T2DM
Conditions
Interventions
Structured education group:Subjects received structured diabetes education
Sponsors
Bayer Healthcare Company Ltd
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Written Informed consent obtained before any trial-related activities T2DM patients; 2. Age > 18 years old,male or female; 3. Continuous treated with two or more oral antidiabetic drugs (OADs) for the last 3 months,and the current HbA1c>7.5%; 4. Cooperative with structured management.
Exclusion criteria
Exclusion criteria: 1. Subject with type 1 diabetes; 2. Gestational diabetes mellitus and other specific types DM; 3. Those who are unwilling to sign in ICF; 4. Subject with repeated hypoglycemia; 5. Subject with BMI>30kg/m2; 6. Impaired liver function,defined as alanine aminotransferase (ALAT)>= 2.5 or alkaline phosphatase (ALP)>= 2 times upper referenced limit times upper normal limit; 7. Females of child bearing potential 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); 8. Mental incapacity, unwillingness, or language barrier precluding adequate understanding or cooperation; 9. Any other clinically significant condition or major systemic diseases, including serious coronary heart disease, cardiovascular disease, myocardial infarction within the past 12 month; sever neurology or psychology or psychiatric disease; serious infection; actively disseminated intravascular coagulation; 10. Malignant neoplastic disease (except carcinoma in situ); 11. Current addiction to alcohol or other addictive substances.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Investigate glycemic control as measured by HbA1c change; | — |
Secondary
| Measure | Time frame |
|---|---|
| Medication compliance;total daily insulin dose;7-points of glucose;Assess diabetes self-management ability by Diabetes Management Self-Efficacy (C-DMSES);body weight;Diabetes self-management skills Diabetes self-management skills Assess diabetes self-care ability by;The satisfaction degree of structured management;The incidence of Hypoglycemia; | — |
Countries
China
Contacts
Public ContactXiaohui Guo, Linong Ji
Outcome results
None listed