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

Sponsors

Lead sponsor: Profil Institut für Stoffwechselforschung GmbH

Collaborator: Sanofi

Source Profil Institut für Stoffwechselforschung GmbH
Brief Summary

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.

Overall Status Completed
Start Date November 2012
Primary Completion Date January 2014
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
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 6 hours
Enrollment 20
Condition
Intervention

Intervention type: Other

Intervention name: Comparison of different Blood Glucose Meters

Arm group label: BGStar

Eligibility

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, -

Gender: All

Minimum age: 18 Years

Maximum age: 74 Years

Healthy volunteers: No

Location
facility Profil Institut für Stoffwechselforschung GmbH
Location Countries

Germany

Verification Date

November 2012

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Number Of Arms 1
Arm Group

Arm group label: BGStar

Arm group type: Other

Description: Comparision

Study Design Info

Allocation: Non-Randomized

Intervention model: Factorial Assignment

Masking: None (Open Label)

Source: ClinicalTrials.gov