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

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Profil Institut für Stoffwechselforschung GmbH
ClinicalTrials.gov Identifier:
NCT01730885
First received: November 15, 2012
Last updated: February 4, 2014
Last verified: November 2012

November 15, 2012
February 4, 2014
November 2012
January 2014   (final data collection date for primary outcome measure)
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 ]
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Complete list of historical versions of study NCT01730885 on ClinicalTrials.gov Archive Site
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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
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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.

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Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Diabetes Mellitus
Other: Comparison of different Blood Glucose Meters
BGStar
Comparision
Intervention: Other: Comparison of different Blood Glucose Meters
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
Not Provided
January 2014   (final data collection date for primary outcome measure)

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, -
Both
18 Years to 74 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01730885
BGStar
No
Profil Institut für Stoffwechselforschung GmbH
Profil Institut für Stoffwechselforschung GmbH
Sanofi
Not Provided
Profil Institut für Stoffwechselforschung GmbH
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP