Type 1 Diabetes
Conditions
Interventions
Group 1:phase I: insulin glargine
phase II: insulin degludec
Group 2:phase I: insulin degludec
phase II: insulin glargine.
Sponsors
The First Affiliated Hospital of Harbin Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. At the time of screening, the age of patients >= 18 years old, male and female are not limited; 2. The subjects were all type 1 diabetic patients, the serum C-peptide concentration was confirmed as low level (< 0.07 nmol / L) at least twice; 3. The subjects who had been continuously using the basic plus meal insulin treatment scheme in the past 3 months; 4. Patients whose HbA1c must meet the standard: 6.9% <= HbAlc <= 10.0%; 5. Body mass index (BMI) was 18.0-35.0kg/m2; 6. Patients who can understand and abide by the test process, voluntarily participate in the test and provide informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with diabetic ketoacidosis or diabetic hyperosmotic nonketotic coma in the past 6 months; 2. Patients with severe infection, surgery or severe trauma in the past month; 3. Patients with any of the following history and conditions of heart disease in the past 6 months: (1) Decompensated cardiac insufficiency (NYHA grade III or IV); (2) Unstable angina, myocardial infarction, coronary artery bypass grafting or coronary stent implantation; (3) Uncontrolled or serious arrhythmias (such as long QT interval syndrome) are not suitable for this clinical trial according to the evaluation of researchers; 4. Patients with hemorrhagic stroke or ischemic stroke in the past 6 months who are not suitable for this clinical trial as assessed by the researchers; 5. At present, patients with any disease that may cause hemolysis or red blood cell instability and affect the detection of glycosylated hemoglobin; 6. Patients with a history of acute or chronic pancreatitis; 7. Liver function was damaged, AST / ALT > 3 times of the upper limit of reference range, total bilirubin > 1.5 times of the upper limit of reference range; 8. Renal insufficiency, glomerular filtration rate (EGFR) < 60ml / min / 1.73m2; 9. Patients with diseases that may cause tissue hypoxia (especially the deterioration of acute disease or chronic respiratory disease); 10. Patients with severe chronic gastrointestinal diseases in malnutrition, hunger or weakness; 11. Patients with adrenal dysfunction; 12. Patients with habitual heavy drinkers; 13. Patients with dehydration or gastrointestinal symptoms, such as diarrhea or vomiting related to dehydration risk; 14. Patients with malignant tumors requiring treatment in the past 5 years; 15. Patients who have received or are receiving any other investigational drug in the past 3 months; 16. Patients with serious mental illness or language disorder who are unwilling or unable to fully understand cooperation; 17. Patients who are or may be allergic to insulin or similar drugs; 18. Pregnant or lactating women; 19. Patients who have used CGMS system in the past 6 months; 20. Patients who are receiving systemic glucocorticoid treatment (oral and intravenous) due to any disease; 21. Patients taking vitamin C and aspirin with daily dose greater than 60mg; 22. Honeymoon patients with type 1 diabetes; 23. Patients known to be allergic to medical grade glue; 24. The researchers believe that the subjects have other important diseases that are not suitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 24-h mean glucose levels;standard deviations (SD) of 24-h glucose levels;the coefficient of variation(CV) of 24-h glucose levels;mean amplitude of glycemic excursions (MAGE);largest amplitude of glycemic excursions (LAGE);the mean of daily difference (MODD);time in hypoglycemia (7.8mmol/L) during a 24-h period;time in hyperglycemia (>10.0mmol/L) during a 24-h period;time in hyperglycemia (>13.9mmol/L) during a 24-h period; | — |
Secondary
| Measure | Time frame |
|---|---|
| HbAlc;insulin dose;hypoglycemic event (frequency of nocturnal hypoglycemia);self-perceived satisfaction rating scale; | — |
Countries
China
Contacts
Public ContactKuang Hongyu
The First Affiliated Hospital of Harbin Medical University
Outcome results
None listed