Organization Program of DiabEtes INsulIN ManaGement
OPENING
1 other identifier
interventional
1,500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 type-2-diabetes-mellitus
Started Mar 2011
Shorter than P25 for phase_4 type-2-diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 15, 2011
CompletedFirst Posted
Study publicly available on registry
April 19, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedOctober 12, 2011
April 1, 2011
1 year
April 15, 2011
October 10, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
HbA1c
Investigate glycemic control as measured by HbA1c change
Screen,16weeks
Secondary Outcomes (8)
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
Screen,16weeks
- +3 more secondary outcomes
Study Arms (2)
Structured Education Group
EXPERIMENTALSubjects received structured diabetes education
Conventional Care Group:
ACTIVE COMPARATORSubjects received conventional diabetes education
Interventions
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
Subjects will be treated with Scilin®M30 twice daily
Eligibility Criteria
You may qualify if:
- 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;
You may not qualify if:
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
Related Publications (1)
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.
PMID: 24279284DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Guo Xiao Hui, Professor
Peking University First Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 15, 2011
First Posted
April 19, 2011
Study Start
March 1, 2011
Primary Completion
March 1, 2012
Study Completion
May 1, 2012
Last Updated
October 12, 2011
Record last verified: 2011-04