible patients who receive CSII treatment are randomly allocated into the prediction model group and the empirical group. Patients will:
- Receive CSII treatment as standard of care during hospitalization for 1-2 weeks, where the daily insulin dose regimen is determined by a prediction model or a clinician's experience.
- Use continuous glucose monitoring (CGM) for glucose tracking.
- Receive diabetes self-management education covering nutrition and physical activity.
Detailed description
Data-driven artificial intelligence (AI) represents a new frontier in the modern medical field. The research group previously constructed a database included over 20 years clinical data of short-term intensive insulin therapy (SIIT) via continuous subcutaneous insulin infusion (CSII) in hospitalized patients with type 2 diabetes.The researchers had trained an insulin dose prediction model based on the database using long short-term memory (LSTM) AI algorithms. To establish more robust evidence to validate the efficacy and safety for this model, the present study aims to conduct a pilot prospective controlled trial comparing between AI prediction model and clinician's experience. Specifically, a randomized controlled trial is performed to compare the efficacy and safety of blood glucose control between the insulin dose prediction model and physicians' subjective experience in hospitalized patients with type 2 diabetes mellitus (T2DM) receiving CSII treatment in the Department of Endocrinology. A random number table of 400 participants will be generated using Excel, and randomly allocated into the prediction model group (n=200) and the empirical group (n=200). Medical data will be collected for all the enrolled patients, including medical history, physical examination, auxiliary test reports, continuous glucose monitoring (CGM) data, in which 8 points of the blood glucose (before and 2 hours- postprandial of the 3 main meals, bedtime, and 3 a.m. in the morning) are specifically collected to feed the model for prediction and used for comparisons. For the prediction model group, baseline information upon admission (including age, body mass index [BMI], weight, waist circumference, fasting blood glucose before admission and glycated hemoglobin) is put into the model, which will immediately return the insulin dosage (basal rate and boluses for each meal) for the first day of the insulin pump treatment. Physicians will then issue and execute these orders. On the following days, the model adjust the basal rate and boluses based on the previous day's glucose levels and insulin dosages. This process will continue iteratively during the whole CSII period (around 1 to 2 weeks based on whether or not the patient is newly diagnosed or with different disease durations). Insulin pump will be suspended after the administration of dinner bolus on the final day. Fasting blood glucose on the next day after insulin pump suspension will be recorded to conclude the study. In the control (emperical) group, physicians (residents under the guidance of attending doctors) determine insulin dosage based on individual clinical experience and daily glucose monitoring, with patient data collection identical to the prediction model group. Statistical analyses comparing between-group differences in glucose control during CSII treatment, such as time in range (TIR), time below range (TBR), mean blood glucose, glycemic variability, and post-therapy fasting glucose, insulin doses, etc to evaluate the efficacy and saftey of the two insulin dosage determination methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The insulin dose prediction model is constructed based on the database from the investigator's department, included all the type 2 diabetes mellitus (T2DM) patients who underwent short-term CSII therapy over the past 20 years. By combining patients' clinical characteristics, the investigators have input the daily capillary blood glucose (CBG) readings and insulin dose adjustment orders from the intensive therapy period into machine learning algorithms. Using a long short-term memory (LSTM) model, the system automatically extracted features and established memory patterns. Through iterative training and model optimization, the model was developed to predict the daily required insulin infusion doses (both basal rates and preprandial boluses) for any given blood glucose level.
| Arm | Type | Receives |
|---|---|---|
| Prediction model group | Experimental | Drug: CSII in the prediction model groupFor the prediction model group, baseline information upon admission (including age, gender, body mass index [BMI], weight, waist circumference, fasting blood glucose before admission, glycated hemoglobin) will be put into the model, which will immediately return the insulin dosage for the first day of insulin pump treatment (basal rate and boluses of each meal). Physicians will then issue and execute these orders. On the following days, the model will adjust the basal rate and the boluses based on the blood glucose level on the previous day and the insulin dosages. This process continue iteratively for the whole CSII treatment period (about 1 to 2 weeks based on whether or not the patient is newly diagnosed or with different disease duration). The insulin pump is suspended after the administration of dinner bolus on the final day. Fasting blood glucose on the next day after insulin pump suspension will be recorded to conclude the study. |
| Empirical group | Active comparator | Drug: CSII in the empirical groupDuring the CSII treatment, clinicians (mainly residents under the guidance of attending doctors) determine the everyday insulin dosages based on clinical experience and daily glucose monitoring, with patient data collection identical to the experimental group. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Meets the diagnostic criteria of type 2 diabetes mellitus in the Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes (2020 edition).
- Insulin pump is used to control blood glucose during hospitalization, and the duration of CSII treatment period ≥6 days and <30 days.
Key exclusion criteria (6 listed)
- Diabetes other than type 2.
- Age ≥75 years who is not suitable for intensive insulin therapy.
- Hypoglycemic regimen other than CSII treatment, such as oral hypoglycemic drugs or multiple daily insulin injections during hospitalization.
