Diabetes MellitusNCT03870971
User Evaluation of the Invasive Component of the CNOGA TensorTip COMBO GLUCOMETER (CoG)
A study testing blood glucose measurement in people with Diabetes Mellitus, run by Sciema UG at 1 site in United States.
Trial summary
Open label, prospective, comparative, multi-center study. All participants will get an introduction to the invasive component of the TENSORTIP COG by means of the instructions for use in English language only (incl. an illustrated short manual) and will be asked to perform a reading without further device training. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- blood glucose measurement
- How many people
- 543 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2019to 31 Aug 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients with type 1 or type 2 diabetes or healthy
- Subjects who are able to complete informed consent form (by him/herself or by his/her guardian);
- 18 years old and above;
Who cannot join
- Does not meet inclusion criteria;
- Subjects with any other severe disease in the discretion of the investigator
- Not capable to read English user instructions at the discretion of the patient
- Pregnancy or Nursing mothers
- Any condition that may prevent participants from successful participation in the trial (in discretion of the investigator)
- Illiteracy
Trial locations and contacts
1 site in 1 country.
United States1 site
Rainier Clinical Research Center, Inc.
Renton, Washington, 98057
About this study
Open label, prospective, comparative, multi-center study. All participants will get an introduction to the invasive component of the TENSORTIP COG by means of the instructions for use in English language only (incl. an illustrated short manual) and will be asked to perform a reading without further device training. Thereafter, a healthcare professional will perform an additional reading with the reference method (YSI 2300 STAT plus). In addition, blood will be drawn for determination of hematocrit. In the study, a minimum of 10 test strip vials that cover a minimum of 3 strip lots will be used. In addition multiple devices will be employed. After completion of the study the study participants will be given a questionnaire to fill out.
- Conditions
- Diabetes Mellitus
- Being tested
- blood glucose measurement
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood glucose measurementOther
After the patient has performed the manual reading, the investigator or staff member will obtain another capillary blood sample and a reference reading by means of the YSI 2300 Stat plus analyzer will be performed and recorded. If patients need more than one attempt to get a successful blood glucose reading, the number of attempts will be documented. A questionnaire needs to filled by the participant
What is being measured
The primary outcome is the main question the study is designed to answer.
measurement performance
invasive CoG (study device) blood glucose measurement in comparison to blood glucose measurment of a comparator device (YSI 2300 STAT Plus).
Measured: up to 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start4 Feb 2019
- Primary completion8 Jul 2019
- Study completion31 Aug 2019
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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 543 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sciema UG
- Sponsor type
- University, hospital or other
- Collaborators
- Cnoga Medical Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03870971
- Sponsor's protocol ID
- CNG-NGM-005
- Status last verified
- Jan 2019
- First submitted
- 12 Feb 2019
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- User Evaluation of the Invasive Component of the CNOGA TensorTip COMBO GLUCOMETER (CoG)
- ClinicalTrials.gov ID
- NCT03870971
- Acronym / sponsor ID
- CNG-NGM-005
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 543 participants (actual)
- Lead sponsor
- Sciema UGUniversity, hospital or other
- Collaborators
- Cnoga Medical Ltd.
- Study start
- 4 Feb 2019 (actual)
- Primary completion
- 8 Jul 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 12 Mar 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.
Open label, prospective, comparative, multi-center study. All participants will get an introduction to the invasive component of the TENSORTIP COG by means of the instructions for use in English language only (incl. an illustrated short manual) and will be asked to perform a reading without further device training. Thereafter, a healthcare professional will perform an additional reading with the reference method (YSI 2300 STAT plus). In addition, blood will be drawn for determination of hematocrit. In the study, a minimum of 10 test strip vials that cover a minimum of 3 strip lots will be used. In addition multiple devices will be employed. After completion of the study the study participants will be given a questionnaire to fill out.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients with type 1 or type 2 diabetes or healthy
- Subjects who are able to complete informed consent form (by him/herself or by his/her guardian);
- 18 years old and above;
Key exclusion criteria (6 listed)
- Does not meet inclusion criteria;
- Subjects with any other severe disease in the discretion of the investigator
- Not capable to read English user instructions at the discretion of the patient
- Pregnancy or Nursing mothers
- Any condition that may prevent participants from successful participation in the trial (in discretion of the investigator)
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 |
|---|---|---|
| blood glucose measurementAfter the patient has performed the manual reading, the investigator or staff member will obtain another capillary blood sample and a reference reading by means of the YSI 2300 Stat plus analyzer will be performed and recorded. If patients need more than one attempt to get a successful blood glucose reading, the number of attempts will be documented. A questionnaire needs to filled by the participant | Other | – |
Primary outcome
measurement performance
Time frame: up to 1 day
invasive CoG (study device) blood glucose measurement in comparison to blood glucose measurment of a comparator device (YSI 2300 STAT Plus).
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 18 Jan 2020.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood glucose measurement in people with Diabetes Mellitus, run by Sciema UG at 1 site in United States.
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 3 inclusion and 6 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 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
measurement performance (time frame: up to 1 day). 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 18 Jan 2020.