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 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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004117

Enrollment

200

Registered

2010-09-01

Start date

2009-03-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes mellitus

Interventions

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

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

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
To assess the efficacy of interventions as means of improving HbA1c levels in type2 diabetic patients in the primary setting.	—

Secondary

Measure	Time frame
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.	—

Countries

Japan

Contacts

Public ContactMariko Oishi

Fushimi Diabetes study group Fushimi DIP study head office

oishi108@mbox.kyoto-inet.or.jp075-646-2770

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026