Diabetes Mellitus Type 2CONGONCT01588106
Evaluation of CONTOUR® USB BGMS on Glycaemic Control in Insulin-treated Diabetic Patients
An observational study of Diabetes Mellitus Type 2, run by GWT-TUD GmbH at 16 sites in Germany.
Trial summary
The purpose of this study is to evaluate if the use of the CONTOUR Next USB BGMS system with AutoLog and Trends features and integrated data management software (Glucofacts ™ DELUXE) enables behavioral changes that may lead to improvement in glycemic control, expressed as a reduction in HbA1c as primary endpoint. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus Type 2
- How many people
- 154 participants
- Where
- 16 sitesGermany
- Study dates
- Jun 2012to Jan 2016
- Phase
- Observational
- 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
Study population: patients of assorted practices
Who may be able to join
- Type 2 diabetes
- Therapy with insulin only (ICT) or ICT in combination with Metformin
- HbA1c at baseline > 7.5% and < 11%
- Patients at least 18 years of age
- Patients willing to complete all study visits and study procedures including:
- Testing their BG at least 3 times a day during the entire study.
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- Using the paper logbook provided (control group)
- Using the Auto log meal-marker + reminder feature in CONTOUR Next USB regularly (TEST subjects only)
- Using the Trends feature in CONTOUR Next USB regularly (TEST subjects only)
- Uploading the CONTOUR Next USB meter to personal computer (subject must have personal computer at home or access to a computer - see system requirements in appendix for technical details).
- Patients who are able to speak, read and understand German
- Patients who are currently performing self-testing of blood glucose at home routinely (at least 3 times per day) for 4 weeks or more
- Patients who are currently adjusting there insulin dosages themselves based on the self-testing of blood glucose at home
- Written informed consent at beginning of the study
Who cannot join
- Patients who have been using CONTOUR Next USB meter regularly during the previous 12 months
- Patients treated with oral antidiabetic drugs except for Metformin; or diet alone
- Change of diabetes therapy within the last 3 months
- Change of HbA1c level of more than ±0.5% within the last 3 months
- Patients who are using a continuous blood glucose measurement system regularly
- Patients with home health aides who assist with their BG testing and /or insulin adjustment
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- Patients with macroalbuminuria
- Steroid therapy within the last 3 months. Topic or inhalative use is no exclusion criterion when not used regularly (more than 5 times a week).
- Uncontrolled blood pressure ≥ 170/100 at screening
- BMI > 40 kg/m²
- Anemia according to WHO-definition (hemoglobin < 13 g/100 ml [male] or < 12 g/100 ml [female])
- Creatinin > 150 µmol/l and/or GFR < 50 mmol/min/ 1.73m² (measured within the last 3 months before screening)
- Operation with inpatient stay planned during the study
- Current pregnancy or pregnancy planned during the study; or breastfeeding women.
- Women with childbearing potential who are not practicing an acceptable method of birth control. Acceptable methods of birth control include tubal ligation, transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, sexual abstinence, double barrier method and vasectomized partner
- Alcohol or drug abuse within the last 3 months
- Patients with the following impairments which, in the opinion of the investigator, would seriously compromise the integrity of the study:
- Significant visual impairment
- Significant hearing impairment
- Cognitive disorder
- Significant unstable co-morbidity (with notable change within the past 3 months)
- Severe renal disease, disease with a strong impact on life expectancy
- Inability to have or use and computer
- Inability to use a meter correctly
- Any other condition as per investigator's discretion
- Current participation in another clinical study. Participation in another trial within 6 weeks before screening.
