Diabetes
Conditions
Interventions
Single arm test:Artificial pancreas therapy
Sponsors
The First Medical Center of the Chinese People's Liberation Army General Hospital
Eligibility
Sex/Gender
All
Age
14 Years to 85 Years
Inclusion criteria
Inclusion criteria: (1) Male and female, =14 years old (subject to the date of signing the informed consent); (2) Clinical diagnosis of diabetes; (3) The hemoglobin A1c (HbA1c) of the subjects was less than 10.0% at the screening visit; (4) At the time of screening, subjects had been receiving insulin therapy for more than 3 months and had maintained a stable dose for 2 weeks prior to screening (medical documents within 2 weeks prior to screening are required); (5) Expected daily insulin demand after insulin pump treatment > 8 units/day (total daily dose); (6) Those who are able to follow a diabetic diet, conduct self-monitoring of blood sugar and voluntarily sign an informed consent letter.
Exclusion criteria
Exclusion criteria: (1) Diabetic ketoacidosis (DKA) and hyperglycemia hyperosmotic pressure syndrome (HHS) were present in the subjects during screening; (2) The subjects had secondary diabetes, such as post-pancreatectomy diabetes, hepatic diabetes, renal diabetes, thyroid diabetes, etc.; (3) There are adverse skin conditions (such as diffuse subcutaneous nodules, psoriasis, scars, stretch marks, etc.) in the area where the disposable grape probe and insulin pump subcutaneous infusion set are implanted; (4) Coagulation function APTT (activated partial thromboplastin time) or PT (prothrombin time) test results greater than 1.5 times the upper limit of normal value; (5) The following cardiovascular events occurred within 8 weeks prior to screening: a) decompensated cardiac insufficiency (New York College of Cardiology [NYHA] Class III or IV); b) Unstable angina is diagnosed; c) History of myocardial infarction, coronary artery bypass grafting, or coronary stent implantation; d) Uncontrolled or severe arrhythmia; (6) Subjects were being treated for hyperthyroidism at the time of screening; (7) Use of glucocorticoid drugs (excluding topical or inhaled preparations) for a total time of more than 7 days in the 8 weeks before screening; (8) 120 hours before screening, subjects were taking a DPP-4 inhibitor, liraglutide (Victoza or another GLP-1 agonist), or englaglizin (Invokana or another SGLT2 inhibitor); (9) The subject has a history of present disease with known vision and hearing, which will directly affect the subject's participation in the study and the safe execution of all test procedures (at the discretion of the investigator); (10) Use of immunosuppressants, cytotoxic drugs, systemic steroid drugs (excluding topical or inhaled preparations) for more than 7 days in the 3 months before screening; (11) The subject has mental illness, no self-control, and cannot express clearly; (12) Major surgery is expected during the trial period that will directly affect insulin pump therapy; (13) Hematocrit (Hct) was lower than the normal laboratory reference range; (14) The subjects currently have extremely irregular diets, such as overeating, dieting, anorexia, and alcoholism (men drink no more than 25g of alcohol a day, women no more than 15g); (15) Serious bleeding factors affecting venous blood collection; (16) Glomerular filtration rate (eGFR) < 30; (17) Pregnant and lactating women; Fertile female subjects who had a family plan during the trial or who could not commit to using one or more contraceptive methods; (18) any serious systemic disease determined by the investigator or any other disease that the investigator believes may interfere with the results of this study, including but not limited to mental illness, immune system disease, malignancy, etc.; (19) Participating in other clinical trials within 1 month before the screening visit; (20) There were other conditions that the researchers determined were not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time in the target blood glucose range: 3.9mmol /L=SG= 10mmol /L; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes of HBA1c in interview-9 and interview-4;Time in hypoglycemia range: SG 10mmol/L, 13.9mmol/L, 19.4mmol/L;Standard deviation of blood glucose;The coefficient of variation of blood sugar;Changes in body weight from the initiation to the end of the treatment period;Changes in the diabetes treatment questionnaire scores (DTSQs and SUS) of visit 9 and visit 4; | — |
Countries
China
Contacts
Public ContactMu Yiming
The First Medical Center of the Chinese People's Liberation Army General Hospital
Outcome results
None listed