AI-Assisted Remote Insulin Pump Optimization in T1DM

NCT07732777 | Recruiting DMC

• 1 other identifier: 2025-1221-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 1 Diabetes Mellitus; Type 1 Diabetes (T1D)

Keywords

Type 1 Diabetes; Insulin Pump; Continuous Glucose Monitoring; Artificial Intelligence; Insulin Dosage Adjustment

Outcome Measures

Primary Outcomes (1)

• Time-in-Range (TIR)

  Percentage of glucose readings within range of 3.9 to 10 mmol/l

  the last 2 weeks of each 4-week intervention period

Secondary Outcomes (13)

• Percentage of Time with Glucose Below 3.9 mmol/L

  the last 2 weeks of each 4-week intervention period

• Percentage of Time with Glucose Above 10.0 mmol/L

  the last 2 weeks of each 4-week intervention period

• Mean Sensor Glucose

  the last 2 weeks of each 4-week intervention period

• Glycemic Variability

  the last 2 weeks of each 4-week intervention period

• Total Daily Insulin Dose

  the last 2 weeks of each 4-week intervention period

Study Arms (3)

Inpatient AI Optimization

EXPERIMENTAL

During the inpatient stay, the AI-assisted decision support system will analyze continuous glucose monitoring and insulin pump data to generate daily recommendations for optimizing insulin dosage. All algorithm-generated recommendations will be reviewed and approved by physicians before implementation.

Device: AI-Assisted Insulin Pump Settings Optimization System

Home AI-First (Sequence A)

EXPERIMENTAL

Participants in this arm will complete a home-based crossover trial. In the first 4-week period, they will receive AI-assisted remote optimization of insulin pump settings. The AI algorithm will analyze weekly uploaded CGM and insulin data to generate parameter adjustment recommendations, which will be reviewed and approved by a physician prior to remote transmission to the participant's mobile app. In the second 4-week period, they will switch to conventional pump therapy without AI-assisted recommendations.

Device: AI-Assisted Insulin Pump Settings Optimization System

Home Control-First (Sequence B)

EXPERIMENTAL

Participants in this arm will complete a home-based crossover trial. In the first 4-week period, they will receive conventional pump therapy without AI-assisted recommendations In the second 4-week period, they will cross over to receive AI-assisted remote optimization of insulin pump settings. The AI algorithm will analyze weekly uploaded CGM and insulin data to generate parameter adjustment recommendations, which will be reviewed and approved by a physician prior to remote transmission to the participant's mobile app.

Device: Conventional Insulin Pump Therapy

Interventions

AI-Assisted Insulin Pump Settings Optimization System DEVICE

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.

Home AI-First (Sequence A); Inpatient AI Optimization

Conventional Insulin Pump Therapy DEVICE

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.

Home Control-First (Sequence B)

Eligibility Criteria

• Age: 14 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

Study Sites (1)

Department of Endocrinology

Nanjing, Jiangsu, 210008, China

RECRUITING

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

Central Study Contacts

Jing Lu, PhD

CONTACT

0086-025-83106666-61431; lujingsnow@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician, Department of Endocrinology

Model Details: This study consists of two independent parallel cohorts: Cohort 1 (inpatient) is a single-arm safety feasibility study; Cohort 2 (home-based) is a two-period randomized crossover trial. The crossover model applies to Cohort 2, which constitutes the primary efficacy analysis.

Study Record Dates

• First Submitted: June 21, 2026
• First Posted: July 29, 2026
• Study Start: January 28, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 29, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)