Efficacy and Safety of Premixed Insulin Treatment in Patients With Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy and Safety of Premixed Insulin Treatment in Patients With Type 2 Diabetes Mellitus Observed by Different Type of Flash Glucose Mornitoring

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Device: Professional flash glucose mornitoring
* Device: Personal flash glucose mornitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: participate voluntarily and sign the subject informed consent before the test. 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. no acute complications such as diabetic ketoacidosis and diabetic hyperosmolar syndrome. subjects are able and willing to undergo FGM examination, diet and exercise regularly. Exclusion Criteria: patients treated with GLP-1 agonist in the last 3 months patients who are allergic to insulin. 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. a history of drug abuse and alcohol dependence within the past 5 years. used systemic hormone therapy in recent 3 months. patients with poor compliance and irregular diet and exercise. patients with infection and stress within four weeks. patients who cannot tolerate flash glucose mornitoring. patients who are pregnant, nursing or or preparing to become pregnant. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Professional flash glucose mornitoring<br>Professional flash glucose mornitoring will be used in patients once a month for 3 months to monitor glucose level. Patients can learn their blood glucose levels via capillary blood glucose tests, but nor FGM duing FGM, and doctors will adjust their anti-diabetic therapy according to their FGM results after each monitoring. | Device: Professional flash glucose mornitoring<br>* Subjects will use Professional flash glucose mornitoring once a month for 3 months.<br>|
| Active Comparator: Personal flash glucose mornitoring<br>Personal flash glucose mornitoring will be used in patients once a month for 3 months to monitor glucose level. Patients can learn their blood glucose levels via FGM duing FGM, and doctors will adjust their anti-diabetic therapy according to their FGM results after each monitoring. | Device: Personal flash glucose mornitoring<br>* Subjects will use Personal flash glucose mornitoring once a month for 3 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TIme in range | change of TIme in range | baseline and after 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | change of glycated hemoglobin | after 3 month | 
| antibody of insulin | antibody of insulin | baseline and after 3 month | 
| angrogen levels | angrogen levels | baseline and after 3 month | 
| exercise time daily | duration of exercise daily | baseline and after 3 month | 
| meal times | daily times of meal | baseline and after 3 month | 
| calorie intake | daily calorie intake | baseline and after 3 month |