Unique ID issued by UMIN | UMIN000003031 |
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Receipt number | R000003653 |
Scientific Title | 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 |
Date of disclosure of the study information | 2010/02/01 |
Last modified on | 2014/08/25 19:28:58 |
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
DIP(Driving Improvement in Patient) Study
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
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
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
To assess the efficacy of interventions as means of improving HbA1c levels in type 2 diabetic patients.
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
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,e.g., uncooperative attitude, inability to return for routine visits.
-Women who are pregnant, breast feeding or have the intension 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 judgement, severe/last stage of diabetes or other diseases.
1200
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 |
Japan Diabetes clinical Data Management study group (JDDM)
DIP study head office
38-1 Karekicho, Fukakusa, Fushimiku, Kyoto, Japan 612-0875
075-646-2770
oishi108@mbox.kyoto-inet.or.jp
Japan Diabetes clinical Data Management study group (JDDM)
Japan Diabetes Foundation
Non profit foundation
Japan
NO
横山内科クリニック(北海道)、加藤内科クリニック(北海道)、奥口内科クリニック(宮城県)、せいの内科クリニック(福島県)、川井クリニック(茨城県)、千葉中央メディカルセンター(千葉県)、松葉医院(神奈川県)、あらいクリニック(神奈川県)、港南台家光クリニック(神奈川県)、的場内科クリニック(神奈川県)、富山大学(富山県)、大石内科クリニック(京都府)、岩崎内科医院(山口県)、東洋鋼鈑診療所(山口県)、杉本クリニック(福岡県)、田中内科クリニック(福岡県)、内科阿部医院(大分県)、福元医院(鹿児島県)
2010 | Year | 02 | Month | 01 | Day |
http://www.jddm.jp/
Published
http://www.jddm.jp/
Completed
2009 | Year | 02 | Month | 28 | Day |
2009 | Year | 03 | Month | 01 | Day |
2011 | Year | 02 | Month | 01 | Day |
2011 | Year | 03 | Month | 01 | Day |
2011 | Year | 04 | Month | 01 | Day |
2011 | Year | 10 | Month | 01 | Day |
2010 | Year | 01 | Month | 13 | Day |
2014 | Year | 08 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003653
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