Study on Improvement of Blood Glucose Control in Patients With Diabetes Type 2 Using SMBG

Diabetes Clinical Trial

Official title:

Study on Improvement of Blood Glucose Control in Patients With Diabetes Type 2 Using SMBG

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01820169
• Other study ID #: RD001551
• Status: Terminated
• Phase: N/A
• First received: March 11, 2013
• Last updated: September 2, 2016
• Start date: April 2013
• Est. completion date: December 2013

Study information

• Verified date: September 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: National organization Hospital Kyoto Medical Center
• Study type: Interventional

Clinical Trial Summary

This clinical study is to determine if the use of structured testing, which is a blood glucose monitoring, via the Accu-Chek 360° View blood glucose analysis tool has a positive effect on the subjects overall glycemic control.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. Age:= and >20 years. 2. Intend to paticipate in this study after education of structured testing. 3.HbA1c:= and >7.5% in the recect 2 months.

Exclusion Criteria:

1.Pregancy. 2. Heavy complication 3. judged unsuitable by doctor

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Device:
• ;Accu-Chek Compact Plus LCM bulk Japan
HbA1c would be changed by more careful control in blood glucose with SMBG.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in HbA1c in 6 months		6 months	No
Secondary	1. Comparison with historical control in HbA1c change.		Baseline to 6 months	No
Secondary	2. Change in blood gulucose.		Baseline to 6 months	No
Secondary	3. Change in BMI.		Baseline to 6 months	No
Secondary	4. Occurance of sever hypoglycemia.		Baseline to 6 months	No
Secondary	5. Doctor's opinion for Accu-Chek 360° View.		Baseline to 6 months	No