Unique ID issued by UMIN | UMIN000004117 |
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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 |
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
Fushimi DIP (Driving Improvement in Patient) Study
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
Fushimi DIP (Driving Improvement in Patient) Study
Japan |
Type 2 diabetes mellitus
Endocrinology and Metabolism |
Others
NO
Investigate the efficacy of goal setting, use of supporting materials and intensified pharmacological intervention as means for improvement of HbA1c in the primary setting
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
To assess the efficacy of interventions as means of improving HbA1c levels in type2 diabetic patients in the primary setting.
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.
Interventional
Parallel
Randomized
Cluster
Open -no one is blinded
Active
NO
NO
Numbered container method
2
Treatment
Behavior,custom |
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.
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.
20 | years-old | <= |
75 | years-old | > |
Male and Female
-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.
-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.
200
1st name | |
Middle name | |
Last name | Mariko Oishi |
Oishi Clinic
Director
38-1 Karekicho, Fukakusa, Fushimiku, Kyoto, Japan 612-0875
075-646-2770
oishi108@mbox.kyoto-inet.or.jp
1st name | |
Middle name | |
Last name | Mariko Oishi |
Fushimi Diabetes study group
Fushimi DIP study head office
38-1 Karekicho, Fukakusa, Fushimiku, Kyoto, Japan 612-0875
075-646-2770
oishi108@mbox.kyoto-inet.or.jp
Fushimi Diabetes study group
Fushimi Medical Association
Self funding
Japan
NO
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)
2010 | Year | 09 | Month | 01 | Day |
http://www.fushimi-ishikai.jp/
Published
http://www.fushimi-ishikai.jp/
Completed
2009 | Year | 02 | Month | 28 | Day |
2009 | Year | 03 | Month | 01 | Day |
2010 | Year | 12 | Month | 01 | Day |
2011 | Year | 02 | Month | 01 | Day |
2011 | Year | 03 | Month | 01 | Day |
2011 | Year | 09 | Month | 01 | Day |
2010 | Year | 08 | Month | 27 | Day |
2014 | Year | 08 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004950
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