ClinicalTrials.gov

History of Changes for Study: NCT02388815
Abbott Sensor Based Glucose Monitoring System Paediatric Study (BEAGLE)
Latest version (submitted July 11, 2016) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 March 13, 2015 None (earliest Version on record)
2 April 15, 2015 Study Status and Contacts/Locations
3 June 5, 2015 Recruitment Status, Study Status and Contacts/Locations
4 October 8, 2015 Recruitment Status, Study Status and Study Design
5 March 14, 2016 Study Status, Results and Eligibility
6 June 9, 2016 Participant Flow, Adverse Events, Outcome Measures, Study Status
7 July 11, 2016 Adverse Events, Outcome Measures, Baseline Characteristics and Study Status
Comparison Format:

Scroll up to access the controls

Study NCT02388815
Submitted Date:  March 13, 2015 (v1)

Open or close this module Study Identification
Unique Protocol ID: ADC-UK-VAL-14022
Brief Title: Abbott Sensor Based Glucose Monitoring System Paediatric Study (BEAGLE)
Official Title: Evaluation of the Accuracy of the Abbott Sensor Based Glucose Monitoring System - Paediatric Label Extension Study (CE)
Secondary IDs:
Open or close this module Study Status
Record Verification: March 2015
Overall Status: Recruiting
Study Start: March 2015
Primary Completion: July 2015 [Anticipated]
Study Completion: September 2015 [Anticipated]
First Submitted: March 10, 2015
First Submitted that
Met QC Criteria:
March 13, 2015
First Posted: March 17, 2015 [Estimate]
Last Update Submitted that
Met QC Criteria:
March 13, 2015
Last Update Posted: March 17, 2015 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Abbott Diabetes Care
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
Brief Summary: To evaluate the point accuracy of the Abbott Sensor Based Glucose Monitoring System when used at home by children with diabetes.
Detailed Description:
Open or close this module Conditions
Conditions: Diabetes Mellitus
Keywords: Diabetes Mellitus
Sensing Technology
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Other
Study Phase: Not Applicable
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 90 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Intervention
FreeStyle Libre Flash Glucose Monitoring System
Device: FreeStyle Libre Flash Glucose Monitoring System

Subjects will wear the Abbott Sensor Based Glucose Monitoring System masked for 14 days.

During these 14 days subjects will be asked to perform 4 blood glucose tests (meals time and before bedtime) per day. At the same time as the blood glucose test a sensor scan is performed.

Open or close this module Outcome Measures
Primary Outcome Measures:
1. Point Accuracy
[ Time Frame: 14 days ]

Point accuracy of Sensor based glucose values versus fingerstick blood glucose determined as % within Consensus Error Grid zone A
Open or close this module Eligibility
Minimum Age: 4 Years
Maximum Age: 17 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Age ≥ 4 years, ≤17 years
  • Each participant has an identified Caregiver of ≥18 years
  • Type 1 or type 2 diabetes using insulin administered by injections or CSII
  • Currently testing blood glucose, on average at least 2 times per day
  • 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 continuous glucose monitoring (CGM) device
  • 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)
Open or close this module Contacts/Locations
Central Contact Person: Jolyon Bugler
Telephone: +44 1993 863164
Email: joe.bugler@abbott.com
Locations: United Kingdom
University Hospitals Bristol NHS Foundation Trust
[Not yet recruiting]
Bristol, United Kingdom, BS1 3NU
Contact:Contact: Julian Hamilton-Shield
Contact:Principal Investigator: Julian Hamilton-Shield
Cambridge University Hospitals NHS Foundation Trust
[Not yet recruiting]
Cambridge, United Kingdom, CB2 0QQ
Contact:Contact: Carlo Acerini
Contact:Principal Investigator: Carlo Acerini
Royal Devon and Exeter NHS Foundation Trust
[Not yet recruiting]
Exeter, United Kingdom, EX2 5DW
Contact:Contact: Chris Moudiotis
Contact:Principal Investigator: Chris Moudiotis
Harrogate & District NHS Foundation Trust
[Not yet recruiting]
Harrogate, United Kingdom, HG2 7SX
Contact:Contact: Shakeel Rahman
Contact:Principal Investigator: Shakeel Rahman
St. James University Hospital, Leeds Teaching Hospitals NHS Trust
[Not yet recruiting]
Leeds, United Kingdom, LS9 7TF
Contact:Contact: Fiona Campbell
Contact:Principal Investigator: Fiona Cambell
Northampton General Hospital NHS Trust
[Not yet recruiting]
Northampton, United Kingdom, NNI 5BD
Contact:Contact: Anne Smith
Contact:Principal Investigator: Anne Smith
Nottingham University Hospitals NHS Trust
[Not yet recruiting]
Nottingham, United Kingdom, NG7 2UH
Contact:Contact: Tabitha Randell
Contact:Principal Investigator: Tabitha Randell
Oxford Radcliffe Hospital NHS Trust
[Recruiting]
Oxford, United Kingdom, OX3 9DU
Contact:Contact: Julie Edge
Contact:Principal Investigator: Julie Edge
Southampton University Hospital NHS Trust
[Recruiting]
Southampton, United Kingdom, SO16 6YD
Contact:Contact: Nicola Trevelyan
Contact:Principal Investigator: Nicola Trevelyan
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services