DiabetesNCT01820169
Study on Improvement of Blood Glucose Control in Patients With Diabetes Type 2 Using SMBG
A study testing ;Accu-Chek Compact Plus LCM bulk Japan in people with Diabetes, run by Hoffmann-La Roche at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- ;Accu-Chek Compact Plus LCM bulk Japan
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteJapan
- Study dates
- Apr 2013to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 1.Pregancy. 2. Heavy complication 3. judged unsuitable by doctor
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Diabetes
- Being tested
- ;Accu-Chek Compact Plus LCM bulk Japan
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
;Accu-Chek Compact Plus LCM bulk JapanDevice
HbA1c would be changed by more careful control in blood glucose with SMBG.
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | Not described Receives: Device: ;Accu-Chek Compact Plus LCM bulk Japan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in HbA1c in 6 months
Measured: 6 months
Secondary outcomes (5)
1. Comparison with historical control in HbA1c change.
Measured: Baseline to 6 months
2. Change in blood gulucose.
Measured: Baseline to 6 months
3. Change in BMI.
Measured: Baseline to 6 months
4. Occurance of sever hypoglycemia.
Measured: Baseline to 6 months
5. Doctor's opinion for Accu-Chek 360° View.
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2013 (estimated)
- Study startApr 2013
- Primary completionDec 2013
- Study completionDec 2013
Why it stopped: Only 2 patients screened but none of them were enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Naoki Sakane, Principal investigator, National organization Hospital Kyoto Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01820169
- Sponsor's protocol ID
- RD001551
- Status last verified
- Sep 2016
- First submitted
- 11 Mar 2013
- Last updated
- 5 Sep 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Improvement of Blood Glucose Control in Patients With Diabetes Type 2 Using SMBG
- ClinicalTrials.gov ID
- NCT01820169
- Acronym / sponsor ID
- RD001551
- Conditions
- Diabetes
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Only 2 patients screened but none of them were enrolled.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 28 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Device: ;Accu-Chek Compact Plus LCM bulk Japan |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 1.Pregancy. 2. Heavy complication 3. judged unsuitable by doctor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ;Accu-Chek Compact Plus LCM bulk JapanHbA1c would be changed by more careful control in blood glucose with SMBG. | Device | Single arm |
Primary outcome
Improvement in HbA1c in 6 months
Time frame: 6 months
5 secondary outcomes
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
Results and safety
The study was stopped early (reason given: Only 2 patients screened but none of them were enrolled.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naoki Sakane principal investigator
National organization Hospital Kyoto Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ;Accu-Chek Compact Plus LCM bulk Japan in people with Diabetes, run by Hoffmann-La Roche at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Only 2 patients screened but none of them were enrolled.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in HbA1c in 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2016.