Paediatric Use of the Abbott Sensor Based Glucose Monitoring System (PUGS)

August 28, 2018 updated by: Abbott Diabetes Care

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

103

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Leeds, United Kingdom, LS9 7TF
        • Leeds Teaching Hospitals NHS Trust
      • Liverpool, United Kingdom, L14 5AB
        • Alder Hey Children's NHS Foundation Trust
      • Manchester, United Kingdom, M8 5RB
        • Pennine Acute Hospitals NHS Trust
      • Northampton, United Kingdom, NN1 5BD
        • Northampton General Hospitals NHS Trust
      • Nottingham, United Kingdom, NG5 1PB
        • Nottingham University Hospitals Nhs Trust
      • Salisbury, United Kingdom, SP2 8BJ
        • Salisbury Nhs Foundation Trust
      • Southampton, United Kingdom, SO16 6YD
        • Southampton University Hospitals NHS Trust
      • Swindon, United Kingdom, SN3 6BB
        • Great Western Hospitals NHS Foundation Trust
      • Taunton, United Kingdom, TA1 5DA
        • Taunton and Somerset NHS Foundation Trust
      • Tooting, United Kingdom, SW17 0QT
        • St George's Healthcare NHS Trust
      • Truro, United Kingdom, TR1 3LQ
        • Royal Cornwall Hospitals NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Abbott Sensor Based Glucose Monitoring System
Device: Abbott Sensor Based Glucose Monitoring System
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 35 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Diabetes Care

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 16, 2018

Primary Completion (Actual)

May 11, 2018

Study Completion (Actual)

May 11, 2018

Study Registration Dates

First Submitted

February 9, 2018

First Submitted That Met QC Criteria

February 9, 2018

First Posted (Actual)

February 14, 2018

Study Record Updates

Last Update Posted (Actual)

August 29, 2018

Last Update Submitted That Met QC Criteria

August 28, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • ADC-UK-VAL-17032

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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