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
  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 t ool 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: June 23, 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 July 28, 2014