AI-Assisted Remote Insulin Pump Optimization in T1DM

Официальное название

Evaluating AI-Assisted Remote Optimization of Insulin Pump Settings in Type 1 Diabetes Using CGM

Обзор

This study evaluates an AI-assisted remote parameter optimization tool for individuals with type 1 diabetes （T1D） using insulin pump and continuous glucose monitoring (CGM). The Artificial Intelligence (AI) algorithm analyzes regularly CGM and insulin data to generate personalized recommendations for adjusting pump settings. All algorithm-generated recommendations are reviewed and approved by physicians before being transmitted to the participant's mobile application for implementation.

Подробное описание

This study consists of two independent, parallel cohorts. Participants are assigned to only one of the two cohorts and do not crossover between cohorts.

Cohort 1 (Inpatient Phase): A separate group of hospitalized adults with T1D will undergo AI-assisted insulin pump parameter optimization over 5-7 days under close clinical supervision. This cohort is designed to evaluate the short-term safety, feasibility, and glycemic responses to the AI algorithm in a controlled inpatient setting.

Cohort 2 (Home-based Phase): A separate group of outpatients with T1D will be randomized in a 1:1 ratio to a two-period crossover design over 11 weeks. This cohort evaluates the efficacy and safety of AI-assisted remote parameter optimization compared to conventional therapy in the home environment.

Вмешательства

• Устройство AI-Assisted Insulin Pump Settings Optimization System
  A cloud-based software system that analyzes continuous glucose monitoring and insulin pump data to generate recommendations for optimizing insulin pump settings. All recommendations are reviewed and approved by a physician prior to implementation.
• Устройство Conventional Insulin Pump Therapy
  Sensor-augmented insulin pump therapy using continuous glucose monitoring with dose adjustments made by the participant and/or physician per standard clinical practice, without AI-assisted algorithmic recommendations.

Первичные конечные точки

• Time-in-Range (TIR) [Срок оценки: the last 2 weeks of each 4-week intervention period]

Вторичные конечные точки (12)

• Percentage of Time with Glucose Below 3.9 mmol/L [Срок оценки: the last 2 weeks of each 4-week intervention period]
• Percentage of Time with Glucose Above 10.0 mmol/L [Срок оценки: the last 2 weeks of each 4-week intervention period]
• Mean Sensor Glucose [Срок оценки: the last 2 weeks of each 4-week intervention period]
• Glycemic Variability [Срок оценки: the last 2 weeks of each 4-week intervention period]
• Total Daily Insulin Dose [Срок оценки: the last 2 weeks of each 4-week intervention period]
• Incidence of Diabetic Ketoacidosis (DKA) [Срок оценки: through study completion, an average of 12 weeks]
• Incidence of Severe Hypoglycemic Events [Срок оценки: through study completion, an average of 12 weeks]
• Incidence of Adverse Events and Serious Adverse Events [Срок оценки: through study completion, an average of 12 weeks]
• Physician Acceptance Rate [Срок оценки: through the 4-week AI-Assisted Systme intervention]
• Physician Satisfaction with AI-Assisted System [Срок оценки: the end of the 4-week AI-Assisted Systme intervention]
• Patient Treatment Satisfaction [Срок оценки: the end of each 4-week intervention period]
• Percentage of Time with Glucose Above 13.9 mmol/L [Срок оценки: the last 2 weeks of each 4-week intervention period]

Критерии участия

Критерии включения

• Clinical diagnosis of T1D, meeting all three of the following criteria:

• Clinical medical records or a certification document issued by a specialist physician confirming the diagnosis;
• At least one of the following: age at disease onset < 15 years; presentation with ketosis or diabetic ketoacidosis (DKA) at onset; no overweight or obesity at onset; highest random C-peptide < 200 pmol/L;
• At least one of the following: continuous insulin therapy initiated after diagnosis; positive for any islet autoantibody.
• Age 14 to 65 years, inclusive, male or female.
• HbA1c < 11.0% at the screening visit.
• At least 3 months of documented T1D duration, and at least 3 months of treatment with either multiple daily insulin injections (MDI) or insulin pump therapy.
• Willing to wear the study device continuously throughout the trial and to use either insulin aspart or insulin lispro.
• Willing to perform at least one fingerstick blood glucose measurement per day.
• Willing to upload data from the study device.
• Willing and able to provide signed informed consent (by the participant and/or legally authorized representative) and to learn basic diabetes management and study device operation.