- With severe infection or uncontrolled acute complications (including ketoacidosis coma, hyperosmolar hyperglycemia, etc.) , or any condition that the researcher believes not suitable for the study.
- Severe hepatic and renal insufficiency (ALT≥5 times the upper limit of normal, eGFR<30ml/min/1.73m2) ), or patients at the acute stage of cardiovascular and cerebrovascular diseases considered unsuitable for study.
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 |
|---|---|---|
| CSII in the prediction model group1. Everyday insulin dosage decided by AI prediction model. 2. CSII treatment continues for 1 to 2 weeks based on whehter or not the patient is newly diagnosed or with different disease duration. | Drug | Prediction model group |
| CSII in the empirical group1. Everyday insulin dosage decided by clinicans' experience. 2. CSII treatment continues for 1 to 2 weeks based on whether or not the patient is newly diagnosed or with different disease duration. | Drug | Empirical group |
Primary outcome
Time in range
Time frame: During continuous subcutaneous insulin infusion treatment period（assessed up to 2 weeks, the treatment period between the initiation and suspension of the insulin pump)
Time in range refers to the percentage time in range between 3.9mmol/L and 10.0 mmol/L in continuous glucose monitoring data during the continuous subcutaneous insulin infusion treatment period.
Time below range
Time frame: During continuous subcutaneous insulin infusion treatment period（assessed up to 2 weeks, the treatment period between the initiation and suspension of the insulin pump)
Time below range refers to percentage time of glucose<3.9mmol/L in continuous glucose monitoring data during the continuous subcutaneous insulin infusion treatment period.
2 secondary outcomes
Post-therapy fasting blood glucose
Time frame: 12 hours after insulin pump suspension.
HbA1c at 3 months after discharge
Time frame: 3 months after discharge.
Results and safety
The study was stopped early (reason given: Recruitment was stopped early because hospital length-of-stay constraints limited protocol delivery. The PI's decision also took account of the available non-inferiority results.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Background: PubMed 39406449Liu L, Ke W, Li H, Li F, Fan G, Kuang J, Ma J, Zhang X, Ji B, Li S, Du Y, Xue Y, Lyu Z, Gao L, Qu S, Shi Y, Yan L, Deng W, Xu C, Dai P, Xu L, Liu J, Wan X, Wei G, Yu S, Hong S, Zhang P, Huang Z, Cao X, Liao Z, Xiao H, Mu Y, Handelsman Y, Li Y. Intense simplified strategy for newly diagnosed type 2 diabetes in patients with severe hyperglycaemia: multicentre, open label, randomised trial. BMJ. 2024 Oct 15;387:e080122. doi: 10.1136/bmj-2024-080122.
- Background: PubMed 22228747Chen A, Huang Z, Wan X, Deng W, Wu J, Li L, Cai Q, Xiao H, Li Y. Attitudes toward diabetes affect maintenance of drug-free remission in patients with newly diagnosed type 2 diabetes after short-term continuous subcutaneous insulin infusion treatment. Diabetes Care. 2012 Mar;35(3):474-81. doi: 10.2337/dc11-1638. Epub 2012 Jan 6.
- Background: PubMed 18502299Weng J, Li Y, Xu W, Shi L, Zhang Q, Zhu D, Hu Y, Zhou Z, Yan X, Tian H, Ran X, Luo Z, Xian J, Yan L, Li F, Zeng L, Chen Y, Yang L, Yan S, Liu J, Li M, Fu Z, Cheng H. Effect of intensive insulin therapy on beta-cell function and glycaemic control in patients with newly diagnosed type 2 diabetes: a multicentre randomised parallel-group trial. Lancet. 2008 May 24;371(9626):1753-60. doi: 10.1016/S0140-6736(08)60762-X.
- Background: PubMed 15504992Li Y, Xu W, Liao Z, Yao B, Chen X, Huang Z, Hu G, Weng J. Induction of long-term glycemic control in newly diagnosed type 2 diabetic patients is associated with improvement of beta-cell function. Diabetes Care. 2004 Nov;27(11):2597-602. doi: 10.2337/diacare.27.11.2597.
- Individual participant dataSharing planned: Undecided
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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.
Yanbing LI, MD.&Ph.D study chair
First Affiliated Hospital of Sun yat-sen U
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CSII in the prediction model group and CSII in the empirical group in people with Diabetes Mellitus and Type 2 Diabetes, run by Sun Yat-sen University 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 2 inclusion and 6 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: stopped early, as of the sponsor's last update on 20 Oct 2026. 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?
The study was stopped early (reason given: Recruitment was stopped early because hospital length-of-stay constraints limited protocol delivery. The PI's decision also took account of the available non-inferiority results.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in range (time frame: During continuous subcutaneous insulin infusion treatment period（assessed up to 2 weeks, the treatment period between the initiation and suspension of the insulin pump)). The study lists 2 primary outcomes in all. 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 NCT07066891, which also lists 4 linked publications.
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 20 Oct 2026.