DiabetesNCT06035367
SKAMo-2: the Real-life Test of Continuous Photoacoustic Signal by Neogly in Patients With Type I Diabetes
A study testing Non-invasive continuous monitoring device to record photoacoustic signal in people with Diabetes, run by Eclypia at 1 site in France.
Trial summary
Diabetes is one of the very common and chronic diseases in the present world, which affects children and adults. Diabetes is characterized by hyperglycemia. Hence, diabetic patients need to precisely monitor their blood sugar level regularly a few times a day. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Diabetes
- What is being tested?
- Non-invasive continuous monitoring device to record photoacoustic signal
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jul 2023to 30 Oct 2023
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients with type I diabetes
- male and female patients aged 18 to 50 years
- wearing a FreeStyle Libre CGM and giving the access of collected data
- using insulin pump or insulin pen and giving the access of collected data
- willing to wear the investigational device continuously throughout the study (24h/24h)
- affiliated with French Social Security
- having signed the informed consent form
Who cannot join
- any skin disease (inflammatory diseases of skin, cancer of skin, infectious diseases of skin, change in skin color...)
- any serious disease that could interfere with the study
- body mass index (BMI) > 30kg/m2
- scars or tattoos on the upper side of the wrist wearing the investigational device
- who may have an allergy to one of the material used in the device
- who have magnetic resonance imagery (MRI), computed tomography (CT) scan or high frequency electrical heat (diathermy) treatment during the study
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- persons mentioned in articles L1121-5 to L1121-9 of the public health code (Pregnancy or Lactation ; Females with childbearing potential, defined as a premenopausal female and not using an effective form of birth control*; Person deprived of liberty by judicial order ; Person under guardianship or curatorship ; Minors ; Adults who are incapable or unable to give their consent ; Cross-over situations)
- who would receive more than 4500 euros in compensation due to his or her participation in other research involving the human person in the 12 months preceding this study
- who, in the judgment of the investigator, are likely to be non-compliant or uncooperative during the study, or unable to cooperate because of language problem, poor mental development
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Grenoble Alpes
Grenoble, 38043
Centre d'investigation clinique Centre d'investigation clinique, 334.76.767.575, CIC@chu-grenoble.fr
Pierre-Yves Pr BENHAMOU, principal investigator
About this study
Diabetes is one of the very common and chronic diseases in the present world, which affects children and adults. Diabetes is characterized by hyperglycemia. Hence, diabetic patients need to precisely monitor their blood sugar level regularly a few times a day. Currently, the solutions for self-monitoring blood glucose are invasive (finger prick method, continuous glucose monitoring (CGM) using microneedle).The fully non-invasive CGM approaches still are in high demand.
The medical device is developed, ultimately, to continuously measure the blood glucose level from continuous in-vivo photoacoustic signal.
Read more
For this study, the goal is to check if the signal collected by the investigational device is relevant and exploitable in patients with type I diabetes.
The main task of participants is to wear the investigational device during one week.
- Conditions
- Diabetes
- Being tested
- Non-invasive continuous monitoring device to record photoacoustic signal
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive continuous monitoring device to record photoacoustic signalDevice
Neogly is in two parts, the measurement head, to be worn on the wrist and the power box, to be worn on the forearm or upper arm. The ribbon cable makes the connection between the two parts.
A handset is used to start/stop the device. The medical device record a continuous photoacoustic signal.
| Study group | Role | What they receive |
|---|---|---|
| Wearing the non-invasive continous monitoring device during one week to record photoacoustic signal | Experimental | Wearing the non-invasive continous monitoring device during one week to record photoacoustic signal Receives: Device: Non-invasive continuous monitoring device to record photoacoustic signal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Value of absolute photoacoustic signal on the participant arm
The first endpoint is evaluated by the value of photoacoustic signal on the participant arm. To check if if the photoacoustic data of the investigational device are relevant and exploitable. This signal should be above a given threshold, corresponding to an absolute photoacoustic value at least three times higher than this measured when the device is not worn.
