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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Other: Comparison of different Blood Glucose Meters

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • NRW
    • Neuss, NRW, Germany, 41460
      • Profil Institut für Stoffwechselforschung GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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, -

Study Plan

How is the study designed?

Design Details

• Allocation: Non-Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: BGStar; Comparision	Other: Comparison of different Blood Glucose Meters

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Profil Institut für Stoffwechselforschung GmbH
• Collaborators: Sanofi

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: November 15, 2012
• First Submitted That Met QC Criteria: November 15, 2012
• First Posted (Estimate): November 21, 2012

Study Record Updates

• Last Update Posted (Estimate): February 5, 2014
• Last Update Submitted That Met QC Criteria: February 4, 2014
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: BGStar