Критерии исключения

• History of severe hypoglycemia within the 6 months prior to screening, defined as an event requiring medical assistance (i.e., physician office visit, emergency room visit, or hospitalization), coma, seizure, or hypoglycemia with loss of consciousness.
• Unresolved acute complications of diabetes at screening, including diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic state (HHS), or hyperglycemia with severe circulatory impairment.
• Unresolved adverse skin conditions at the intended device placement site (e.g., psoriasis, dermatitis herpetiformis, rash, staphylococcal infection) at screening.
• Intolerance to subcutaneous infusion sets or adhesive tapes, or presence of edema.
• Presence of significant acute or chronic complications, hepatorenal disease, or other systemic diseases at screening. Hyperthyroidism or hypothyroidism with unstable thyroid function at the time of screening, defined as thyroid-stimulating hormone outside the normal range with concurrent abnormal free triiodothyronine or free thyroxine levels.
• Prior pancreas or islet cell transplantation.
• Any of the following cardiovascular or cerebrovascular events within 1 year prior to screening: myocardial infarction, heart failure (NYHA Class III/IV), unstable angina, coronary artery bypass grafting, coronary stent implantation, angina pectoris, congestive heart failure, ventricular arrhythmia, transient ischemic attack (TIA), cerebrovascular accident (CVA), or other thromboembolic disease.
• Diagnosis of any of the following: malignancy, tuberculosis or other chronic wasting disease, hematological disorder, psychiatric disorder, systemic lupus erythematosus, rheumatoid arthritis, autoimmune hemolytic anemia, or clinically significant malabsorption. Diagnosis of adrenal insufficiency, or current treatment for hyperthyroidism, or planned treatment for hyperthyroidism during the study period.
• History of drug abuse or alcohol abuse.
• Use of any oral, injectable, or intravenous glucocorticoids within 8 weeks prior to screening, or planned use during the study period.
• Use of any of the following non-insulin glucose-lowering agents within 8 weeks prior to screening, or planned use during the study period: thiazolidinediones (TZDs), alpha-glucosidase inhibitors, sulfonylureas (SUs), glinides, dipeptidyl peptidase-4 inhibitors (DPP-4i), sodium-glucose cotransporter-2 inhibitors (SGLT2i), or glucagon-like peptide-1 receptor agonists (GLP-1 RAs). Participants currently using any of these agents must undergo a washout period of at least 7 days prior to enrollment.
• Planned elective surgery requiring general anesthesia, or planned dialysis during the study period.
• For women of childbearing potential: pregnancy, lactation, positive pregnancy test at screening, or planned pregnancy during the study period. Women of childbearing potential who are not using an effective method of contraception (e.g., oral contraceptives, intrauterine device, barrier method with spermicide, or surgical sterilization) and who do not agree to continue using such effective contraception during the study period will be excluded.
• Current participation in, or treatment with an investigational drug or device within 2 weeks prior to screening (observational studies are permitted).
• Any other condition that, in the investigator's judgment, would make the participant unsuitable for the study, including but not limited to: history of ocular trauma or other confirmed ocular disease causing blurred vision, deafness, eating disorders, celiac disease, or being underweight (Body Mass Index < 18 kg/m²).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Department of Endocrinology — Нанкин

Идентификаторы

NCT: NCT07732777 · 2025-1221-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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