Clinical trial NCT01588106: Evaluation of CONTOUR® USB BGMS on Glycaemic Control in Insulin-treated Diabetic Patients
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus Type 2
Lead sponsor: GWT-TUD GmbH
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2012-04-30
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients of assorted practices

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.


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

Primary outcomes:
measure: Reduction in HbA1c
timeFrame: Baseline, after 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Diabetespraxis Prenzlauer Allee
city: Berlin
country: Germany
facility: Praxis Dr. Fießelmann
city: Berlin
country: Germany
facility: Praxis Dr. Stephan
city: Bochum
country: Germany
facility: Gemeinschaftspraxis Lorra/Bonnermann
city: Brand-Erbisdorf
country: Germany
facility: Praxis Dr. Holderied
city: Burg
country: Germany
facility: Spreewaldklinik
city: Dortmund
country: Germany
facility: Diabeteszentrum DO
city: Dresden
country: Germany
facility: Studienzentrum Prof. Hanefeld
city: Dresden
country: Germany
facility: Universitätsklinikum Dresden, Medizinische Klinik III
city: Düsseldorf
country: Germany
facility: Gemeinschaftspraxis Schaden
city: Freital
country: Germany
facility: Praxis Dr. Stier
city: Magdeburg
country: Germany
facility: SMO.MD GmbH
city: München
country: Germany
facility: Praxis Dr. Ruhland
city: München
country: Germany
facility: Metabolicum
city: München
country: Germany
facility: Praxis Dr. Engelmayer
city: Oschatz
country: Germany
facility: Diabeteszentrum Oschatz
Study officials:
affiliation: Universitätsklinikum Carl Gustav Carus
name: Peter Schwarz, Prof
role: PRINCIPAL_INVESTIGATOR
References: