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

NCT ID: NCT01588106

Last Updated: 2017-03-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 154 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2016-01-31

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.

Conditions

Diabetes Mellitus Type 2

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Test group

patients using CONTOUR Next USB

No interventions assigned to this group

Control group

patients using standard CONTOUR

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: collaborator

GWT-TUD GmbH

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Schwarz, Prof

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Carl Gustav Carus

Locations

Diabetespraxis Prenzlauer Allee

Berlin, , Germany

Praxis Dr. Fießelmann

Berlin, , Germany

Praxis Dr. Stephan

Berlin, , Germany

Gemeinschaftspraxis Lorra/Bonnermann

Bochum, , Germany

Praxis Dr. Holderied

Brand-Erbisdorf, , Germany

Spreewaldklinik

Burg, , Germany

Diabeteszentrum DO

Dortmund, , Germany

Studienzentrum Prof. Hanefeld

Dresden, , Germany

Universitätsklinikum Dresden, Medizinische Klinik III

Dresden, , Germany

Gemeinschaftspraxis Schaden

Düsseldorf, , Germany

Praxis Dr. Stier

Freital, , Germany

SMO.MD GmbH

Magdeburg, , Germany

Praxis Dr. Ruhland

München, , Germany

Metabolicum

München, , Germany

Praxis Dr. Engelmayer

München, , Germany

Diabeteszentrum Oschatz

Oschatz, , Germany

Countries

Germany

Other Identifiers

GWT-2011-1

Identifier Type: -

Identifier Source: org_study_id