type 1 diabetes
Conditions
Interventions
Closed-Loop group:Closed-Loop Insulin Infusion System (Model SY-201, Medtrum Technologies Inc.)
Non-closed-Loop group:Insulin Pump (Medtronic MiniMed 712)
Sponsors
Children's Hospital of Fudan University
Eligibility
Sex/Gender
All
Age
5 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1. Male or female, aged 5 to 18 years ( 7.3; HCO3? > 18 mmol/L. 5. The subject and their legally authorized guardian agree to participate and sign the informed consent form;
Exclusion criteria
Exclusion criteria: 1. Presence of uncorrected acute diabetic complications at screening, such as diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic state (HHS); 2. Hyperthyroidism, primary hypothyroidism, or central hypothyroidism (excluding transient thyroid dysfunction attributed by the investigator to diabetic ketoacidosis); 3. Coagulation tests showing APTT (activated partial thromboplastin time) or PT (prothrombin time) >1.5× the upper limit of normal (ULN), or other severe bleeding conditions that would affect venous blood sampling; 4. Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m². 5. Adverse skin conditions (e.g., diffuse subcutaneous nodules, psoriasis, scars, etc.) at the intended insertion sites for the glucose sensor or insulin pump infusion set. 6. Known current vision and/or hearing impairment in the subject and/or guardian that, in the investigator’s judgment, would directly affect the subject’s ability to participate in this trial and safely perform all trial procedures. 7. Occurrence of any of the following cardiovascular events within 8 weeks prior to screening: a) Decompensated heart failure (New York Heart Association [NYHA] Class III or IV); b) Unstable angina; c) History of myocardial infarction, coronary artery bypass grafting (CABG), or coronary stent implantation; d) Uncontrolled or severe arrhythmia. 8. Use of immunosuppressants or systemic corticosteroids (excluding topical or inhaled preparations) for more than 7 days within 3 months prior to screening. 9. Anticipation of major surgery during the trial that would directly affect insulin pump therapy. 10. Guardian and/or subjects aged 8 years and older who lack self-control or are unable to express themselves clearly. 11. Any other severe disease that, in the investigator’s judgment, may interfere with the trial results, such as malignancy. 12. Participation in another clinical trial within 1 month prior to screening. 13. Any other condition deemed by the investigator as unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The average time (TIR) of blood glucose within the target range on days 7, 8, and 9The average time (TIR) of blood glucose within the target range on days 7, 8, and 9; | — |
Secondary
| Measure | Time frame |
|---|---|
| Side effect;Changes in the time (% of SG) within the hyperglycemic range;The change in time (% of SG) within the hypoglycemic range;Change of GMI;verage glucose variation;Changes in the area under the curve (AUC high) within the higher blood glucose range (SG > 10);Changes in the coefficient of variation (CV) of glucose;Changes in the area under the curve (AUC low) within the lower blood glucose range (SG < 3.9);Change of C-peptide;Changes in the standard deviation (SD) of glucose;Changes in the total daily dose of insulin (TDD);Changes in the number and duration of events within the hypoglycemic range (SG <=3.1); | — |
Countries
China
Contacts
Public ContactFeihong Luo
Children's Hospital of Fudan University
Outcome results
None listed