NCT01820169

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable diabetes

Timeline
Completed

Started Apr 2013

Shorter than P25 for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2013

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 28, 2013

Completed
4 days until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

September 5, 2016

Status Verified

September 1, 2016

Enrollment Period

8 months

First QC Date

March 11, 2013

Last Update Submit

September 2, 2016

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

  • Improvement in HbA1c in 6 months

    6 months

Secondary Outcomes (5)

  • 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.

    Baseline to 6 months

  • 4. Occurance of sever hypoglycemia.

    Baseline to 6 months

  • 5. Doctor's opinion for Accu-Chek 360° View.

    Baseline to 6 months

Study Arms (1)

Single arm

EXPERIMENTAL
Device: ;Accu-Chek Compact Plus LCM bulk Japan

Interventions

;Accu-Chek Compact Plus LCM bulk JapanDEVICE

HbA1c would be changed by more careful control in blood glucose with SMBG.

Single arm

Eligibility Criteria

Age20 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. 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.

You may not qualify if:

  • Pregancy. 2. Heavy complication 3. judged unsuitable by doctor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Kyoto, 612-8555, Japan

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Naoki Sakane

    National organization Hospital Kyoto Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2013

First Posted

March 28, 2013

Study Start

April 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

September 5, 2016

Record last verified: 2016-09

Locations

JP(1)