Diabetes
Conditions
Interventions
All subjects:Wearing a Tubeless closed-loop insulin management system
Sponsors
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
Eligibility
Sex/Gender
All
Age
14 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1)Subject is aged 14-75 years (based on the date of signing the informed consent form), including all genders at the time of screening. 2) Subject has a clinical diagnosis of type 1 diabetes* or type 2 diabetes requiring long-term insulin use, with a disease duration of 6 months or more. * Patients with type 1 diabetes must meet the following conditions: a) Subject has a clinical diagnosis of type 1 diabetes as determined by a specialist; b) Any of the following is met: a. Age at onset is below 15 years, or b. There is no overweight or obesity at onset, or c. There is a history of diabetic ketoacidosis, or d. The highest random C-peptide is below 200 pmol/L. c) Any of the following is met: a. The subject starts and continuously uses insulin therapy after diagnosis (except for pancreas or insulin transplantation), or b.The subject’s insulin autoantibodies are positive. 3)Subject receives a daily regimen of premixed insulin or basal combined with meal insulin and has a treatment history of 3 months or more, with a daily insulin requirement between 10U - 100U (inclusive). 4)Subject has a glycosylated hemoglobin (HbA1c) level of = 10% at the time of screening. 5)Subject’s thyroid-stimulating hormone (TSH), Free T3, and Free T4 are within twice the normal laboratory reference range at the time of screening. Laboratory results from the past 6 months can be used for screening. 6)Subject is willing to continuously wear the investigational device and use fast-acting insulin such as NovoRapid (Insulin Aspart) or Humalog (Insulin Lispro) throughout the duration of the trial. 7)Subject is willing to perform at least one finger-stick blood glucose measurement per day. 8)Subject is willing to upload data from the investigational device. 9)Subject is willing to sign an informed consent form and learn about basic diabetes management and the use of the trial device system.
Exclusion criteria
Exclusion criteria: 1)Subject has a history of severe hypoglycemia resulting in any of the following within the 6 months prior to screening: a. Medical assistance (i.e. paramedics, emergency room (ER) or hospitalization) b. Coma c. Seizures d. Repeated episodes of hypoglycemia or unconscious hypoglycemic episodes 2)Subject has hyperglycemia with acute complications such as diabetic ketoacidosis (DKA) or non-ketotic hyperosmolar syndrome that are unresolved or accompanied by severe circulatory disorders at the time of screening. 3)Subject has any unresolved adverse skin condition at the implant site (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection). 4)Subject is is unable to tolerate subcutaneous infusion needles or adhesive tape, or has edema. 5)Subject has serious complications of diabetes during screening: such as proliferative diabetic retinopathy, history of kidney transplantation, or active peripheral vascular diseases (e.g., diseases that have led to amputation, chronic foot ulcers, intermittent claudication or requiring bypass surgery or angioplasty). 6)Subject has active liver disease with severe liver and kidney dysfunction. 7)Subject’s alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels are more than 2.5 times the upper limit of normal values at the time of screening. 8)Subject has an estimated glomerular filtration rate (eGFR) of < 45 ml/(min·1.73m²). 9)Subject’s activated partial thromboplastin time (APTT) or prothrombin time (PT) test results are greater than 1.5 times the upper limit of normal values at the time of screening. 10)Subject has had any of the following cardiovascular events within 1 year of screening: myocardial infarction, cardiac insufficiency (NYHA class III/IV), unstable angina, coronary artery bypass surgery, coronary artery stenting, angina, congestive heart failure, ventricular arrhythmias, cerebrovascular accident (including ischemic stroke, hemorrhagic stroke, and transient ischemic attack), or thromboembolic disease. 11)Subjects had severe systemic diseases or other diseases that the investigators believe may interfere with the results of this study at the time of screening, including but not limited to psychiatric disorders, hematological diseases, systemic lupus erythematosus, rheumatoid arthritis, autoimmune hemolytic anemia, and malignant tumors, etc. 12)Subject has a history of drug abuse or alcoholism. 13)Subject has a diagnosis of adrenal insufficiency. 14)Subject is being treated or needs to be treated for hyperthyroidism during the trial. 15)Subject has used any oral, injectable, or intravenous (IV) glucocorticoids within 8 weeks prior to screening or plans to use them during the trial. 16)Subject has used any oral, injectable anticoagulants, or antiplatelet drugs within the 8 weeks prior to screening or plans to use them during the trial. 17)Subject has not undergone a 7-day washout period for non-insulin medications such as metformin, thiazolidinediones, alpha-glucosidase inhibitors, sulfonylureas, meglitinides, pramlintide, DPP-4 inhibitors, SGLT2 inhibitors, or GLP-1 receptor agonists at the time of enrollment. 18)Subject’s hematocrit (HCT) is below 10% of the laboratory's normal range at the time of screening. 19)Subject plans to undergo elective surgery requiring general anesthesia or dialysis during the trial period. 20)Subject lives alone and lacks emergency care support, which includes blood glucose testing, necessary glucose suppleme
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of the percentage of Time in Range (TIR) [3.9-10 mmol/L];Changes in hemoglobin a1c (HbA1c); | — |
Secondary
| Measure | Time frame |
|---|---|
| Time Below Range (TBR) : 10 mmol/L,>13.9 mmol/L;Mean blood glucose;Glucose variability : Standard deviation SD, coefficient of variation CV;Total daily dose of insulin (TDD);weight;Percentage of time spent in automatic mode (Auto Mode) during the closed-loop period;Subgroup analysis of sensor glucose metrics including the percentage of time in range (TIR), the percentage of time below range (TBR), the percentage of time above range (TAR) will be performed based on HbA1c level (8%) at the time of screening. ;usability study; | — |
Countries
China
Contacts
Public ContactYan Bi
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
Outcome results
None listed