Efficacy and Safety of an Artificial-pancreas-like Learning-based Control in Type 1 Diabetes on Multiple Daily Injection Therapy

NCT06418464 | Not Yet Recruiting

• 1 other identifier: 2023YFE0204100
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is designed as a blinded, multi-center, non-inferiority randomized controlled clinical trial. It aims to enroll hospitalized T1D diabetes patients, ensuring an equal distribution with a 1:1 ratio between the intervention and control groups. The trial is set to take place across three locations in China: Peking University People's Hospital, Hebei Provincial People's Hospital, and Xingtai People's Hospital. Before participating, all subjects are required to provide their consent by signing a written informed consent form. Within the framework of the trial, the intervention group will receive insulin dosage recommendations from AP-A, subject to approval by a physician, whereas the control group will be treated with insulin dosages according to the current clinical guidelines established by their physicians.

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

• Time in Range (TIR)

  The proportion of time that the glucose levels, as recorded by CGM during the treatment period, are within the range of 3.9mmol/L to 10.0mmol/L. This metric can be directly obtained by the algorithm system through closed-loop reading of CGM data.

  At the end of the treatment period

Secondary Outcomes (12)

• Time Below Range (TBR)

  At the end of the treatment period

• Other Secondary Outcomes1

  At the end of the treatment period

• Other Secondary Outcomes2

  At the end of the treatment period

• Other Secondary Outcomes3

  At the end of the treatment period

• Other Secondary Outcomes4

  At the end of the treatment period

Study Arms (2)

AP-A Dosage Decision Support System

EXPERIMENTAL

The AP-A Dosage Decision Support System represents a new solution in diabetes care, offering customized insulin dosage recommendations to patients. This system is a product of integrating four pivotal modules: the individualized model learning module, the risk-sensitive control module, the Bayesian optimization module, and the safety constraint module. Together, they establish a robust framework that employs advanced computational methodologies to deliver precise and personalized insulin dosage guidance, significantly improving the effectiveness and safety of diabetes treatment plans. The actual injection dose in the intervention group was executed by the doctor after approval based on the recommendation of the AP-A Dosage Decision Support System.

Device: AP-A Dosage Decision Support System

Physician decision-making

ACTIVE COMPARATOR

The injection dose of the control group was determined by the doctor solely.

Device: AP-A Dosage Decision Support System

Interventions

AP-A Dosage Decision Support System DEVICE

The AP-A Dosage Decision Support System represents a new solution in diabetes care, offering customized insulin dosage recommendations to patients. This system is a product of integrating four pivotal modules: the individualized model learning module, the risk-sensitive control module, the Bayesian optimization module, and the safety constraint module. Together, they establish a robust framework that employs advanced computational methodologies to deliver precise and personalized insulin dosage guidance, significantly improving the effectiveness and safety of diabetes treatment plans. The actual injection dose in the intervention group was executed by the doctor after approval based on the recommendation of the AP-A Dosage Decision Support System.

AP-A Dosage Decision Support System; Physician decision-making

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntary signing of an informed consent form.
• Age between 18 and 70 years, with a T1D diagnosis of at least one year.
• A confirmed diagnosis of T1D diabetes by at least two endocrinologists and fulfillment of at least one of the following conditions: a) Fasting C-peptide level less than 0.3 ng/mL. b) Fasting C-peptide level between 0.3 ng/mL and 0.6 ng/mL with at least one positive diabetic autoantibody.
• Receiving intensified treatment regimen with multiple daily subcutaneous insulin injections upon screening and during the whole study period.

You may not qualify if:

• Conditions such as diabetic ketoacidosis, diabetic ketosis, hyperglycemic hyperosmolar state, or other acute complications related to diabetes.
• The presence of concurrent fever, severe infections, acute abdominal conditions, uncontrolled thyroid dysfunction, or the acute phase of any organ system disease.
• A history within the last 3 months of serious cardiovascular issues including decompensated heart failure (NYHA Class III or IV), myocardial infarction, coronary artery bypass grafting, or coronary stent implantation, as well as uncontrolled severe arrhythmias or ischemic or hemorrhagic stroke.
• Laboratory test abnormalities that exceed certain thresholds, such as alanine transaminase or aspartate transaminase levels greater than three times the upper limit of normal, total bilirubin levels more than twice the upper limit of normal, hemoglobin levels below 100 g/L, albumin levels below 30 g/L, or an estimated glomerular filtration rate (eGFR) less than 60 ml/min/1.73m².
• Individuals who are required to fast or are unable to eat normally due to special circumstances.
• Pregnant or breastfeeding women.
• Individuals suffering from psychiatric illnesses or other cognitive impairments that may affect their ability to participate in the study.
• Participants who are unable to wear a CGM due to severe allergies, skin diseases, or conditions at the sensor site such as lesions, scarring, redness, infection, or edema, which could interfere with the sensor's adhesion or the accuracy of glucose measurements in the interstitial fluid.
• The systemic use of corticosteroids within the last month, with the exception of inhaled or topical steroids.

Sponsors & Collaborators

• Peking University People's Hospital: lead
• Hebei Provincial People's Hospital: collaborator
• Xingtai People's Hospital: collaborator

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 13, 2024
• First Posted: May 17, 2024
• Study Start: July 1, 2024
• Primary Completion: March 30, 2025
• Study Completion: June 30, 2025
• Last Updated: May 17, 2024

Record last verified: 2024-05