Evaluation of CONTOUR® USB BGMS on Glycaemic Control in Insulin-treated Diabetic Patients (CONGO)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by GWT-TUD GmbH
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
GWT-TUD GmbH
ClinicalTrials.gov Identifier:
NCT01588106
First received: April 26, 2012
Last updated: February 10, 2014
Last verified: February 2014
  Purpose

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.


Condition
Diabetes Mellitus Type 2

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by GWT-TUD GmbH:

Primary Outcome Measures:
  • reduction in HbA1c [ Time Frame: baseline, after 9 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 240
Study Start Date: June 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Test group
patients using CONTOUR Next USB
Control group
patients using standard CONTOUR

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

patients of assorted practices

Criteria

Inclusion Criteria:

  • 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.
    • 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

Exclusion Criteria:

  • 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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01588106

Contacts
Contact: Antje Gasparic, PhD +49 351 25933 ext 189 antje.gasparic@gwtonline.de
Contact: Carsta Köhler, PhD +49 351 25933 ext 190 koehler@gwtonline.de

Locations
Germany
Praxis Dr. Ruthe Recruiting
Berlin, Germany, 10437
Contact: Ursula Ruthe, Dr    +49 30 44342889      
Principal Investigator: Ursula Ruthe, Dr         
Praxis Dr. Fießelmann Recruiting
Berlin, Germany, 13597
Contact: Albrecht Fießelmann, Dr    +49 303336070      
Principal Investigator: Albrecht Fießelmann, Dr         
Diabetespraxis Prenzlauer Allee Recruiting
Berlin, Germany, 10409
Contact: Hermann Braun, Dr    +49 3044716031      
Principal Investigator: Hermann Braun, Dr         
Gemeinschaftspraxis Lorra/Bonnermann Recruiting
Bochum, Germany, 44869
Contact: Babette Lorra, Dr    +49 2327 76188      
Principal Investigator: Babette Lorra, Dr         
Praxis Dr. Holderied Recruiting
Brand-Erbisdorf, Germany, 09618
Contact: Sylke Holderied, Dr    +49 37322 2427      
Principal Investigator: Sylke Holderied, Dr         
Spreewaldklinik Recruiting
Burg, Germany, 03096
Contact: Wolfram Kamke, Dr    +49 35603 63155      
Principal Investigator: Wolfram Kamke, Dr         
Praxis Dr. Preuss Recruiting
Datteln, Germany, 45711
Contact: Uwe Preuss, Dr    +49 2363 56751 00      
Principal Investigator: Uwe Preuss, Dr         
Diabeteszentrum DO Recruiting
Dortmund, Germany, 44137
Contact: Klaus Busch, Dr    +49 231 9143270      
Principal Investigator: Klaus Busch, Dr         
Universitätsklinikum Dresden, Medizinische Klinik III Recruiting
Dresden, Germany, 01307
Contact: Sabine Fischer, PD Dr    +49 351 25933 ext 261      
Principal Investigator: Sabine Fischer, PD Dr         
Studienzentrum Prof. Hanefeld Recruiting
Dresden, Germany, 01307
Contact: Wilgard Pohl, Dr    +49 351 44005 ext 80      
Principal Investigator: Wilgard Pohl, Dr         
Gemeinschaftspraxis Schaden Recruiting
Düsseldorf, Germany, 40211
Contact: Urs Schaden, Dr         
Principal Investigator: Urs Schaden, Dr         
Praxis Dr. Esser Recruiting
Essen-Kettwig, Germany, 45219
Contact: Michael Esser, Dr    +49 2054 955620      
Principal Investigator: Michael Esser, Dr         
Praxis Dr. Stier Recruiting
Freital, Germany, 01705
Contact: Ulf Stier, Dr    +49 351 6491305      
Principal Investigator: Ulf Stier, Dr         
Gemeinschaftspraxis Kugler&Hiemer Recruiting
Köln, Germany, 50858
Contact: Michael Hiemer, Dr    +49 2234 75110      
Principal Investigator: Michael Hiemer, Dr         
SMO.MD GmbH Recruiting
Magdeburg, Germany, 39112
Contact: Jana Heider    +49 391 6119517      
Principal Investigator: Gabriele Illies         
Metabolicum Recruiting
München, Germany, 80687
Contact: Stephan Lederer, PD Dr    +49 89 51739980      
Principal Investigator: Stephan Lederer, PD Dr         
Praxis Dr. Ruhland Recruiting
München, Germany, 80331
Contact: Bernd Ruhland, Dr    +49 89 280634      
Principal Investigator: Bernd Ruhland, Dr         
Praxis Dr. Engelmayer Recruiting
München, Germany, 81241
Contact: Dorothea Engelmayer, Dr    +49 89 5707255      
Principal Investigator: Dorothea Engelmayer, Dr         
Praxis Dr. Bögel Recruiting
Nürnberg, Germany, 90471
Contact: Michael Bögel, Dr    +49 911 12035712      
Principal Investigator: Michael Bögel, Dr         
Diabeteszentrum Oschatz Completed
Oschatz, Germany, 04758
Sponsors and Collaborators
GWT-TUD GmbH
Bayer
Investigators
Principal Investigator: Peter Schwarz, Prof Universitätsklinikum Carl Gustav Carus
  More Information

No publications provided

Responsible Party: GWT-TUD GmbH
ClinicalTrials.gov Identifier: NCT01588106     History of Changes
Other Study ID Numbers: GWT-2011-1
Study First Received: April 26, 2012
Last Updated: February 10, 2014
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 30, 2014