NCT02358408

Brief Summary

The study consists of 2 parts: The objective of part 1 of this study is the performance of a short evaluation of system accuracy for 25 subjects in order to familiarize the study personnel with the study BGMS to be used during the planned evaluation of system accuracy (see IDT-1416-BL (Part 2)), ensure that the Karajishi meters are fully functioning, assure and document the accuracy of the comparison method, evaluate and validate the processes and procedures of the study methodology. The objective of part 2 of this study is the evaluation of system accuracy following ISO 15197:2013 (E), clause 6.3 in which accuracy requirements and applicable test procedures for blood glucose monitoring systems intended for self-monitoring of blood glucose by patients are stipulated. This study will be performed for Karajishi Contour and Karajishi Contour TS (manufacturer: Bayer Healthcare Diabetes Care) with 3 reagent system lots for each BGMS.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P50-P75 for not_applicable diabetes

Timeline
Completed

Started Jan 2015

Shorter than P25 for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

January 26, 2015

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 9, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

January 28, 2016

Status Verified

January 1, 2016

Enrollment Period

1 month

First QC Date

January 26, 2015

Last Update Submit

January 27, 2016

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

  • Evaluation of System Accuracy according to ISO 15197 (see description)

    System accuracy criteria: 1. Following ISO 15197:2013 (E), the BGMS shall meet both of the following criteria: * Criterion A: 95 % of the measured glucose values shall fall within either ± 15 mg/dl (0.83 mmol/l) of the average comparison measurement result at glucose concentrations \< 100 mg/dl (5.55 mmol/l) or within ± 15 % at glucose concentrations ≥ 100 mg/dl (5.55 mmol/l). * Each lot shall pass acceptability criterion A. * Criterion B: 99 % of individual glucose measured values shall fall within zones A and B of the Consensus Error Grid (CEG) for type 1 diabetes. 2. Applying ISO 15197:2003 accuracy criteria: * 95 % of the measured glucose values shall fall within either ± 15 mg/dl (0.83 mmol/l) of the average comparison measurement result at glucose concentrations \< 75 mg/dl (4.2 mmol/l) or within ± 20 % at glucose concentrations ≥ 75 mg/dl (4.2 mmol/l).

    For each subject, the experimental phase has an expected duration of up to 6 hours

Interventions

Blood glucose monitoring systems for self-testingDEVICE
Also known as: Karajishi Contour, Karajishi Contour TS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female, with type 1 diabetes, type 2 diabetes or no diabetes
  • For provoked blood glucose excursions due to insulin dose adjustment: Male or female with type 1 diabetes or type 2 diabetes and intensified insulin therapy or insulin pump therapy.
  • Minimum age of 18 years
  • Signed informed consent form
  • Legally competent and capable to understand character, meaning and consequences of the study

You may not qualify if:

  • Pregnancy or lactation period
  • Severe acute disease (at the study physician's discretion)
  • Severe chronic disease with potential risk during the test procedures (at the study physician's discretion)
  • Physical or mental constitution that compromises the subject's capability to participate in the study (at the study physician's discretion)
  • Incapability of giving informed consent
  • \< 18 years
  • Legally incompetent
  • Accommodated in an institution (e.g. psychiatric clinic)
  • Language barriers potentially compromising an adequate compliance with study procedures
  • Dependent from investigator or sponsor
  • For provoked blood glucose excursions 50 - 80 mg/dl:
  • Coronary heart disease
  • Condition after myocardial infarction
  • Cerebral incidence
  • Peripheral arterial occlusive disease
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm

Ulm, 89081, Germany

Location

Related Publications (1)

  • Pleus S, Baumstark A, Rittmeyer D, Jendrike N, Haug C, Freckmann G. Performance of two updated blood glucose monitoring systems: an evaluation following ISO 15197:2013. Curr Med Res Opin. 2016 May;32(5):847-55. doi: 10.1185/03007995.2016.1146666. Epub 2016 Feb 23.

    PMID: 26809001BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Self-Testing

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Self CareTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2015

First Posted

February 9, 2015

Study Start

January 1, 2015

Primary Completion

February 1, 2015

Study Completion

April 1, 2015

Last Updated

January 28, 2016

Record last verified: 2016-01

Locations

DE(1)