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

This study has been terminated.
(Only 2 patients screened but none of them were enrolled.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01820169
First Posted: March 28, 2013
Last Update Posted: September 5, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  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: None (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 ]

Secondary Outcome Measures:
  • 1. Comparison with historical control in HbA1c change. [ Time Frame: Baseline to 6 months ]
  • 2. Change in blood gulucose. [ Time Frame: Baseline to 6 months ]
  • 3. Change in BMI. [ Time Frame: Baseline to 6 months ]
  • 4. Occurance of sever hypoglycemia. [ Time Frame: Baseline to 6 months ]
  • 5. Doctor's opinion for Accu-Chek 360° View. [ Time Frame: Baseline to 6 months ]

Enrollment: 2
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01820169     History of Changes
Other Study ID Numbers: RD001551
First Submitted: March 11, 2013
First Posted: March 28, 2013
Last Update Posted: September 5, 2016
Last Verified: September 2016

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


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