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Organization Program of DiabEtes INsulIN ManaGement

NCT ID: NCT01338376

Last Updated: 2011-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

1500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-05-31

Brief Summary

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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

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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.

Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Structured Education Group

Subjects received structured diabetes education

Group Type EXPERIMENTAL

Structured Education

Intervention Type BEHAVIORAL

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

Scilin®M30

Intervention Type DRUG

Subjects will be treated with Scilin®M30 twice daily

Conventional Care Group:

Subjects received conventional diabetes education

Group Type ACTIVE_COMPARATOR

Conventional Diabetes Education

Intervention Type BEHAVIORAL

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

Scilin®M30

Intervention Type DRUG

Subjects will be treated with Scilin®M30 twice daily

Interventions

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Structured 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

Intervention Type BEHAVIORAL

Conventional 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

Intervention Type BEHAVIORAL

Scilin®M30

Subjects will be treated with Scilin®M30 twice daily

Intervention Type DRUG

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese Diabetes Society

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guo Xiao Hui, Professor

Role: PRINCIPAL_INVESTIGATOR

Peking University First Hospital

Locations

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Peking University First Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Peking University First Hospital, 3A grade

Role: primary

[email protected]
+86 10 83572211

References

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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.

Reference Type DERIVED
PMID: 24279284 (View on PubMed)

Other Identifiers

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Scilin20110124

Identifier Type: -

Identifier Source: org_study_id