Type 2 Diabetes
Conditions
Brief summary
The aim of the study is to investigate the efficacy and safety of premixed insulin treatment in patients With type 2 diabetes mellitus using professional and personal Flash Glucose Mornitoring.
Detailed description
Professional and personal Flash Glucose Mornitoring will be used in patients with type 2 diabetes who are treated with premixed insulin. The frequency of hypogycemia and the blood glucose control will be analyzed by flash glucose mornitoring once a month for 3 months and doctors will adjust the hypoglycemia treatment according to the results every month. HbA1c, glycemic variation, beta-cell function and androgen levels will be measured.
Interventions
DEVICEProfessional flash glucose mornitoring
Subjects will use Professional flash glucose mornitoring once a month for 3 months.
DEVICEPersonal flash glucose mornitoring
Subjects will use Personal flash glucose mornitoring once a month for 3 months.
Sponsors
Wuxi Hospital of Traditional Chinese Medicine
Wuxi People's Hospital Affiliated to Nanjing Medical University
Huai'an Second People's Hospital and the Affiliated Huai'an Hospital of Xuzhou Medical University
The Affiliated Suqian First People's Hospital of Nanjing Medical University
Nanjing First Hospital, Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. participate voluntarily and sign the subject informed consent before the test. 2. for patients with type 2 diabetes who met WHO1999 diagnostic criteria, subcutaneous injection with premix insulin Bid/Tid, single drug and/or combination of oral hypoglycemic drugs, the treatment regimen was stable for more than 2 months. 3. no acute complications such as diabetic ketoacidosis and diabetic hyperosmolar syndrome. 4. subjects are able and willing to undergo FGM examination, diet and exercise regularly.
Exclusion criteria
1. patients treated with GLP-1 agonist in the last 3 months 2. patients who are allergic to insulin. 3. impaired liver and renal function, ALT 2.5 times higher than the upper limit of normal value;Serum creatinine was 1.3 times higher than the upper limit of normal. 4. a history of drug abuse and alcohol dependence within the past 5 years. 5. used systemic hormone therapy in recent 3 months. 6. patients with poor compliance and irregular diet and exercise. 7. patients with infection and stress within four weeks. 8. patients who cannot tolerate flash glucose mornitoring. 9. patients who are pregnant, nursing or or preparing to become pregnant. 10. any other apparent condition or comorption as determined by the investigator, such as severe heart and lung disease, endocrine disease, neurological disease, tumor disease, other pancreatic disease, history of mental illness.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TIme in range | baseline and after 3 month | change of TIme in range |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| angrogen levels | baseline and after 3 month | angrogen levels |
| exercise time daily | baseline and after 3 month | duration of exercise daily |
| antibody of insulin | baseline and after 3 month | antibody of insulin |
| calorie intake | baseline and after 3 month | daily calorie intake |
| HbA1c | after 3 month | change of glycated hemoglobin |
| meal times | baseline and after 3 month | daily times of meal |
Countries
China
Outcome results
None listed