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: January 20, 2014
Last verified: February 2013
  Purpose

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.


Condition Intervention
Diabetes
Device: ;Accu-Chek Compact Plus LCM bulk Japan

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Study on Improvement of Blood Glucose Control in Patients With Diabetes Type 2 Using SMBG

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Improvement in HbA1c in 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 80
Study Start Date: April 2013
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single arm Device: ;Accu-Chek Compact Plus LCM bulk Japan
HbA1c would be changed by more careful control in blood glucose with SMBG.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01820169

Locations
Japan
Kyoto, Japan, 612-8555
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Principal Investigator: Naoki Sakane National organization Hospital Kyoto Medical Center
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01820169     History of Changes
Other Study ID Numbers: RD001551
Study First Received: March 11, 2013
Last Updated: January 20, 2014
Health Authority: Japan: National organization Hospital Kyoto Medical Center

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 15, 2014