Clinical trial NCT01338376: Organization Program of DiabEtes INsulIN ManaGement
Official title: Organization Program of DiabEtes INsulIN ManaGement: An Open, Multi-center, Prospective, Randomized, 16-week, Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Chinese Diabetes Society
Sponsor class: OTHER
First posted: 2011-04-19
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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;

Primary outcomes:
measure: HbA1c
timeFrame: Screen,16weeks
Secondary outcomes:
measure: Assess diabetes self-management ability by Diabetes Management Self-Efficacy (C-DMSES)
timeFrame: Screen,16weeks
measure: Diabetes self-management skills Diabetes self-management skills Assess diabetes self-care ability by Diabetes Self-Management (SDSCA)
timeFrame: Screen,16weeks
measure: The satisfaction degree of structured management
timeFrame: Screen,2weeks,4weeks,8weeks,12weeks,16weeks
measure: total daily insulin dose
timeFrame: 1week,2weeks,3weeks,4weeks,6weeks,8weeks,12weeks,16weeks
measure: 7-points of glucose
timeFrame: Screen,16weeks
measure: body weight
timeFrame: baseline,2weeks,4weeks,8weeks,12weeks,16weeks
measure: Medication compliance
timeFrame: Screen,16weeks
measure: The incidence of Hypoglycemia
timeFrame: 1week,2weeks,3weeks,4weeks,6weeks,8weeks,12weeks,16weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
Study officials:
affiliation: Peking University First Hospital
name: Guo Xiao Hui, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.