Type 2 Diabetes Mellitus
Conditions
Brief summary
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
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.
Interventions
BEHAVIORALStructured Education
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
BEHAVIORALConventional Diabetes Education
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
DRUGScilin®M30
Subjects will be treated with Scilin®M30 twice daily
Sponsors
Chinese Diabetes Society
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | Screen,16weeks | Investigate glycemic control as measured by HbA1c change |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Assess diabetes self-management ability by Diabetes Management Self-Efficacy (C-DMSES) | 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 | — |
| 7-points of glucose | Screen,16weeks | 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 |
Countries
China
Outcome results
None listed