Diabetes MellitusNCT03840161
Use of CoG by Patients With Diabetes Mellitus
An observational study of Diabetes Mellitus, run by Sciema UG at 1 site in United States.
Trial summary
The CNOGA Combo Glucometer (CoG) employs an invasive glucose meter using blood glucose teststrips and requiering a capillary blood sample obtained from a fingerstick and in addition, a non-invasive optical component for prediction of tissue glucose at the fingertip. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- non-invasive tissue glucose prediction
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2018to 31 Mar 2019
- Phase
- Observational
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with diabetes mellitus (type 1 or type 2, any treatment) of other than caucasian origin, who are experienced with performing blood glucose self-testing.
Who may be able to join
- Patients with Type 1 or Type 2 diabetes of Afro-American, Hispanic, or Asian-American origin
- Subjects who are able to provide informed consent (by him/herself or by his/her guardian);
- 18 years old and above;
- HbA1c < 10 %
- Anatomically suitable finger as determined by the clinical investigator and detailed in section 4
Who cannot join
- Does not meet inclusion criteria;
- Subjects requiring dialysis;
- Any conditions that may hamper good visual contact between the finger and sensor, such as raised birthmarks, scars and/or tattoos;
- Pregnancy;
- Nursing mothers;
- Any skin injuries on the measured finger;
- Severe disease conditions (cancer etc.)
- Any condition that may prevent patients from successful participation in the trial (in discretion of the investigator)
Trial locations and contacts
1 site in 1 country.
United States1 site
Mills-Penisnsula Medical Center
San Mateo, California, 94596
About this study
Official title: Evaluation of the CNOGA TensorTip COMBO GLUCOMETER (CoG) During Standardized Meal Test and Consecutive Home Use by Patients With Diabetes Mellitus
The CNOGA Combo Glucometer (CoG) employs an invasive glucose meter using blood glucose teststrips and requiering a capillary blood sample obtained from a fingerstick and in addition, a non-invasive optical component for prediction of tissue glucose at the fingertip. In this study, participants will use both devices during meal tests and also at home during routine care. The results from the device will be compared to a standard reference method and will be used to determine the accuracy of the two device components.
Read the detailed description
The trial starts with a screening and training visit (V1). This is followed by an individual calibration period for the non-invasive device component by means of multiple parallel measurements with the invasive and the noninvasive device component. This will be done by the participants at home. Thereafter, the participants will come to the study site and will ingest a standardized meal (V2). Blood will be drawn for assessment of HbA1c and biochemical safety parameters. During the next 3 hours, 11 fingersticks will be made to obtain capillary blood samples for comparator readings with the two CoG components and with a laboratory reference method (YSI gucose analyzer). The patients will now continue to use the devices at home for three months, but are not allowed to use any CoG result for treatment decisions. In an interim visit after 6 weeks (V3), blood will be drawrn for HbA1c and biochemical safety parameters and three comparison measurements will be made with the CoG device components and the laboratory reference method. At the final visit after 12 weeks (V4), the procedures of the first meal test visit (V2) will be repeated, which conludes that study. In addition, the participants will be asked to complete a device satisfaction questionnaire at V2, V3, and V4.
- Conditions
- Diabetes Mellitus
- Being tested
- non-invasive tissue glucose prediction
- Keywords
- Diabetes mellitus Type 1, Diabetes mellitus Type 2, blood glucose self-testing, non-invasive tissue glucose prediction, optical pain-free glucose testing
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-invasive tissue glucose predictionDevice
Also called invasive blood glucose measurement
Generation of non-invasive and invasive glucose readings for comparison with a standard laboratory reference glucose determination method (YSI glucose analyzer)
What is being measured
The primary outcome is the main question the study is designed to answer.
CoG accuracy in measuring glucose levels (non-invasively) during a standardized meal experiment.
Comparison of non-invasive CoG device measurements (tissue glucose in mg/dL) with the results of a standard laboratory reference method (YSI glucose analyzer, blood glucose in mg/dL) by consensus-error grid analysis
Measured: Experiment will be performed twice within 3 months
CoG accuracy in monitoring glucose levels (invasively) during a standardized meal experiment.
Comparison of CoG invasive device readings (blood glucose in mg/dL) with the results of a standard laboratory reference method (YSI glucose analyzer, blood glucose in mg/dL) by consensus-error grid analysis
Measured: Experiment will be performed twice within 3 months
Secondary outcomes (2)
Impact of the CoG on long-term (three month) glycemic control (HbA1c using standard laboratory procedures) in patients with type 1 and 2 diabetes
Change in HbA1c from baseline after 6 weeks and 12 weeks
Measured: 3 months
Treatment satisfaction questionnaire
Change in device satisfaction questionnaire score after 6 weeks and 12 weeks
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start16 Jul 2018
- Primary completion28 Feb 2019
- Study completion31 Mar 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sciema UG
- Sponsor type
- University, hospital or other
- Collaborators
- Cnoga Medical Ltd.