- Employees of Bayer Vital Diabetes Care, the GWT or the University of Dresden
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
Germany16 sites
Diabetespraxis Prenzlauer Allee
Berlin, 10409
Praxis Dr. Fießelmann
Berlin, 13597
Praxis Dr. Stephan
Berlin, 13597
Gemeinschaftspraxis Lorra/Bonnermann
Bochum, 44869
Praxis Dr. Holderied
Brand-Erbisdorf, 09618
Spreewaldklinik
Burg, 03096
Diabeteszentrum DO
Dortmund, 44137
Studienzentrum Prof. Hanefeld
Dresden, 01307
Universitätsklinikum Dresden, Medizinische Klinik III
Dresden, 01307
Gemeinschaftspraxis Schaden
Düsseldorf, 40211
Praxis Dr. Stier
Freital, 01705
SMO.MD GmbH
Magdeburg, 39112
Praxis Dr. Ruhland
München, 80331
Metabolicum
München, 80687
Praxis Dr. Engelmayer
München, 81241
Diabeteszentrum Oschatz
Oschatz, 04758
About this study
Official title: Evaluation of the Impact of the CONTOUR® USB Blood Glucose Monitoring System With Integrated Data Management on Glycaemic Control in Insulin-treated Diabetic Patients
The purpose of this study is to evaluate if the use of the CONTOUR Next USB BGMS system with AutoLog and Trends features and integrated data management software (Glucofacts ™ DELUXE) enables behavioral changes that may lead to improvement in glycemic control, expressed as a reduction in HbA1c as primary endpoint.
Patients will be randomized either to using CONTOUR Next USB or CONTOUR. Patients will be trained in using the devices and return every 3 months until month 9 after baseline.
- Conditions
- Diabetes Mellitus Type 2
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Test group | patients using CONTOUR Next USB | |
| Control group | patients using standard CONTOUR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in HbA1c
Measured: Baseline, after 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2012 (estimated)
- Study startJun 2012
- Primary completionOct 2015
- Study completionJan 2016
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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- GWT-TUD GmbH
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor
- Investigators
- Peter Schwarz, Prof, Principal investigator, Universitätsklinikum Carl Gustav Carus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01588106
- Sponsor's protocol ID
- GWT-2011-1
- Acronym
- CONGO
- Status last verified
- Jan 2016
- First submitted
- 26 Apr 2012
- Last updated
- 9 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of the CONTOUR® USB Blood Glucose Monitoring System With Integrated Data Management on Glycaemic Control in Insulin-treated Diabetic Patients
- ClinicalTrials.gov ID
- NCT01588106
- Acronym / sponsor ID
- CONGO / GWT-2011-1
- Conditions
- Diabetes Mellitus Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- GWT-TUD GmbHUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- Jun 2012
- Primary completion
- Oct 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 30 Apr 2012 (estimated)
- Results
- Posted 9 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate if the use of the CONTOUR Next USB BGMS system with AutoLog and Trends features and integrated data management software (Glucofacts ™ DELUXE) enables behavioral changes that may lead to improvement in glycemic control, expressed as a reduction in HbA1c as primary endpoint.
Patients will be randomized either to using CONTOUR Next USB or CONTOUR. Patients will be trained in using the devices and return every 3 months until month 9 after baseline.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | – | –patients using CONTOUR Next USB |
| Control group | – | –patients using standard CONTOUR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients of assorted practices
Key inclusion criteria (14 listed)
- Type 2 diabetes
- Therapy with insulin only (ICT) or ICT in combination with Metformin
- HbA1c at baseline > 7.5% and < 11%
- Patients at least 18 years of age
- Patients willing to complete all study visits and study procedures including:
Key exclusion criteria (27 listed)
- Patients who have been using CONTOUR Next USB meter regularly during the previous 12 months
- Patients treated with oral antidiabetic drugs except for Metformin; or diet alone
- Change of diabetes therapy within the last 3 months
- Change of HbA1c level of more than ±0.5% within the last 3 months
- Patients who are using a continuous blood glucose measurement system regularly
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Reduction in HbA1c
Time frame: Baseline, after 9 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Peter Schwarz, Prof principal investigator
Universitätsklinikum Carl Gustav Carus
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus Type 2, run by GWT-TUD GmbH at 16 sites in Germany.
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 14 inclusion and 27 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 9 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Germany. 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 9 Mar 2017). 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?
Reduction in HbA1c (time frame: Baseline, after 9 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 9 Mar 2017.