Validation of Insulin Dose Prediction Model Based on Long Short- Term Memory Artificial Intelligence Algorithm

Status: Recruiting

Location: See location...

Intervention Type: Drug

Study Type: Interventional

Study Phase: Not Applicable

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.

Eligibility

Participation Requirements

Sex: All

Minimum Age: 18

Maximum Age: 75

Healthy Volunteers: f

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• 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.

Locations

Other Locations

China

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

RECRUITING

Guangzhou

Contact Information

Primary

Zhimin Huang, MD. & PhD.

hzhim@mail.sysu.edu.cn

+86 13925057613

Backup

Yuping Cao, B.S.

caoyp5@mail2.sysu.edu.cn

+86 15107688525

Time Frame

Start Date: 2025-07-15

Estimated Completion Date: 2026-06

Participants

Target number of participants: 400

Treatments

Experimental: 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.

Active_comparator: 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.

Related Therapeutic Areas

Type 2 Diabetes (T2D)

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Validation of Insulin Dose Prediction Model Based on Long Short- Term Memory Artificial Intelligence Algorithm

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