Validation of Insulin Dose Prediction Model Based on Artificial Intelligence Algorithm

Sun Yat-sen University

Status: Enrolling

Conditions: Diabetes Mellitus; Type 2 Diabetes

Treatments: Drug: CSII in the prediction model group; Drug: CSII in the empirical group

Study type: Interventional

Funder types: Other

Identifiers

NCT07066891

82070918 (Other Grant/Funding Number)

2024836

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Prediction model group

Experimental group

Description:

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.

Treatment:

Drug: CSII in the prediction model group

Empirical group

Active Comparator group

Description:

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.

Treatment:

Drug: CSII in the empirical group