UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004117
Receipt number 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 19:39:43

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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 or person

Institute

Fushimi Diabetes study group

Institute

Department

Personal name



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

Value
https://center6.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