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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01820169
First received: March 11, 2013
Last updated: June 23, 2014
Last verified: February 2013

March 11, 2013
June 23, 2014
April 2013
December 2013   (final data collection date for primary outcome measure)
Improvement in HbA1c in 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01820169 on ClinicalTrials.gov Archive Site
  • 1. Comparison with historical control in HbA1c change. [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
  • 2. Change in blood gulucose. [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
  • 3. Change in BMI. [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
  • 4. Occurance of sever hypoglycemia. [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
  • 5. Doctor's opinion for Accu-Chek 360° View. [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study on Improvement of Blood Glucose Control in Patients With Diabetes Type 2 Using SMBG
Study on Improvement of Blood Glucose Control in Patients With Diabetes Type 2 Using SMBG

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 t ool has a positive effect on the subjects overall glycemic control.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Diabetes
Device: ;Accu-Chek Compact Plus LCM bulk Japan
HbA1c would be changed by more careful control in blood glucose with SMBG.
Experimental: Single arm
Intervention: Device: ;Accu-Chek Compact Plus LCM bulk Japan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
December 2013
December 2013   (final data collection date for primary outcome measure)

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

Both
20 Years and older
Not Provided
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01820169
RD001551
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Principal Investigator: Naoki Sakane National organization Hospital Kyoto Medical Center
Hoffmann-La Roche
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP