Type 1 Diabetes
Conditions
Interventions
HCL group :Hybrid Closed-Loop Insulin Delivery for two weeks,Washout Period for two weeks
CGM-Assisted Conventional Pump for two weeks
CGM-Assisted Conventional Pump:CGM-Assisted Conventional Pump for two weeks,Washout Period for two weeks,Hybrid Closed-Loop Insulin Delivery for two weeks
Sponsors
The First Affiliated Hospital of Harbin Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Age between 18 and 65 years,male and female are not limited; 2.Diagnosed with T1DM; 3.HbA1c level 3 months with a total daily insulin requirement >8 U/day at screening; 5.Subjects who understand the study procedures, comply with a diabetes-appropriate diet, perform self-monitoring of blood glucose (SMBG), and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Patients with diabetic ketoacidosis or hyperglycemia and hyperosmotic syndrome in the past 6 months; 2.History of severe hypoglycemia requiring medical assistance, causing loss of consciousness, or seizure within 6 months prior to screening; 3.Serious infections: sepsis, septicemia, septic shock; 4.Subjects presented with hyperglycemia and severe circulatory compromise or shock, who had severe cardiac, hepatic, or renal dysfunction, or suffered from other major systemic disorders; 5.Subjects with active, unfavorable skin conditions at the intended sensor insertion and insulin pump wear sites, such as diffuse subcutaneous nodules, psoriasis, or scarring;6.Patients with coagulopathy; 7.Women who are pregnant or lactating, or who plan to become pregnant during the clinical study period; 8.Subjects with planned major surgery during the study period, which in the investigator's judgment could directly interfere with insulin pump therapy; 9.Subjects with psychiatric disorders that result in a lack of self-control or an inability to communicate clearly; 10.Subjects with a history of highly irregular eating habits, substance abuse (including alcohol or drug addiction), or other similar conditions; 11.Participation in another clinical trial within 1 month prior to the screening visit; 12.Any other reason for which the Investigator considers the subject unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time within the glucose target range; | — |
Secondary
| Measure | Time frame |
|---|---|
| Glucose above target range for time;Time when glucose is below target range;Standard deviation of glucose;Coefficient of variation of glucose;Total daily insulin dose; | — |
Countries
China
Contacts
Public ContactHongyu Kuang
The First Affiliated Hospital of Harbin Medical University
Outcome results
None listed