Organization Program of DiabEtes INsulIN ManaGement

Study Overview
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Brief Summary
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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.

Detailed Description
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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 Scilin®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/kg～0.4IU/kg), as well as later changes to dose according to insulin titration algorithm. The treatment duration will last 16 weeks.

Official Title
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Organization Program of DiabEtes INsulIN ManaGement: An Open, Multi-center, Prospective, Randomized, 16-week, Controlled Clinical Study

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Behavioral: Structured Education
* Behavioral: Conventional Diabetes Education
* Drug: Scilin®M30


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written Informed Consent obtained before any trial-related activities Type 2 DM subjects; Age > 18 years old,male or female; Continuous treated with two or more oral antidiabetic drugs (OADs) for the last 3 months,and the current HbA1c>7.5%; Cooperative with structured management; Exclusion Criteria: Subjects with type 1 diabetes; Gestational diabetes mellitus and other specific types DM; Those who are unwilling to sign in ICF; Subjects with repeated hypoglycemia; Subjects with BMI>30kg/m2; Impaired liver function,defined as alanine aminotransferase (ALAT)>= 2.5 or alkaline phosphatase (ALP)>= 2 times upper referenced limit times upper normal limit; Females of childbearing age who are pregnant, breast-feeding or have the intention of becoming pregnant or not using adequate contraceptive methods throughout the trial (adequate contraceptive measures as required by local law or practice); Mental incapacity, unwillingness, or language barrier precluding adequate understanding or cooperation; Any other clinically significant condition or major systemic diseases, including serious coronary heart disease, cardiovascular disease, myocardial infarction within the past 12 months; severe neurology or psychology or psychiatric diseases; serious infection; actively disseminated intravascular coagulation; Malignant neoplastic diseases (except carcinoma in situ); Current addiction to alcohol or other addictive substances;

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Structured Education Group<br>Subjects received structured diabetes education | Behavioral: Structured Education<br>* All of the educators who are responsible for the intensive group will be trained with the standard contents before the study kick-off. Educator Activities: insulin injection, SMBG instruction, self-learned manuals, periodic assessment for subjects, subject counseling, self-care education (healthy eating, exercise, weight control), prevention and treatment of hypoglycemia complication education ,newsletter delivered by SMS Physician Activity: frequent insulin titration<br>Drug: Scilin®M30<br>* Subjects will be treated with Scilin®M30 twice daily<br>|
| Active Comparator: Conventional Care Group:<br>Subjects received conventional diabetes education | Behavioral: Conventional Diabetes Education<br>* The activities of the educators who are responsible for conventional group are identical with their routine clinical practice. Educator Activities: insulin injection, SMBG instruction, healthy eating , prevention and treatment of hypoglycemia Physician Activity: less frequent insulin titration<br>Drug: Scilin®M30<br>* Subjects will be treated with Scilin®M30 twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | Investigate glycemic control as measured by HbA1c change | Screen,16weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |