Critical support for HIghly aged patients with diabetes by BAsal insulin therapy

UMIN ID: UMIN000001952

Registered date:09/05/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: type 2 diabetes
• Date of first enrollment: 2009/07/01
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Observational

Outcome(s)

• Primary Outcome: Blood glucose-lowering effect to the target level in elderly patients without any severe problem in management of diabetes
• Secondary Outcome: Improvement of laboratory data including HbA1c, 1,5-AG and FPG, of frequency of hypoglycemia during the trial, and of the QOL score (Diabetes Treatment Satisfaction Questionnaire:DTSQ).

Key inclusion & exclusion criteria

• Age minimum: 65years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: Patients who are ketosis-prone, who have advanced renal failure or nephritic syndrome, proliferative retinopathy, severe cardiac disease, liver damage, and active malignancies with poor prognosis. Patients who are impossible to do the self-injection therapy. Patients whom the doctors would judge as inappropriate for the inclusion should also be excluded.

Related Information

• Primary Sponsor: jikei University School of Medicine
• Secondary Sponsor: Tokyo Wemen's medical University Yachiyo, Tokyo Dental College Ichikawa, Asahi hospital, Japanese Red Cross Narita, and Funabashi Municipal Medical Center
• Source(s) of Monetary Support: Jikei University