Type 1 Diabetes Mellitus, Type 1 Diabetes (T1D)
Conditions
Keywords
Type 1 Diabetes, Insulin Pump, Continuous Glucose Monitoring, Artificial Intelligence, Insulin Dosage Adjustment
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.
Detailed description
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.
Interventions
DEVICEAI-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.
DEVICEConventional 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.
Sponsors
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
14 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Clinical diagnosis of T1D, meeting all three of the following criteria: 1. Clinical medical records or a certification document issued by a specialist physician confirming the diagnosis; 2. 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; 3. At least one of the following: continuous insulin therapy initiated after diagnosis; positive for any islet autoantibody. 2. Age 14 to 65 years, inclusive, male or female. 3. HbA1c \< 11.0% at the screening visit. 4. 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. 5. Willing to wear the study device continuously throughout the trial and to use either insulin aspart or insulin lispro. 6. Willing to perform at least one fingerstick blood glucose measurement per day. 7. Willing to upload data from the study device. 8. 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.
Exclusion criteria
1. 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. 2. Unresolved acute complications of diabetes at screening, including diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic state (HHS), or hyperglycemia with severe circulatory impairment. 3. Unresolved adverse skin conditions at the intended device placement site (e.g., psoriasis, dermatitis herpetiformis, rash, staphylococcal infection) at screening. 4. Intolerance to subcutaneous infusion sets or adhesive tapes, or presence of edema. 5. 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. 6. Prior pancreas or islet cell transplantation. 7. 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. 8. 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. 9. History of drug abuse or alcohol abuse. 10. Use of any oral, injectable, or intravenous glucocorticoids within 8 weeks prior to screening, or planned use during the study period. 11. 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. 12. Planned elective surgery requiring general anesthesia, or planned dialysis during the study period. 13. 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. 14. Current participation in, or treatment with an investigational drug or device within 2 weeks prior to screening (observational studies are permitted). 15. 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time-in-Range (TIR) | the last 2 weeks of each 4-week intervention period | Percentage of glucose readings within range of 3.9 to 10 mmol/l |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Time with Glucose Below 3.9 mmol/L | the last 2 weeks of each 4-week intervention period | Percentage of CGM readings below 3.9 mmol/L during each 4-week crossover period. |
| Percentage of Time with Glucose Above 10.0 mmol/L | the last 2 weeks of each 4-week intervention period | Percentage of CGM readings above 10.0 mmol/L during each 4-week crossover period. |
| Mean Sensor Glucose | the last 2 weeks of each 4-week intervention period | Mean CGM glucose level (mmol/L) during each 4-week crossover period. |
| Glycemic Variability | the last 2 weeks of each 4-week intervention period | coefficient of variation (%CV) of CGM glucose levels during each 4-week crossover period. |
| Total Daily Insulin Dose | the last 2 weeks of each 4-week intervention period | Mean total daily insulin dose (units/day) during each 4-week crossover period. |
| Incidence of Diabetic Ketoacidosis (DKA) | through study completion, an average of 12 weeks | Number of DKA events occurring during the study. |
| Incidence of Severe Hypoglycemic Events | through study completion, an average of 12 weeks | Number of severe hypoglycemic events (requiring assistance of another person) during the study. |
| Incidence of Adverse Events and Serious Adverse Events | through study completion, an average of 12 weeks | Incidence of all AEs and SAEs, including relationship to study device and severity. |
| Physician Acceptance Rate | through the 4-week AI-Assisted Systme intervention | Proportion of algorithm-generated recommendations accepted by the physician |
| Physician Satisfaction with AI-Assisted System | the end of the 4-week AI-Assisted Systme intervention | Mean scores from a modified clinician satisfaction survey evaluating usability, reliability, and overall experience. |
| Patient Treatment Satisfaction | the end of each 4-week intervention period | Mean scores from the Diabetes Treatment Satisfaction Questionnaire (DTSQ) |
| Percentage of Time with Glucose Above 13.9 mmol/L | the last 2 weeks of each 4-week intervention period | Percentage of CGM readings above 13.9 mmol/L during each 4-week crossover period. |
| Percentage of Time with Glucose Below 3.0 mmol/L | the last 2 weeks of each 4-week intervention period | Percentage of CGM readings below 3.0 mmol/L during each 4-week crossover period. |
Countries
China
Contacts
CONTACTJing Lu, PhD
Outcome results
None listed