NCT03433573

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
103

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus

Timeline
Completed

Started Feb 2018

Shorter than P25 for not_applicable diabetes-mellitus

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 14, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

February 16, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 11, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 11, 2018

Completed
Last Updated

August 29, 2018

Status Verified

August 1, 2018

Enrollment Period

3 months

First QC Date

February 9, 2018

Last Update Submit

August 28, 2018

Conditions

Diabetes Mellitus

Outcome Measures

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.

    Up to 35 days

Study Arms (1)

Intervention

EXPERIMENTAL

Abbott Sensor Based Glucose Monitoring System

Device: Abbott Sensor Based Glucose Monitoring System

Interventions

Abbott Sensor Based Glucose Monitoring SystemDEVICE

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.

Intervention

Eligibility Criteria

Age4 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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).

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Leeds Teaching Hospitals NHS Trust

Leeds, LS9 7TF, United Kingdom

Location

Alder Hey Children's NHS Foundation Trust

Liverpool, L14 5AB, United Kingdom

Location

Pennine Acute Hospitals NHS Trust

Manchester, M8 5RB, United Kingdom

Location

Northampton General Hospitals NHS Trust

Northampton, NN1 5BD, United Kingdom

Location

Nottingham University Hospitals NHS Trust

Nottingham, NG5 1PB, United Kingdom

Location

Salisbury NHS Foundation Trust

Salisbury, SP2 8BJ, United Kingdom

Location

Southampton University Hospitals NHS Trust

Southampton, SO16 6YD, United Kingdom

Location

Great Western Hospitals NHS Foundation Trust

Swindon, SN3 6BB, United Kingdom

Location

Taunton and Somerset NHS Foundation Trust

Taunton, TA1 5DA, United Kingdom

Location

St George's Healthcare NHS Trust

Tooting, SW17 0QT, United Kingdom

Location

Royal Cornwall Hospitals NHS Trust

Truro, TR1 3LQ, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2018

First Posted

February 14, 2018

Study Start

February 16, 2018

Primary Completion

May 11, 2018

Study Completion

May 11, 2018

Last Updated

August 29, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

GB(11)