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A Trial Investigating the Accuracy and Precision of the BGStar® and iBGStar® Blood Glucose Meter in Subjects With Type 1 Diabetes

This study is not yet open for participant recruitment.
Verified November 2012 by Profil Institut für Stoffwechselforschung GmbH
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Profil Institut für Stoffwechselforschung GmbH
ClinicalTrials.gov Identifier:
NCT01730885
First received: November 15, 2012
Last updated: November 21, 2012
Last verified: November 2012
History of Changes
  Purpose

Due to continuing technological progress and better understanding of the needs for glucose monitoring, the performance requirements of blood glucose meters, primarily regarding their accuracy, are constantly debated and keep evolving as a consequence. Recently a discussion was initiated by the Food and Drug Administration (FDA) to improve the accuracy of BG meters in the point-of-care testing setting by asking for fulfilment of higher requirements.


Condition Intervention Phase
Diabetes Mellitus
 Other: Comparison of different Blood Glucose Meters
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: Open Label

Resource links provided by NLM:

Drug Information available for: Dextrose
U.S. FDA Resources

Further study details as provided by Profil Institut für Stoffwechselforschung GmbH:

Primary Outcome Measures:
  • Mean absolute relative deviation (MARD) from paired reference values of BGStar®, iBGStar® and comparator BG meter measurements at stable hypoglycaemic, euglycaemic and hyperglycaemic levels and overal [ Time Frame: 6 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: November 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
BGStar
Comparision
 Other: Comparison of different Blood Glucose Meters

  Eligibility

Ages Eligible for Study:   18 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed and dated informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
  2. Male or female subjects aged 18-74 years (both inclusive).
  3. Type 1 diabetes mellitus (as diagnosed clinically) ≥ 12 months.
  4. Body mass index 18.0-28.0 kg/m2 (both inclusive).
  5. HbA1c ≤ 9.0 % by local laboratory analysis.

Exclusion Criteria:

  1. Known or suspected hypersensitivity to lancet fingerpricks / needle injections.
  2. Previous participation in this trial. Participation is defined as having performed at least one BG meter measurement as part of the study.
  3. Receipt of any investigational medicinal product within 30 days before randomisation in this trial.
  4. Formation of callus on the fingertips or any other skin condition that may hamper fingerprick blood sampling and/or insufficient capillary blood volume sampling (< 50 μL) during test fingerprick(s).
  5. Haemoglobin < 8.0 mmol/L (male) or < 6.4 mmol/L (female), total leukocyte count < 3.0 x 109/L, thrombocytes <100 x 109/L, serum creatinine levels ≥ 126 μmol/L (male) or ≥ 111 μmol/L (female), bilirubin > 3x the upper limit of normal (ULN), and alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) and gamma-glutamyl transferase (γ-GT) > 2 x ULN.
  6. Suffer from or history of a life threatening disease (i.e. cancer except basal cell skin cancer or squamous cell skin cancer), or any clinically significant respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological (with the exception of diabetes mellitus and euthyroid struma), haematological, dermatological, venereal, -
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01730885

Contacts
Contact: Christoph Kapitza, MD +4921314018 ext 100 christoph.kapitza@profil.com

Locations
Germany
Profil Institut für Stoffwechselforschung GmbH Not yet recruiting
Neuss, NRW, Germany, 41460
Contact: Christoph Kapitza, MD     +4921314018 ext 100     christoph.kapitza@profil.com    
Sponsors and Collaborators
Profil Institut für Stoffwechselforschung GmbH
Sanofi
  More Information

No publications provided

Responsible Party: Profil Institut für Stoffwechselforschung GmbH
ClinicalTrials.gov Identifier: NCT01730885     History of Changes
Other Study ID Numbers: BGStar
Study First Received: November 15, 2012
Last Updated: November 21, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on May 16, 2013