Project BLOOM Regulatory Clinical Evaluation - System Accuracy, User Performance and System Use Evaluation

L

LifeScan

Status

Completed

Conditions

Diabetes Mellitus

Treatments

Device: Blood Glucose Monitoring System.

Study type

Interventional

Funder types

Industry

Identifiers

NCT02767336
3141352 and 3141353

Details and patient eligibility

About

Clinical Evaluation including System Accuracy, User Performance, System Use, Instructions for Use and Marketing Claims Evaluation.

Enrollment

174 patients

Sex

All

Ages

6+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Summary of Inclusion Criteria:

  • Able to voluntarily provide written informed consent to participate in the study.
  • User Performance Accuracy Testing Only: Self-Monitoring - Subject is currently performing unassisted self-monitoring of blood glucose.
  • For subjects participating in the In Vivo Glucose adjustment procedure age range is 18 - 45.

Summary of Exclusion Criteria:

  • Female subjects who are pregnant or lactating.
  • Subjects who, in the opinion of the Investigator, are unsuitable for participation in the study.
  • User Performance Accuracy Testing Only -Prior involvement with the investigational BGMS being used in this study.

Trial design

174 participants in 1 patient group

Blood Glucose monitoring System (BGMS)
Experimental group
Description:
Intervention: Blood Glucose monitoring System (BGMS) Results obtained from the BGMS for UP and SA are compared to a reference instrument (YSI)
Treatment:
Device: Blood Glucose Monitoring System.

Trial contacts and locations

4

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems