Diabetes MellitusNCT03851549
A User Performance and System Use Evaluation of a New Blood Glucose Monitoring System ( BGMS)
A study testing New BGMS (US) in people with Diabetes Mellitus, run by LifeScan Scotland Ltd at 4 sites in 2 countries.
Trial summary
This study is the US Regulatory Clinical Evaluation - User Performance and System Use Evaluation of a new Blood Glucose Monitoring System (BGMS). Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- New BGMS (US)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 12 Mar 2019to 19 Apr 2019
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Summary of inclusion criteria:
Subject is at least 12 years old. Informed Consent. Subject has a current diagnosis of type 1 or type 2 diabetes mellitus. Subject reads and understands English. Subject is currently performing unassisted self-monitoring of blood glucose (SMBG) OR naive to SMBG for a 10% sub-group.
Summary of exclusion criteria:
Conflict of interest. Technical expertise.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United Kingdom3 sites
Birmingham Heartlands Hospital
Birmingham, B9 5SS
Laura Ritchie, lritchi6@its.jnj.com
Dr. Srikanth Bellary
Royal Infirmary of Edinburgh
Edinburgh, Lothian, EH16 4SA
Barry Irvine, BIRVINE1@its.jnj.com
Dr. Nicola Zammitt
Centre for Health Science
Inverness, IV2 3JH
Danielle King, dking38@its.jnj.com
Dr. David Macfarlane
Germany1 site
Institut für Diabetes-Technologie
Ulm, D-89081
Annnette Baumstark, annette.baumstark@idt-ulm.de
Barry Irvine, BIRVINE1@its.jnj.com
About this study
Official title: US Regulatory Clinical Evaluation - User Performance and System Use Evaluation of a New Blood Glucose Monitoring System.
This study is the US Regulatory Clinical Evaluation - User Performance and System Use Evaluation of a new Blood Glucose Monitoring System (BGMS).
Read the detailed description
User Performance - Assess Lay User fingertip test results obtained on the new BGMS compared to a validated method (YSI 2300 STAT PLUS glucose analyzer results) according to FDA Guidance 2016 section VI.C.
Assess System Use of the new BGMS, as relevant to self-testing technique, with reference to the Owner's Booklet.
- Conditions
- Diabetes Mellitus
- Being tested
- New BGMS (US)
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New BGMS (US)Device
New blood glucose monitoring system / In vitro diagnostic device (IVDD)
| Study group | Role | What they receive |
|---|---|---|
| Blood Glucose monitoring System (BGMS) | Experimental | Intervention: Blood Glucose monitoring Systems (BGMS): Results obtained from the new BGMS for UP are compared to a reference instrument (YSI 2300) Receives: Device: New BGMS (US) |
What is being measured
The primary outcome is the main question the study is designed to answer.
User Performance ( UP)
User Performance evaluation (referred to as Method Comparison / User Evaluation in FDA Guidance 2016): Lay User accuracy of BGMS by comparison of meter blood glucose results to a laboratory reference instrument.
Measured: < 30 minutes
System Use Evaluation
System usability: Lay user system use evaluation (as relevant to fingertip self-testing) by study personnel observation and completion of a scoring questionnaire.
Measured: < 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2019
- Study start12 Mar 2019 (estimated)
- Primary completion19 Apr 2019 (estimated)
- Study completion19 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LifeScan Scotland Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Institut für Diabetes-Technologie ( IfDT)
- Responsible party
- Sponsor
- Investigators
- Kirsty Macleod, Study director, LifeScan Scotland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03851549
- Sponsor's protocol ID
- 3178226
- Status last verified
- Mar 2019
- First submitted
- 21 Feb 2019
- Last updated
- 8 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Katz LB, Stewart L, King D, Cameron H. Meeting the New FDA Standard for Accuracy of Self-Monitoring Blood Glucose Test Systems Intended for Home Use by Lay Users. J Diabetes Sci Technol. 2020 Sep;14(5):912-916. doi: 10.1177/1932296820906184. Epub 2020 Feb 14.
