Diabetes Mellitus, Type 2NCT00401622
Clinical Benefits of a Blood Glucose Monitoring System in Patients With Type 2 Diabetes
A study testing OneTouch® Ultra®2 System in people with Diabetes Mellitus, Type 2, run by LifeScan at 18 sites in 3 countries.
Trial summary
Clinical benefits of the OneTouch® Ultra®2 BGMS versus standard BGMS during 52 weeks of use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- OneTouch® Ultra®2 System
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 18 sitesin 3 countries
- Study dates
- 1 Oct 2006to 1 Jan 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current diagnosis of type 2 diabetes
- Diagnosed at least 3 months prior to the start of the study but not more than 15 years from the start of the study
- Stable regimen (i.e., no changes in therapeutic regimen) for the past three months
- Baseline HbA1c of 7.0 to 8.9%, inclusive
Who cannot join
- Using insulin
- Using oral agents that target post-prandial hyperglycemia (Note: These medications may be added during the study)
- Known history of anemia or disorders associated with anemia
- Has previously used the devices being tested in the study
Trial locations and contacts
18 sites in 3 countries.
18 sites in 3 countries
United States10 sites
Study site
Dawsonville, Georgia, 30534
Study site
East Syracuse, New York, 13057
Study site
Endwell, New York, 13760
Study site
Hollywood, Florida, 33023
Study site
Phoenix, Arizona, 85018
Study site
San Antonio, Texas, 78229
Study site
San Diego, California, 92161
Study site
Syracuse, New York, 13210
Study site
Whitehouse Station, New Jersey, 08889
Study site
Wilmington, Delaware, 19805
United Kingdom6 sites
Study site
Buckshaw Village, Chorley, PR7 7NA
Study site
Claygate, Surrey, KT10 OSA
Study site
Glasgow, Scotland, G20 0XA
Study site
Llanishen, Cardiff, CF145GJ
Study site
Lloyd Street North, Manchester, M15 6SX
Study site
Reading, Berkshire, RG2 7AG
Canada2 sites
Study site
Oshawa, Ontario, L1H1017
Study site
Windsor, Ontario, N8W3P6
About this study
Clinical benefits of the OneTouch® Ultra®2 BGMS versus standard BGMS during 52 weeks of use.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- OneTouch® Ultra®2 System, Standard care
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OneTouch® Ultra®2 SystemBehavioural
Education and self-monitoring of blood glucose performed with OneTouch® Ultra®2 System that includes the Simple Start™ home-based education program
Standard careBehavioural
Standard education and self-monitoring of blood glucose performed with traditional meter systems
| Study group | Role | What they receive |
|---|---|---|
| OneTouch® Ultra®2 system | Experimental | Test care group assigned to OneTouch® Ultra®2 system Receives: Behavioral: OneTouch® Ultra®2 System |
| Standard care | Active comparator | Control group receiving standard care with a traditional blood glucose monitoring system Receives: Behavioral: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in A1C From Baseline to Week 52 Between the OneTouch® Ultra®2 and Control BGMS.
Measured: From baseline to 52 wks
Secondary outcomes (1)
Change in Daily Glycemic Excursions Between the OneTouch® Ultra®2 and Control BGMS.
Measured: 52 wks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2006 (estimated)
- Study start1 Oct 2006
- Primary completion1 Jan 2009
- Study completion1 Jan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- LifeScan
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Synexus(UK), CPS(UK), Battelle CRO(US), RPS CRO(US), Robertson Centre For Biostatistics (UK)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00401622
- Sponsor's protocol ID
- CR-1039797
- Status last verified
- May 2019
- First submitted
- 16 Nov 2006
- Last updated
- 15 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Benefits of a Blood Glucose Monitoring System in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00401622
- Acronym / sponsor ID
- CR-1039797
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- LifeScanIndustry (pharma, biotech, devices)
- Collaborators
- Synexus(UK), CPS(UK), Battelle CRO(US), RPS CRO(US), Robertson Centre For Biostatistics (UK)
- Study start
- 1 Oct 2006 (actual)
- Primary completion
- 1 Jan 2009 (actual)
- Study completion
- 1 Jan 2009 (actual)
- First posted
- 20 Nov 2006 (estimated)
- Results
- Posted 16 Sep 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Clinical benefits of the OneTouch® Ultra®2 BGMS versus standard BGMS during 52 weeks of use.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OneTouch® Ultra®2 system | Experimental | Behavioral: OneTouch® Ultra®2 SystemTest care group assigned to OneTouch® Ultra®2 system |
| Standard care | Active comparator | Behavioral: Standard careControl group receiving standard care with a traditional blood glucose monitoring system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Current diagnosis of type 2 diabetes
- Diagnosed at least 3 months prior to the start of the study but not more than 15 years from the start of the study
- Stable regimen (i.e., no changes in therapeutic regimen) for the past three months
- Baseline HbA1c of 7.0 to 8.9%, inclusive
Key exclusion criteria (4 listed)
- Using insulin
- Using oral agents that target post-prandial hyperglycemia (Note: These medications may be added during the study)
- Known history of anemia or disorders associated with anemia
- Has previously used the devices being tested in the study
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 |
|---|---|---|
| OneTouch® Ultra®2 SystemEducation and self-monitoring of blood glucose performed with OneTouch® Ultra®2 System that includes the Simple Start™ home-based education program | Behavioural | OneTouch® Ultra®2 system |
| Standard careStandard education and self-monitoring of blood glucose performed with traditional meter systems | Behavioural | Standard care |
Primary outcome
Change in A1C From Baseline to Week 52 Between the OneTouch® Ultra®2 and Control BGMS.
Time frame: From baseline to 52 wks
1 secondary outcome
Change in Daily Glycemic Excursions Between the OneTouch® Ultra®2 and Control BGMS.
Time frame: 52 wks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OneTouch® Ultra®2 System in people with Diabetes Mellitus, Type 2, run by LifeScan at 18 sites in 3 countries.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 15 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, United Kingdom, Canada. 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?
Yes. Results are posted in the registry (first posted 16 Sep 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in A1C From Baseline to Week 52 Between the OneTouch® Ultra®2 and Control BGMS. (time frame: From baseline to 52 wks). 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 15 May 2019.