- Responsible party
- Sponsor
- Investigators
- Filiz Demircik, PhD, Study director, Sciema UG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03840161
- Sponsor's protocol ID
- CNG-NGM-003
- Status last verified
- Feb 2019
- First submitted
- 21 Jul 2018
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- 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
- Evaluation of the CNOGA TensorTip COMBO GLUCOMETER (CoG) During Standardized Meal Test and Consecutive Home Use by Patients With Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT03840161
- Acronym / sponsor ID
- CNG-NGM-003
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes mellitus Type 1, Diabetes mellitus Type 2, blood glucose self-testing, non-invasive tissue glucose prediction, optical pain-free glucose testing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Sciema UGUniversity, hospital or other
- Collaborators
- Cnoga Medical Ltd.
- Study start
- 16 Jul 2018 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 15 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.
The CNOGA Combo Glucometer (CoG) employs an invasive glucose meter using blood glucose teststrips and requiering a capillary blood sample obtained from a fingerstick and in addition, a non-invasive optical component for prediction of tissue glucose at the fingertip. In this study, participants will use both devices during meal tests and also at home during routine care. The results from the device will be compared to a standard reference method and will be used to determine the accuracy of the two device components.
Detailed description
The trial starts with a screening and training visit (V1). This is followed by an individual calibration period for the non-invasive device component by means of multiple parallel measurements with the invasive and the noninvasive device component. This will be done by the participants at home. Thereafter, the participants will come to the study site and will ingest a standardized meal (V2). Blood will be drawn for assessment of HbA1c and biochemical safety parameters. During the next 3 hours, 11 fingersticks will be made to obtain capillary blood samples for comparator readings with the two CoG components and with a laboratory reference method (YSI gucose analyzer). The patients will now continue to use the devices at home for three months, but are not allowed to use any CoG result for treatment decisions. In an interim visit after 6 weeks (V3), blood will be drawrn for HbA1c and biochemical safety parameters and three comparison measurements will be made with the CoG device components and the laboratory reference method. At the final visit after 12 weeks (V4), the procedures of the first meal test visit (V2) will be repeated, which conludes that study. In addition, the participants will be asked to complete a device satisfaction questionnaire at V2, V3, and V4.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diabetes mellitus (type 1 or type 2, any treatment) of other than caucasian origin, who are experienced with performing blood glucose self-testing.
Key inclusion criteria (5 listed)
- Patients with Type 1 or Type 2 diabetes of Afro-American, Hispanic, or Asian-American origin
- Subjects who are able to provide informed consent (by him/herself or by his/her guardian);
- 18 years old and above;
- HbA1c < 10 %
- Anatomically suitable finger as determined by the clinical investigator and detailed in section 4
Key exclusion criteria (8 listed)
- Does not meet inclusion criteria;
- Subjects requiring dialysis;
- Any conditions that may hamper good visual contact between the finger and sensor, such as raised birthmarks, scars and/or tattoos;
- Pregnancy;
- Nursing mothers;
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 |
|---|---|---|
| non-invasive tissue glucose predictionAlso: invasive blood glucose measurementGeneration of non-invasive and invasive glucose readings for comparison with a standard laboratory reference glucose determination method (YSI glucose analyzer) | Device | – |
Primary outcome
CoG accuracy in measuring glucose levels (non-invasively) during a standardized meal experiment.
Time frame: Experiment will be performed twice within 3 months
Comparison of non-invasive CoG device measurements (tissue glucose in mg/dL) with the results of a standard laboratory reference method (YSI glucose analyzer, blood glucose in mg/dL) by consensus-error grid analysis
CoG accuracy in monitoring glucose levels (invasively) during a standardized meal experiment.
Time frame: Experiment will be performed twice within 3 months
Comparison of CoG invasive device readings (blood glucose in mg/dL) with the results of a standard laboratory reference method (YSI glucose analyzer, blood glucose in mg/dL) by consensus-error grid analysis
2 secondary outcomes
Impact of the CoG on long-term (three month) glycemic control (HbA1c using standard laboratory procedures) in patients with type 1 and 2 diabetes
Time frame: 3 months
Treatment satisfaction questionnaire
Time frame: 3 months
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.
Filiz Demircik, PhD study director
Sciema UG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 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 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?
CoG accuracy in measuring glucose levels (non-invasively) during a standardized meal experiment. (time frame: Experiment will be performed twice within 3 months). 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?
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.