PubMed 32059615
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- US Regulatory Clinical Evaluation - User Performance and System Use Evaluation of a New Blood Glucose Monitoring System.
- ClinicalTrials.gov ID
- NCT03851549
- Acronym / sponsor ID
- 3178226
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- LifeScan Scotland LtdIndustry (pharma, biotech, devices)
- Collaborators
- Institut für Diabetes-Technologie ( IfDT)
- Study start
- 12 Mar 2019 (estimated)
- Primary completion
- 19 Apr 2019 (estimated)
- Study completion
- 19 Apr 2019 (estimated)
- First posted
- 22 Feb 2019 (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.
This study is the US Regulatory Clinical Evaluation - User Performance and System Use Evaluation of a new Blood Glucose Monitoring System (BGMS).
Detailed description
User Performance - Assess Lay User fingertip test results obtained on the new BGMS compared to a validated method (YSI 2300 STAT PLUS glucose analyzer results) according to FDA Guidance 2016 section VI.C.
Assess System Use of the new BGMS, as relevant to self-testing technique, with reference to the Owner's Booklet.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood Glucose monitoring System (BGMS) | Experimental | Device: New BGMS (US)Intervention: Blood Glucose monitoring Systems (BGMS): Results obtained from the new BGMS for UP are compared to a reference instrument (YSI 2300) |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| New BGMS (US)New blood glucose monitoring system / In vitro diagnostic device (IVDD) | Device | Blood Glucose monitoring System (BGMS) |
Primary outcome
User Performance ( UP)
Time frame: < 30 minutes
User Performance evaluation (referred to as Method Comparison / User Evaluation in FDA Guidance 2016): Lay User accuracy of BGMS by comparison of meter blood glucose results to a laboratory reference instrument.
System Use Evaluation
Time frame: < 30 minutes
System usability: Lay user system use evaluation (as relevant to fingertip self-testing) by study personnel observation and completion of a scoring questionnaire.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2019.
- Derived from this study: PubMed 32059615Katz LB, Stewart L, King D, Cameron H. Meeting the New FDA Standard for Accuracy of Self-Monitoring Blood Glucose Test Systems Intended for Home Use by Lay Users. J Diabetes Sci Technol. 2020 Sep;14(5):912-916. doi: 10.1177/1932296820906184. Epub 2020 Feb 14.
- Individual participant dataSharing planned: Undecided
Related trials for Diabetes Mellitus
Active, not recruitingPhase 3
Cadisegliatin as Adjunctive Therapy to Insulin in Participants With Type 1 Diabetes
Diabetes Mellitus, Type 1
Not yet recruiting
SWitching to Appropriate Prescription in Cardiovascular-Kidney-Metabolic Syndrome
Cardiovascular-kidney-metabolic Syndrome, Diabete Type 2
Active, not recruiting
Pilot of Continuous Glucose Monitor-Augmented Food Is Medicine
Nutrition, Type 2 Diabetes
RecruitingObservational study
Safety and Effect of Peripheral Nerve Decompression Combined With Peripheral Nerve Stimulation for Painful Diabetic Peripheral Neuropathy
Painful Diabetic Peripheral Neuropathy, Diabetes Complication
Recruiting
Continuous Monitoring of Plantar Temperature Variations Using Connected Insoles and a Mobile Application for Diabetic Foot.
Diabetic Foot Disease, Diabetic Foot Infection
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.
Kirsty Macleod study director
LifeScan Scotland
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New BGMS (US) in people with Diabetes Mellitus, run by LifeScan Scotland Ltd at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 8 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom, Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lorna Stewart (+44 01463 721000, LSTEWAR5@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
User Performance ( UP) (time frame: < 30 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03851549, which also lists 1 linked publication.
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 8 Mar 2019.