NCT03737188

Brief Summary

Assessment of the system accuracy of different blood glucose monitoring systems available in Europe

Trial Health

87
On Track

Trial Health Score

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

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable diabetes

Timeline
Completed

Started Nov 2018

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

First Submitted

Initial submission to the registry

October 5, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 9, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

November 14, 2018

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2018

Completed
Last Updated

February 26, 2019

Status Verified

February 1, 2019

Enrollment Period

21 days

First QC Date

October 5, 2018

Last Update Submit

February 25, 2019

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

  • Analysis of system accuracy based on ISO 15197

    Assessment of the analytical measurement performance of 18 blood glucose montoring systems based on procedures defined in ISO 15197

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

Interventions

Blood glucose monitoring systems for self-testingDEVICE

Capillary blood samples will be used for the evaluation of system accuracy.

Also known as: 18 BGMS from 18 different manufacturers: ABRA, Accu-Chek Guide, AURUM Blutzucker-Messsystem, CareSens Dual, CERA-CHEK 1 Code, Contour next ONE, eBsensor, FreeStyle Freedom Lite, GL 50 (evo), GlucoCheck GOLD, GlucoMen areo 2K, GluNEO, MyStar DoseCoach, OneTouch Verio Flex, Pic GlucoTest, Rightest GM700S, TRUEyou Blutzuckermesssystem, WaveSense JAZZ WIRELESS

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 subjects without diabetes
  • Signed informed consent form
  • Minimum age of 18 years
  • ubjects are legally competent and capable to understand character, meaning and consequences of the study.
  • If blood glucose values \< 80 mg/dl or \> 300 mg/dl shall be measured after short term alteration in insulin therapy:
  • Male or female with type 1 diabetes and intensified insulin therapy or insulin pump therapy.
  • Signature of subjects to document consent with these procedures on informed consent form.

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)
  • Current constitution that compromises the subject's capability to participate in the study (at the study physician's discretion)
  • Being unable to give informed consent
  • \< 18 years
  • Legally incompetent
  • Being committed to an institution (e.g. psychiatric clinic)
  • Language barriers potentially compromising an adequate compliance with study procedures
  • Dependent on investigator or sponsor
  • If blood glucose values \< 80 mg/dl shall be measured after short term alteration in insulin therapy, subjects with type 1 diabetes, suffering from:
  • Coronary heart disease
  • Condition after myocardial infarction
  • Condition after cerebral events
  • 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 an der Universität Ulm

Ulm, 89081, Germany

Location

Related Publications (1)

  • Pleus S, Baumstark A, Jendrike N, Mende J, Link M, Zschornack E, Haug C, Freckmann G. System accuracy evaluation of 18 CE-marked current-generation blood glucose monitoring systems based on EN ISO 15197:2015. BMJ Open Diabetes Res Care. 2020 Jan;8(1):e001067. doi: 10.1136/bmjdrc-2019-001067.

    PMID: 31958308DERIVED

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
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2018

First Posted

November 9, 2018

Study Start

November 14, 2018

Primary Completion

December 5, 2018

Study Completion

December 5, 2018

Last Updated

February 26, 2019

Record last verified: 2019-02

Locations

DE(1)