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OpenTrials
Completed

NCT Number: NCT03433573

Paediatric Use of the Abbott Sensor Based Glucose Monitoring System

Accuracy evaluation of the Abbott Sensor Based Glucose Monitoring System when used by children with diabetes.

Completed

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Key information

Age range

4 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 4-17 years (inclusive).
  • Have type 1 or type 2 diabetes using insulin administered by injections or continuous subcutaneous insulin infusion (CSII).
  • Currently testing blood glucose levels at least twice per day.
  • Each participant has an identified Caregiver aged ≥18 years.
  • In the investigator's opinion, technically capable of using device (participant and/or caregiver).

Exclusion criteria

  • Concomitant disease or condition that may compromise patient safety including and not limited to; cystic fibrosis, severe mental illness, known or suspected eating disorder or any uncontrolled long term medical condition.
  • Currently prescribed oral steroid therapy for any acute or chronic condition.
  • Currently receiving dialysis treatment or planning to receive dialysis during the study.
  • Female participant known to be pregnant.
  • Participating in another study of a glucose monitoring device or drug that could affect glucose measurements or management.
  • Currently using a real-time or professional use continuous glucose monitoring (CGM) or FreeStyle Libre device or is planning to use one during the study, and unwilling to stop use of the device during the study.
  • Known (or suspected) allergy to medical grade adhesives.
  • In the investigator's opinion the participant or caregiver is unsuitable to participate due to any other cause/reason (both patient and caregiver considered).

Treatment and study plan

Abbott Sensor Based Glucose Monitoring System

Device

Subjects will wear the Abbott Sensor Based Glucose Monitoring System and will be asked to perform 4 blood glucose tests per day (pre-meal and before bedtime). Subjects will be asked to scan the sensor when each blood glucose test is performed.

Primary outcomes

  1. Point Accuracy Determined as % within Consensus Error Grid Zone A

    Time frame: Up to 35 days

    Point accuracy of Sensor based glucose values compared to capillary fingerstick blood glucose, determined as % within Consensus Error Grid Zone A.

Sponsors and collaborators

Lead sponsor

Abbott Diabetes Care

Industry

Registry information

Official study title

Paediatric Use of the Abbott Sensor Based Glucose Monitoring System - an Accuracy Evaluation

Acronym: PUGS

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 14, 2018
Registry last updated
Aug 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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