Measured: around one week (7 to 9 days)
Secondary outcomes (3)
assess the safety by the general clinical evaluation (normal, abnormal, abnormal not clinically significant)
baseline (V1) and after the device wearing (V2)
Measured: around one week (7 to 9 days)
assess the safety by number/class of adverse events
definitions of AE from European Medical Device Regulation 2017/745
Measured: during one week (7 to 9 days)
assess the tolerability of the investigational device by a usability questionnaire
some questions with scales from 1 to 10 (no total score) and other questions with a free field to collect the user feedback about the size, appearance, comfort, operation of the device and the suggestions for device improvement
Measured: around one week (7 to 9 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start6 Jul 2023
- Primary completion30 Oct 2023 (estimated)
- Study completion30 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eclypia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06035367
- Sponsor's protocol ID
- 2022-A02789-34
- Status last verified
- Sep 2023
- First submitted
- 5 Jul 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SKAMo-2: the Real-life Test of Continuous Photoacoustic Signal by Neogly in Patients With Type I Diabetes
- ClinicalTrials.gov ID
- NCT06035367
- Acronym / sponsor ID
- 2022-A02789-34
- Conditions
- Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- EclypiaIndustry (pharma, biotech, devices)
- Study start
- 6 Jul 2023 (actual)
- Primary completion
- 30 Oct 2023 (estimated)
- Study completion
- 30 Oct 2023 (estimated)
- First posted
- 13 Sep 2023 (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.
Diabetes is one of the very common and chronic diseases in the present world, which affects children and adults. Diabetes is characterized by hyperglycemia. Hence, diabetic patients need to precisely monitor their blood sugar level regularly a few times a day. Currently, the solutions for self-monitoring blood glucose are invasive (finger prick method, continuous glucose monitoring (CGM) using microneedle).The fully non-invasive CGM approaches still are in high demand.
The medical device is developed, ultimately, to continuously measure the blood glucose level from continuous in-vivo photoacoustic signal.
For this study, the goal is to check if the signal collected by the investigational device is relevant and exploitable in patients with type I diabetes.
The main task of participants is to wear the investigational device during one week.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Wearing the non-invasive continous monitoring device during one week to record photoacoustic signal | Experimental | Device: Non-invasive continuous monitoring device to record photoacoustic signalWearing the non-invasive continous monitoring device during one week to record photoacoustic signal |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- patients with type I diabetes
- male and female patients aged 18 to 50 years
- wearing a FreeStyle Libre CGM and giving the access of collected data
- using insulin pump or insulin pen and giving the access of collected data
- willing to wear the investigational device continuously throughout the study (24h/24h)
Key exclusion criteria (9 listed)
- any skin disease (inflammatory diseases of skin, cancer of skin, infectious diseases of skin, change in skin color...)
- any serious disease that could interfere with the study
- body mass index (BMI) > 30kg/m2
- scars or tattoos on the upper side of the wrist wearing the investigational device
- who may have an allergy to one of the material used in the device
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 continuous monitoring device to record photoacoustic signalNeogly is in two parts, the measurement head, to be worn on the wrist and the power box, to be worn on the forearm or upper arm. The ribbon cable makes the connection between the two parts. A handset is used to start/stop the device. The medical device record a continuous photoacoustic signal. | Device | Wearing the non-invasive continous monitoring device during one week to record photoacoustic signal |
Primary outcome
Value of absolute photoacoustic signal on the participant arm
Time frame: around one week (7 to 9 days)
The first endpoint is evaluated by the value of photoacoustic signal on the participant arm. To check if if the photoacoustic data of the investigational device are relevant and exploitable. This signal should be above a given threshold, corresponding to an absolute photoacoustic value at least three times higher than this measured when the device is not worn.
3 secondary outcomes
assess the safety by the general clinical evaluation (normal, abnormal, abnormal not clinically significant)
Time frame: around one week (7 to 9 days)
assess the safety by number/class of adverse events
Time frame: during one week (7 to 9 days)
assess the tolerability of the investigational device by a usability questionnaire
Time frame: around one week (7 to 9 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive continuous monitoring device to record photoacoustic signal in people with Diabetes, run by Eclypia at 1 site in France.
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 7 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 13 Sep 2023. 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 France. 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 Eclypia (33476767383, contact@eclypia.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Value of absolute photoacoustic signal on the participant arm (time frame: around one week (7 to 9 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 13 Sep 2023.