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Organization Program of DiabEtes INsulIN ManaGement (OPENING)

Primary Purpose

Type 2 Diabetes Mellitus

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Structured Education
Conventional Diabetes Education
Scilin®M30
Sponsored by
Chinese Diabetes Society
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • Peking University First HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Structured Education Group

Conventional Care Group:

Arm Description

Subjects received structured diabetes education

Subjects received conventional diabetes education

Outcomes

Primary Outcome Measures

HbA1c
Investigate glycemic control as measured by HbA1c change

Secondary Outcome Measures

Assess diabetes self-management ability by Diabetes Management Self-Efficacy (C-DMSES)
Diabetes self-management skills Diabetes self-management skills Assess diabetes self-care ability by Diabetes Self-Management (SDSCA)
The satisfaction degree of structured management
total daily insulin dose
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
body weight
Medication compliance
The incidence of Hypoglycemia

Full Information

First Posted
April 15, 2011
Last Updated
October 10, 2011
Sponsor
Chinese Diabetes Society
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1. Study Identification

Unique Protocol Identification Number
NCT01338376
Brief Title
Organization Program of DiabEtes INsulIN ManaGement
Acronym
OPENING
Official Title
Organization Program of DiabEtes INsulIN ManaGement: An Open, Multi-center, Prospective, Randomized, 16-week, Controlled Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Unknown status
Study Start Date
March 2011 (undefined)
Primary Completion Date
March 2012 (Anticipated)
Study Completion Date
May 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chinese Diabetes Society

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Structured Education Group
Arm Type
Experimental
Arm Description
Subjects received structured diabetes education
Arm Title
Conventional Care Group:
Arm Type
Active Comparator
Arm Description
Subjects received conventional diabetes education
Intervention Type
Behavioral
Intervention Name(s)
Structured Education
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Conventional Diabetes Education
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Scilin®M30
Intervention Description
Subjects will be treated with Scilin®M30 twice daily
Primary Outcome Measure Information:
Title
HbA1c
Description
Investigate glycemic control as measured by HbA1c change
Time Frame
Screen,16weeks
Secondary Outcome Measure Information:
Title
Assess diabetes self-management ability by Diabetes Management Self-Efficacy (C-DMSES)
Time Frame
Screen,16weeks
Title
Diabetes self-management skills Diabetes self-management skills Assess diabetes self-care ability by Diabetes Self-Management (SDSCA)
Time Frame
Screen,16weeks
Title
The satisfaction degree of structured management
Time Frame
Screen,2weeks,4weeks,8weeks,12weeks,16weeks
Title
total daily insulin dose
Time Frame
1week,2weeks,3weeks,4weeks,6weeks,8weeks,12weeks,16weeks
Title
7-points of glucose
Description
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
Title
body weight
Time Frame
baseline,2weeks,4weeks,8weeks,12weeks,16weeks
Title
Medication compliance
Time Frame
Screen,16weeks
Title
The incidence of Hypoglycemia
Time Frame
1week,2weeks,3weeks,4weeks,6weeks,8weeks,12weeks,16weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guo Xiao Hui, Professor
Organizational Affiliation
Peking University First Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peking University First Hospital, 3A grade
Phone
+86 10 83572211
Email
dyyy@bddyyy.com.cn

12. IPD Sharing Statement

Citations:
PubMed Identifier
24279284
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.
Results Reference
derived

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Organization Program of DiabEtes INsulIN ManaGement

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