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

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ClinicalTrials.gov Identifier: NCT01820169
Recruitment Status : Terminated (Only 2 patients screened but none of them were enrolled.)
First Posted : March 28, 2013
Last Update Posted : September 5, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief 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.

Condition or disease Intervention/treatment Phase
Diabetes Device: ;Accu-Chek Compact Plus LCM bulk Japan Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
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
Study Start Date : April 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Single arm Device: ;Accu-Chek Compact Plus LCM bulk Japan
HbA1c would be changed by more careful control in blood glucose with SMBG.



Primary Outcome Measures :
  1. Improvement in HbA1c in 6 months [ Time Frame: 6 months ]

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


Information from the National Library of Medicine

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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


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

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01820169     History of Changes
Other Study ID Numbers: RD001551
First Posted: March 28, 2013    Key Record Dates
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