Type 1 diabetes
Conditions
Interventions
Intervention group:Participants will receive treatment with an artificial pancreas system. The artificial pancreas system consists of a continuous glucose monitoring device, an insulin pump, and a glu
Control group:The sensor-enhanced pump (SAP) is used, allowing patients to manually adjust the insulin dosage based on real-time blood glucose monitoring results. It does not have an automatic adjustm
Sponsors
The First Affiliated Hospital of University of Science and Technology of China
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosed with type 1 diabetes mellitus (T1DM) according to the American Diabetes Association (ADA) criteria, with a disease duration of more than 1 year, receiving insulin therapy for at least 1 year, and having met the above criteria before the screening visit. 2. Age 18 =3 months or multiple daily insulin injections (MDI) for >=6 months before the screening visit, and willing to switch to the study-specified insulin pump therapy during the trial. 4. Average glycated hemoglobin (HbA1c) level <10.5% (91 mmol/mol) within the 6 months before the screening visit (at least one measurement performed). 5. For female participants, not currently pregnant and agree to use contraceptive measures during the study participation. 6. Once using the study-specified continuous glucose monitoring (CGM) system, subjects must agree to discontinue use of any personal CGM devices during the clinical trial. 7. Willing to use the study-specified insulin infusion system during the clinical trial and not to adjust insulin infusion settings on their own. 8. Willing to use the study-specified insulin during the trial and not to start any other insulin preparations. 9. Agree not to start any non-insulin antidiabetic drugs during the study period. 10. The investigator confirms that the subject is able to successfully operate all study devices and has the ability to comply with the protocol. 11. Signed informed consent has been obtained.
Exclusion criteria
Exclusion criteria: 1. Diabetes types other than type 1 diabetes mellitus, including type 2 diabetes mellitus, gestational diabetes mellitus(GDM), or specific types of diabetes; 2. Acute or severe chronic diabetic complications, such as severe hypoglycemia, diabetic ketoacidosis, hyperosmolar coma, or lactic acidosis, occurring within 3 months before enrollment; 3. Use of any non-insulin glucose-lowering medications within 3 months before enrollment, except metformin, including GLP-1 receptor agonists, pramlintide, DPP-4 inhibitors, SGLT-2 inhibitors, and sulfonylureas; 4. Current or planned use of steroidal drugs or non-steroidal anti-inflammatory drugs(NSAIDs); 5. Currently pregnant, planning pregnancy, or breastfeeding; 6. Hemophilia or other bleeding disorders; 7. Known or suspected allergy to the insulin used in the study; 8. Allergy to adhesive materials; 9. Presence of any serious disease that, in the investigator’s judgment, may affect the study results, such as severe cardiac disease, cerebrovascular infarction, malignancy, renal disease(eGFR <45 mL/min), severe skin disease, visual or hearing impairment, psychiatric or psychological disorders, or cognitive impairment; 10. Any concomitant condition or factor that may affect glycated hemoglobin measurement; 11. Participation in another clinical study within 1 month before enrollment or during the study visits; 12. Considered by the investigator to be unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the between-group difference in the change in TIR (70–180 mg/dL) from baseline to Week 24; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Glycated Hemoglobin A1c levels;The between-group difference in the change in TTIR(70–140 mg/dL)from baseline to Week 24;The between-group difference in the change in TBR 140 mg/dL from baseline to Week 24;The between-group difference in the change in Mean Glucose from baseline to Week 24;The between-group difference in the change in Standard Deviation of Glucose from baseline to Week 24;The between-group difference in the change in Coefficient of Variation of Glucose from baseline to Week 24;The between-group difference in the change in Low Blood Glucose Index from baseline to Week 24;The between-group difference in the change in High Blood Glucose Index from baseline to Week 24;The between-group difference in the change in Glucose Management Indicator from baseline to Week 24;The between-group difference in the change in TBR 180 mg/dL from baseline to Week 24; | — |
Countries
China
Contacts
Public ContactWeng Jianping
The First Affiliated Hospital of University of Science and Technology of China
Outcome results
None listed