Diabetes MellitusPUGSNCT03433573
Paediatric Use of the Abbott Sensor Based Glucose Monitoring System
A study testing Abbott Sensor Based Glucose Monitoring System in people with Diabetes Mellitus, run by Abbott Diabetes Care at 11 sites in United Kingdom.
Trial summary
Accuracy evaluation of the Abbott Sensor Based Glucose Monitoring System when used by children with diabetes. Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Abbott Sensor Based Glucose Monitoring System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 11 sitesUnited Kingdom
- Study dates
- 16 Feb 2018to 11 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United Kingdom11 sites
Leeds Teaching Hospitals NHS Trust
Leeds, LS9 7TF
Alder Hey Children's NHS Foundation Trust
Liverpool, L14 5AB
Pennine Acute Hospitals NHS Trust
Manchester, M8 5RB
Northampton General Hospitals NHS Trust
Northampton, NN1 5BD
Nottingham University Hospitals NHS Trust
Nottingham, NG5 1PB
Salisbury NHS Foundation Trust
Salisbury, SP2 8BJ
Southampton University Hospitals NHS Trust
Southampton, SO16 6YD
Great Western Hospitals NHS Foundation Trust
Swindon, SN3 6BB
Taunton and Somerset NHS Foundation Trust
Taunton, TA1 5DA
St George's Healthcare NHS Trust
Tooting, SW17 0QT
Royal Cornwall Hospitals NHS Trust
Truro, TR1 3LQ
About this study
Official title: 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.
- Conditions
- Diabetes Mellitus
- Being tested
- Abbott Sensor Based Glucose Monitoring System
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Abbott Sensor Based Glucose Monitoring System Receives: Device: Abbott Sensor Based Glucose Monitoring System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2018
- Study start16 Feb 2018
- Primary completion11 May 2018
- Study completion11 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Diabetes Care
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03433573
- Sponsor's protocol ID
- ADC-UK-VAL-17032
- Acronym
- PUGS
- Status last verified
- Aug 2018
- First submitted
- 9 Feb 2018
- Last updated
- 29 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paediatric Use of the Abbott Sensor Based Glucose Monitoring System - an Accuracy Evaluation
- ClinicalTrials.gov ID
- NCT03433573
- Acronym / sponsor ID
- PUGS / ADC-UK-VAL-17032
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Abbott Diabetes CareIndustry (pharma, biotech, devices)
- Study start
- 16 Feb 2018 (actual)
- Primary completion
- 11 May 2018 (actual)
- Study completion
- 11 May 2018 (actual)
- First posted
- 14 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Accuracy evaluation of the Abbott Sensor Based Glucose Monitoring System when used by children with diabetes.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Abbott Sensor Based Glucose Monitoring SystemAbbott Sensor Based Glucose Monitoring System |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abbott Sensor Based Glucose Monitoring SystemSubjects 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. | Device | Intervention |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abbott Sensor Based Glucose Monitoring System in people with Diabetes Mellitus, run by Abbott Diabetes Care at 11 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Point Accuracy Determined as % within Consensus Error Grid Zone A (time frame: Up to 35 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2018.