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| Name | Class |
|---|---|
| Wuxi Hospital of Traditional Chinese Medicine | UNKNOWN |
| Wuxi People's Hospital Affiliated to Nanjing Medical University | UNKNOWN |
| Huai'an Second People's Hospital and the Affiliated Huai'an Hospital of Xuzhou Medical University |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Professional flash glucose mornitoring | Placebo Comparator | 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. |
|
| Personal flash glucose mornitoring | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Professional flash glucose mornitoring | Device | Subjects will use Professional flash glucose mornitoring once a month for 3 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| TIme in range | change of TIme in range | baseline and after 3 month |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | change of glycated hemoglobin | after 3 month |
| antibody of insulin | antibody of insulin | baseline and after 3 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jianhua Ma, MD | The First Affiliated Hospital with Nanjing Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanjing First Hospital | Nanjing | Jiangsu | 210012 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40620795 | Derived | Kong D, Shen Z, Jiang L, Xie X, Yan R, Jing T, Hu Y, Ma J. The effects of vildagliptin on glycemic variability in patients with type 2 diabetes on premixed insulin therapy. Front Endocrinol (Lausanne). 2025 Jun 20;16:1508918. doi: 10.3389/fendo.2025.1508918. eCollection 2025. | |
| 35222287 | Derived | Yan RN, Cai TT, Jiang LL, Jing T, Cai L, Xie XJ, Su XF, Xu L, He K, Cheng L, Cheng C, Liu BL, Hu Y, Ma JH. Real-Time Flash Glucose Monitoring Had Better Effects on Daily Glycemic Control Compared With Retrospective Flash Glucose Monitoring in Patients With Type 2 Diabetes on Premix Insulin Therapy. Front Endocrinol (Lausanne). 2022 Feb 10;13:832102. doi: 10.3389/fendo.2022.832102. eCollection 2022. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| The Affiliated Suqian First People's Hospital of Nanjing Medical University | UNKNOWN |
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| Personal flash glucose mornitoring | Device | Subjects will use Personal flash glucose mornitoring once a month for 3 months. |
|
| 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 |
| 35002984 | Derived | Cai T, Hu Y, Ding B, Yan R, Liu B, Cai L, Jing T, Jiang L, Xie X, Wang Y, Wang H, Zhou Y, He K, Xu L, Chen L, Cheng C, Ma J. Effect of Metformin on Testosterone Levels in Male Patients With Type 2 Diabetes Mellitus Treated With Insulin. Front Endocrinol (Lausanne). 2021 Dec 24;12:813067. doi: 10.3389/fendo.2021.813067. eCollection 2021. |
| D004700 | Endocrine System Diseases |