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Diabetes is a common, costly condition associated with significant morbidity and mortality. Diabetes self-management education, the process of teaching individuals to manage their diabetes, has been considered an important part. The intensive education has the capacity to deliver effective interventions to a large number of people. The investigators may be able to redirect our efforts to diabetes care and education strategies that will have a positive impact on the optimization of glycemic control and the prevention of long-term complications of diabetes, reducing the subsequent human and health care costs.
This is a prospective, randomized, open-label, controlled clinical study. 1500 subjects with Type 2 DM will be enrolled and be randomized into Structured Education Group and Conventional Education Group in 1:1 ratio. Subjects in both of the groups will be treated with ScilinĀ®M30 twice daily (30 minutes before breakfast and dinner). All the previous oral antidiabetic drugs (OAD(s)) will be discontinued except metformin and alpha-Glucosidase Inhibitors. The physician will determine the starting dose (0.3 IU/kgļ½0.4IU/kg), as well as later changes to dose according to insulin titration algorithm. The treatment duration will last 16 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Structured Education Group | Experimental | Subjects received structured diabetes education |
|
| Conventional Care Group: | Active Comparator | Subjects received conventional diabetes education |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Structured Education | Behavioral | All of the educators who are responsible for the intensive group will be trained with the standard contents before the study kick-off.
|
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | Investigate glycemic control as measured by HbA1c change | Screen,16weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Assess diabetes self-management ability by Diabetes Management Self-Efficacy (C-DMSES) | Screen,16weeks | |
| Diabetes self-management skills Diabetes self-management skills Assess diabetes self-care ability by Diabetes Self-Management (SDSCA) | Screen,16weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guo Xiao Hui, Professor | Peking University First Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Recruiting | Beijing | Beijing Municipality | 100034 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24279284 | Derived | Guo XH, Ji LN, Lu JM, Liu J, Lou QQ, Liu J, Shen L, Zhang MX, Lv XF, Gu MJ. Efficacy of structured education in patients with type 2 diabetes mellitus receiving insulin treatment. J Diabetes. 2014 Jul;6(4):290-7. doi: 10.1111/1753-0407.12100. Epub 2013 Nov 26. |
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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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|
| Conventional Diabetes Education | Behavioral | The activities of the educators who are responsible for conventional group are identical with their routine clinical practice.
|
|
| Scilin®M30 | Drug | Subjects will be treated with Scilin®M30 twice daily |
|
| The satisfaction degree of structured management | Screen,2weeks,4weeks,8weeks,12weeks,16weeks |
| total daily insulin dose | 1week,2weeks,3weeks,4weeks,6weeks,8weeks,12weeks,16weeks |
| 7-points of glucose | glucose before breakfast;glucose two hours after breakfast;glucose before lunch;glucose two hours after lunch;glucose before dinner;glucose two hours after dinner;glucose before sleep | Screen,16weeks |
| body weight | baseline,2weeks,4weeks,8weeks,12weeks,16weeks |
| Medication compliance | Screen,16weeks |
| The incidence of Hypoglycemia | 1week,2weeks,3weeks,4weeks,6weeks,8weeks,12weeks,16weeks |
| D004700 | Endocrine System Diseases |