Study on Improvement of Blood Glucose Control in Patients... | NCT01820169

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

NCT01820169

Sponsor

Hoffmann-La Roche

Status

Terminated

Last Update Posted

Sep 5, 2016Estimated

Enrollment

2Actual

Phase

Not Applicable

Conditions

Diabetes

Interventions

;Accu-Chek Compact Plus LCM bulk Japan

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Only 2 patients screened but none of them were enrolled.

Expanded Access Info

Start Date

Apr 2013

Primary Completion Date

Dec 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Mar 11, 2013

First Submission Date that Met QC Criteria

Mar 25, 2013

First Posted Date

Mar 28, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 2, 2016

Last Update Posted Date

Sep 5, 2016Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single arm	Experimental		Device: ;Accu-Chek Compact Plus LCM bulk Japan

Interventions

Name	Type	Description	Arm Group Labels	Other Names
;Accu-Chek Compact Plus LCM bulk Japan	Device	HbA1c would be changed by more careful control in blood glucose with SMBG.	Single arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Improvement in HbA1c in 6 months		6 months

Secondary Outcomes

Measure	Description	Time Frame
1. Comparison with historical control in HbA1c change.		Baseline to 6 months
2. Change in blood gulucose.		Baseline to 6 months
3. Change in BMI.

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Naoki Sakane	National organization Hospital Kyoto Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Kyoto		612-8555	Japan

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided