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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01588106
Recruitment Status : Completed
First Posted : April 30, 2012
Results First Posted : March 9, 2017
Last Update Posted : March 9, 2017
Information provided by (Responsible Party):

Brief 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.

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 or disease
Diabetes Mellitus Type 2

Study Type : Observational
Actual Enrollment : 154 participants
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
Study Start Date : June 2012
Actual Primary Completion Date : October 2015
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

Test group
patients using CONTOUR Next USB
Control group
patients using standard CONTOUR

Primary Outcome Measures :
  1. Reduction in HbA1c [ Time Frame: Baseline, after 9 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients of assorted practices

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01588106

Diabetespraxis Prenzlauer Allee
Berlin, Germany, 10409
Praxis Dr. Fießelmann
Berlin, Germany, 13597
Praxis Dr. Stephan
Berlin, Germany, 13597
Gemeinschaftspraxis Lorra/Bonnermann
Bochum, Germany, 44869
Praxis Dr. Holderied
Brand-Erbisdorf, Germany, 09618
Burg, Germany, 03096
Diabeteszentrum DO
Dortmund, Germany, 44137
Studienzentrum Prof. Hanefeld
Dresden, Germany, 01307
Universitätsklinikum Dresden, Medizinische Klinik III
Dresden, Germany, 01307
Gemeinschaftspraxis Schaden
Düsseldorf, Germany, 40211
Praxis Dr. Stier
Freital, Germany, 01705
Magdeburg, Germany, 39112
Praxis Dr. Ruhland
München, Germany, 80331
München, Germany, 80687
Praxis Dr. Engelmayer
München, Germany, 81241
Diabeteszentrum Oschatz
Oschatz, Germany, 04758
Sponsors and Collaborators
Principal Investigator: Peter Schwarz, Prof Universitätsklinikum Carl Gustav Carus

Responsible Party: GWT-TUD GmbH Identifier: NCT01588106     History of Changes
Other Study ID Numbers: GWT-2011-1
First Posted: April 30, 2012    Key Record Dates
Results First Posted: March 9, 2017
Last Update Posted: March 9, 2017
Last Verified: January 2016

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