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Type 1 Diabetes MellitusNCT07732777

AI-Assisted Remote Insulin Pump Optimization in T1DM

A study testing AI-Assisted Insulin Pump Settings Optimization System and Conventional Insulin Pump Therapy in people with Type 1 Diabetes Mellitus and Type 1 Diabetes (T1D), run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 14 to 65 years
What is being tested?
AI-Assisted Insulin Pump Settings Optimization System and Conventional Insulin Pump Therapy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteChina
Study dates
28 Jan 2026to 31 Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jing Lu, PhD contact

0086-025-83106666-61431

lujingsnow@126.com

China1 site, 1 recruiting

  • Department of Endocrinology

    Nanjing, Jiangsu, 210008

    Jing Lu, PhD, 0086-025-83106666-61431, lujingsnow@126.com

    Yan Bi, PhD

    Recruiting

Other trials in China

About this study

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

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.

Read the 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.

Being tested
AI-Assisted Insulin Pump Settings Optimization System, Conventional Insulin Pump Therapy
Keywords
Type 1 Diabetes, Insulin Pump, Continuous Glucose Monitoring, Artificial Intelligence, Insulin Dosage Adjustment
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AI-Assisted Insulin Pump Settings Optimization SystemDevice

    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.

  • Conventional Insulin Pump TherapyDevice

    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.

Study groups in NCT07732777
Study groupRoleWhat they receive
Inpatient AI OptimizationExperimentalDuring 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.
Receives: Device: AI-Assisted Insulin Pump Settings Optimization System
Home AI-First (Sequence A)ExperimentalParticipants 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.
Receives: Device: AI-Assisted Insulin Pump Settings Optimization System
Home Control-First (Sequence B)ExperimentalParticipants 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.
Receives: Device: Conventional Insulin Pump Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time-in-Range (TIR)

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

    Measured: the last 2 weeks of each 4-week intervention period

Secondary outcomes (13)

  1. Percentage of Time with Glucose Below 3.9 mmol/L

    Percentage of CGM readings below 3.9 mmol/L during each 4-week crossover period.

    Measured: the last 2 weeks of each 4-week intervention period

  2. Percentage of Time with Glucose Above 10.0 mmol/L

    Percentage of CGM readings above 10.0 mmol/L during each 4-week crossover period.

    Measured: the last 2 weeks of each 4-week intervention period

  3. Mean Sensor Glucose

    Mean CGM glucose level (mmol/L) during each 4-week crossover period.

    Measured: the last 2 weeks of each 4-week intervention period

  4. Glycemic Variability

    coefficient of variation (%CV) of CGM glucose levels during each 4-week crossover period.

    Measured: the last 2 weeks of each 4-week intervention period

  5. Total Daily Insulin Dose

    Mean total daily insulin dose (units/day) during each 4-week crossover period.

    Measured: the last 2 weeks of each 4-week intervention period

  6. Incidence of Diabetic Ketoacidosis (DKA)

    Number of DKA events occurring during the study.

    Measured: through study completion, an average of 12 weeks

  7. Incidence of Severe Hypoglycemic Events

    Number of severe hypoglycemic events (requiring assistance of another person) during the study.

    Measured: through study completion, an average of 12 weeks

  8. Incidence of Adverse Events and Serious Adverse Events

    Incidence of all AEs and SAEs, including relationship to study device and severity.

    Measured: through study completion, an average of 12 weeks

  9. Physician Acceptance Rate

    Proportion of algorithm-generated recommendations accepted by the physician

    Measured: through the 4-week AI-Assisted Systme intervention

  10. Physician Satisfaction with AI-Assisted System

    Mean scores from a modified clinician satisfaction survey evaluating usability, reliability, and overall experience.

    Measured: the end of the 4-week AI-Assisted Systme intervention

  11. Patient Treatment Satisfaction

    Mean scores from the Diabetes Treatment Satisfaction Questionnaire (DTSQ)

    Measured: the end of each 4-week intervention period

  12. Percentage of Time with Glucose Above 13.9 mmol/L

    Percentage of CGM readings above 13.9 mmol/L during each 4-week crossover period.

    Measured: the last 2 weeks of each 4-week intervention period

  13. Percentage of Time with Glucose Below 3.0 mmol/L

    Percentage of CGM readings below 3.0 mmol/L during each 4-week crossover period.

    Measured: the last 2 weeks of each 4-week intervention period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2026
  2. Study start28 Jan 2026
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
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.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07732777
Sponsor's protocol ID
2025-1221-01
Status last verified
Jun 2026
First submitted
21 Jun 2026
Last updated
29 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing AI-Assisted Insulin Pump Settings Optimization System and Conventional Insulin Pump Therapy in people with Type 1 Diabetes Mellitus and Type 1 Diabetes (T1D), run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jing Lu, PhD (0086-025-83106666-61431, lujingsnow@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time-in-Range (TIR) (time frame: the last 2 weeks of each 4-week intervention period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07732777.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026; AzTrials last refreshed its copy on 29 Oct 2026.

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