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 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,500
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
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
Peking University First Hospital
Beijing, Beijing Municipality, China
RECRUITINGHbA1c
Investigate glycemic control as measured by HbA1c change
Time frame: Screen,16weeks
Assess diabetes self-management ability by Diabetes Management Self-Efficacy (C-DMSES)
Time frame: Screen,16weeks
Diabetes self-management skills Diabetes self-management skills Assess diabetes self-care ability by Diabetes Self-Management (SDSCA)
Time frame: Screen,16weeks
The satisfaction degree of structured management
Time frame: Screen,2weeks,4weeks,8weeks,12weeks,16weeks
total daily insulin dose
Time frame: 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
Time frame: Screen,16weeks
body weight
Time frame: baseline,2weeks,4weeks,8weeks,12weeks,16weeks
Medication compliance
Time frame: Screen,16weeks
The incidence of Hypoglycemia
Time frame: 1week,2weeks,3weeks,4weeks,6weeks,8weeks,12weeks,16weeks
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Subjects will be treated with Scilin®M30 twice daily