Type 1 diabetes mellitus (T1DM) is a chronic condition characterized by hyperglycemia resulting from absolute insulin deficiency due to autoimmune destruction of pancreatic beta cells. Following the irreversible decline in endogenous insulin production, the majority of patients with T1DM require lifelong exogenous insulin replacement therapy to maintain glycemic control.
Conditions
Interventions
Group 1:Using the Artificial Pancreas System in phase 1
Group 2:Using the Artificial Pancreas System in phase 2
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
12 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1.Aged 12 to 60 years; 2.Clinically diagnosed with type 1 diabetes; 3.Duration of diabetes >=6 months and receiving insulin replacement therapy =3 months; 4.Time in Range (TIR) <= 65% or glycated hemoglobin (HbA1c) =10% at screening; 5.Agree to continuously wear the trial devices (continuous glucose monitoring [CGM] device and insulin pump) and upload data as required; 6.Use rapid-acting insulin (100 IU/mL formulation, e.g. aspart, lispro, or glulisine insulin) and agree to perform at least one daily fingerstick blood glucose measurement; 7.Have a cohabiting guardian capable of providing emergency care support (including fingerstick blood glucose testing, glucose supplementation, or glucagon injection when necessary); 8.Participant or guardian is capable of comprehending the study protocol, willing to participate, and able to provide written informed consent;
Exclusion criteria
Exclusion criteria: 1.Body weight <12 kg or daily insulin dose <5U; 2.Presence of unresolved adverse skin conditions at the device implantation site during screening (e.g. psoriasis, dermatitis herpetiformis, rash, staphylococcal infection); 3.Intolerance to subcutaneous catheterization or adhesive tape application; 4.Inability to comply with remote data uploading or APP operation; 5.Severe systemic diseases at screening or other conditions deemed by the investigator to potentially interfere with trial outcomes; 6.Current or planned use of glucocorticoids, sex hormones, immunosuppressants, or similar medications during screening or the trial period; 7.Severe hepatic dysfunction (Child-Pugh class B-C), renal dysfunction (eGFR <30 mL/min/1.73m²), hematologic disorders, cardiac insufficiency, or related conditions; 8.Ongoing or anticipated hyperthyroidism treatment during screening or the trial period; 9.Scheduled elective surgery requiring general anesthesia or dialysis during the trial period; 10.Current participation in other interventional clinical trials (excluding observational studies) or receipt of investigational drugs/devices within the past 2 weeks; 11.Any other condition that, in the investigator’s judgment, renders the participant unsuitable for the study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c;Time in range, TIR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Questionnaire scores;TAR?TBR?mean blood glucose?SD?CV;Incidence of Hypoglycemia and Hyperglycemia-Related Acute Complications; | — |
Countries
China
Contacts
Public ContactPing Fan
Peking Union Medical College Hospital
Outcome results
None listed