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CompletedNCT03433573PUGSUpdated Aug 29, 2018

Paediatric Use of the Abbott Sensor Based Glucose Monitoring System

An interventional study of Abbott Sensor Based Glucose Monitoring System in Diabetes Mellitus, sponsored by Abbott Diabetes Care. Completed at 11 sites in United Kingdom. Open to participants aged 4 Years to 17 Years. Per ClinicalTrials.gov, last updated 2018-08-29.

Sponsored by Abbott Diabetes Care · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
103
Allocation
Not applicable
Ages
4 Years to 17 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Diabetes Mellitus
03

Who can participate

Ages eligible
4 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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).
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
103 participants (actual)

Study arms

  • Experimental
    Intervention

    Abbott Sensor Based Glucose Monitoring System

    Device: Abbott Sensor Based Glucose Monitoring System

Interventions

  • DeviceAbbott 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.

05

What researchers measure

Primary outcomes

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

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

    Time frame: Up to 35 days

06

Study locations

11 sites
  • Leeds Teaching Hospitals NHS Trust
    Leeds, LS9 7TF, United Kingdom
  • Alder Hey Children's NHS Foundation Trust
    Liverpool, L14 5AB, United Kingdom
  • Pennine Acute Hospitals NHS Trust
    Manchester, M8 5RB, United Kingdom
  • Northampton General Hospitals NHS Trust
    Northampton, NN1 5BD, United Kingdom
  • Nottingham University Hospitals NHS Trust
    Nottingham, NG5 1PB, United Kingdom
  • Salisbury NHS Foundation Trust
    Salisbury, SP2 8BJ, United Kingdom
  • Southampton University Hospitals NHS Trust
    Southampton, SO16 6YD, United Kingdom
  • Great Western Hospitals NHS Foundation Trust
    Swindon, SN3 6BB, United Kingdom
  • Taunton and Somerset NHS Foundation Trust
    Taunton, TA1 5DA, United Kingdom
  • St George's Healthcare NHS Trust
    Tooting, SW17 0QT, United Kingdom
  • Royal Cornwall Hospitals NHS Trust
    Truro, TR1 3LQ, United Kingdom
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03433573
Lead sponsor
Abbott Diabetes Care
Responsible party
Sponsor
First posted
Feb 14, 2018
Start date
Feb 16, 2018
Primary completion
May 11, 2018
Completion
May 11, 2018
Last update
Aug 29, 2018

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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