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

NCT01730885 | Completed Phase 4

• 1 other identifier: BGStar
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

BGStar

OTHER

Comparision

Other: Comparison of different Blood Glucose Meters

Interventions

Comparison of different Blood Glucose Meters OTHER

BGStar

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Male or female subjects aged 18-74 years (both inclusive).
• Type 1 diabetes mellitus (as diagnosed clinically) ≥ 12 months.
• Body mass index 18.0-28.0 kg/m2 (both inclusive).
• HbA1c ≤ 9.0 % by local laboratory analysis.

You may not qualify if:

• Known or suspected hypersensitivity to lancet fingerpricks / needle injections.
• Previous participation in this trial. Participation is defined as having performed at least one BG meter measurement as part of the study.
• Receipt of any investigational medicinal product within 30 days before randomisation in this trial.
• 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).
• 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.
• 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, -

Sponsors & Collaborators

• Profil Institut für Stoffwechselforschung GmbH: lead
• Sanofi: collaborator

Study Sites (1)

Profil Institut für Stoffwechselforschung GmbH

Neuss, North Rhine-Westphalia, 41460, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2012
• First Posted: November 21, 2012
• Study Start: November 1, 2012
• Primary Completion: January 1, 2014
• Last Updated: February 5, 2014

Record last verified: 2012-11

Locations

DE (1)