diabetes
Conditions
Interventions
The uMH AP600 Hybrid Closed-Loop Artificial Pancreas System Group:Using the uMH AP600 Hybrid Closed-Loop Artificial Pancreas System, the medication within the pump employs ultra-rapid-acting insulin.
Conventional Insulin Pump Therapy Group:Using the traditional insulin subcutaneous pump (Unionmed uAP 550), the medication within the pump is ultra-rapid-acting insulin. The total daily insulin requir
Sponsors
Wuhan United Imaging Healthcare Surgical Technology Co., Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age range: 18 to 75 years inclusive (based on the date of signing the informed consent form), regardless of gender; 2.Inpatients with diabetes mellitus who meet one of the following criteria for insulin therapy: Patients with type 1 diabetes mellitus (T1DM) or patients with type 2 diabetes mellitus (T2DM) requiring insulin pump therapy; 3.Individuals who have signed the informed consent form and voluntarily agree to participate in this clinical trial; 4.If the subject has celiac disease, it must be confirmed by the investigator that they have received adequate treatment; 5.Able to understand the trial, cooperate with the trial procedures, and adhere to the diabetic diet and follow-up observations.
Exclusion criteria
Exclusion criteria: 1. Patients unsuitable for insulin pump therapy; 2.Patients with known or suspected insulin allergy; 3.Patients with acute diabetic complications at screening, such as diabetic ketoacidosis, hyperosmolar nonketotic coma; 4.Severe infections: sepsis, pyemia, septic shock, etc.; 5.Hyperglycemic patients with severe circulatory disorders and those with shock; patients with severe impairment of heart, liver, and kidney functions and other systemic diseases; patients with unhealed adverse skin conditions in the sensor implantation area and insulin pump wearing area (e.g., diffuse subcutaneous nodules, psoriasis, scars, etc.); 6.Patients with abnormal coagulation function; 7.Female patients who are lactating, pregnant, or planning pregnancy during the clinical trial period; 8.Patients anticipating major surgery during the study period that would directly affect insulin pump therapy; 9.Patients with mental illness, lack of self-control, or inability to express themselves clearly; 10.Patients with drug or alcohol addiction; 11.Patients who have participated in other clinical trials within the last month prior to the screening visit; 12.Patients with an expected hospitalization duration of less than 72 hours and deemed unsuitable for participation by the investigator; 13.Other situations deemed unsuitable for participation in the clinical trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time in Range(TIR)(3.9-10mmol/L); | — |
Secondary
| Measure | Time frame |
|---|---|
| Time Above Range(TAR);Time Below Range (TBR);Standard Deviation (SD);Coefficient of Variation (CV); | — |
Countries
China
Contacts
Public ContactWenzao.Sun
Xiantao first People's Hospital
Outcome results
None listed