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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004117
Receipt No. R000004950
Scientific Title Fushimi DIP (Driving Improvement in Patient) Study RCT on the efficacy of goal setting, use of supporting materials and intensified pharmacological intervention as means for improvement of HbA1c in the primary setting
Date of disclosure of the study information 2010/09/01
Last modified on 2014/08/25

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Basic information
Public title Fushimi DIP (Driving Improvement in Patient) Study
RCT on the efficacy of goal setting, use of supporting materials and intensified pharmacological intervention as means for improvement of HbA1c in the primary setting
Acronym Fushimi DIP (Driving Improvement in Patient) Study
Scientific Title Fushimi DIP (Driving Improvement in Patient) Study
RCT on the efficacy of goal setting, use of supporting materials and intensified pharmacological intervention as means for improvement of HbA1c in the primary setting
Scientific Title:Acronym Fushimi DIP (Driving Improvement in Patient) Study
Region
Japan

Condition
Condition Type 2 diabetes mellitus
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Investigate the efficacy of goal setting, use of supporting materials and intensified pharmacological intervention as means for improvement of HbA1c in the primary setting
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes To assess the efficacy of interventions as means of improving HbA1c levels in type2 diabetic patients in the primary setting.
Key secondary outcomes To assess the efficacy of the proposed interventions on improving the ability of patients to self-evaluate the status of their diabetes management.

To evaluate the clinical safety of the proposed interventions by assessing the change of frequency of severe hypoglycemic event.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Intervention group
The study period is equal to 12 months.
Motivational intervention period (months 0-3); during this phase, physicians will not operate any changes to prescription, alternation of dosage or frequency of visit, but will only introduce goal setting and use the supporting materials, in order to assess the efficacy of motivational intervention as factor for improving HbA1c levels in subjects.
Full intervention Period (months 4-12); during this phase, physicians will intensify the regimen according to the proposed pharmacological strategy.
Interventions/Control_2 Control group
The study period is equal to 12 months.
During the period, physicians will observe the progress of the patients following their therapeutic strategy as usual without supporting materials.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
75 years-old >
Gender Male and Female
Key inclusion criteria -Type 2 diabetes mellitus
-Patients must be treated without changes in prescription, dose and frequency of visit for the last 3 months prior the beginning of the study.
-HbA1c levels above or equal to 7% and below 10% for the last 3 months prior the beginning of the study.
-BMI below 30 for the last 3 months prior the beginning of the study.
Key exclusion criteria -Subjects who are unlikely to comply with protocol requirements, such as uncooperative attitude, inability to return for routine visits.
-Women who are pregnant, breast feeding or have the intention of becoming pregnant within duration of the study
-Subjects who are affected by asymptomatic hypoglycemia (hypoglycemia unawareness) or severe hypoglycemia.
-Subjects who present, according to physician's judgment, severe/last stage of diabetes related complications or other diseases.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mariko Oishi
Organization Oishi Clinic
Division name Director
Zip code
Address 38-1 Karekicho, Fukakusa, Fushimiku, Kyoto, Japan 612-0875
TEL 075-646-2770
Email oishi108@mbox.kyoto-inet.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mariko Oishi
Organization Fushimi Diabetes study group
Division name Fushimi DIP study head office
Zip code
Address 38-1 Karekicho, Fukakusa, Fushimiku, Kyoto, Japan 612-0875
TEL 075-646-2770
Homepage URL
Email oishi108@mbox.kyoto-inet.or.jp

Sponsor
Institute Fushimi Diabetes study group
Institute
Department

Funding Source
Organization Fushimi Medical Association
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 泉川医院・葛山医院・京町太田医院・木村医院・黒田医院・清水医院・谷口医院・田原医院・辻医院・つくだ医院・西村医院・東前医院・松下医院・依田医院・藤田医院・中津川内科診療所・辻医院・北村医院・古川医院(すべて京都市伏見区)

Other administrative information
Date of disclosure of the study information
2010 Year 09 Month 01 Day

Related information
URL releasing protocol http://www.fushimi-ishikai.jp/
Publication of results Published

Result
URL related to results and publications http://www.fushimi-ishikai.jp/
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2009 Year 02 Month 28 Day
Date of IRB
Anticipated trial start date
2009 Year 03 Month 01 Day
Last follow-up date
2010 Year 12 Month 01 Day
Date of closure to data entry
2011 Year 02 Month 01 Day
Date trial data considered complete
2011 Year 03 Month 01 Day
Date analysis concluded
2011 Year 09 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 08 Month 27 Day
Last modified on
2014 Year 08 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004950

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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