Validation of Insulin Dose Prediction Model Based on Artificial Intelligence Algorithm

NCT ID: NCT07066891

Last Updated: 2025-08-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-15
• Study Completion Date: 2026-06-30

Brief 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 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:

1. 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.

2. Use continuous glucose monitoring (CGM) for glucose tracking.

3. 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.

Conditions

Diabetes Mellitus; Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Prediction model group

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.

Group Type: EXPERIMENTAL

CSII in the prediction model group

Intervention Type: DRUG

1. 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.

Empirical group

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.

Group Type: ACTIVE_COMPARATOR

CSII in the empirical group

Intervention Type: DRUG

1. 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.

Interventions

CSII in the prediction model group

1. 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.

Intervention Type: DRUG

CSII in the empirical group

1. 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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Meets the diagnostic criteria of type 2 diabetes mellitus in the Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes (2020 edition).

2. Insulin pump is used to control blood glucose during hospitalization, and the duration of CSII treatment period ≥6 days and <30 days.

Exclusion Criteria

1. Diabetes other than type 2.

2. Age ≥75 years who is not suitable for intensive insulin therapy.

3. Hypoglycemic regimen other than CSII treatment, such as oral hypoglycemic drugs or multiple daily insulin injections during hospitalization.

4. 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.

5. 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.

6. Pregnancy.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Zhimin Huang

Professor, Department of Endocrinology and Diabetes Center, the First Affiliated Hospital of Sun Yat-sen University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yanbing LI, MD.&Ph.D

Role: STUDY_CHAIR

First Affiliated Hospital of Sun yat-sen U

Locations

Department of Endocrinology and Diabetes Center, The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhimin Huang, MD. & PhD.

Role: CONTACT

hzhim@mail.sysu.edu.cn

+86 13925057613

Yuping Cao, B.S.

Role: CONTACT

caoyp5@mail2.sysu.edu.cn

+86 15107688525

Facility Contacts

Zhimin Huang, MD. & PhD.

Role: primary

hzhim@mail.sysu.edu.cn

+86 13925057613

References

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.

Reference Type: BACKGROUND

PMID: 39406449 (View on PubMed)

Chen 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.

Reference Type: BACKGROUND

PMID: 22228747 (View on PubMed)

Weng 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.

Reference Type: BACKGROUND

PMID: 18502299 (View on PubMed)

Li 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.

Reference Type: BACKGROUND

PMID: 15504992 (View on PubMed)

Other Identifiers

82070918

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2024836

Identifier Type: -

Identifier Source: org_study_id