SKAMo-2: the Real-life Test of Continuous Photoacoustic Signal by Neogly in Patients With Type I Diabetes
NCT ID: NCT06035367
Last Updated: 2023-09-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
10 participants
INTERVENTIONAL
2023-07-06
2023-10-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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Wearing the non-invasive continous monitoring device during one week to record photoacoustic signal
Wearing the non-invasive continous monitoring device during one week to record photoacoustic signal
Non-invasive continuous monitoring device to record photoacoustic signal
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.
Interventions
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Non-invasive continuous monitoring device to record photoacoustic signal
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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
18 Years
50 Years
ALL
No
Sponsors
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Eclypia
INDUSTRY
Responsible Party
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Locations
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CHU Grenoble Alpes
Grenoble, , France
Countries
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Central Contacts
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Facility Contacts
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Centre d'investigation clinique Centre d'investigation clinique
Role: primary
Other Identifiers
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2022-A02789-34
Identifier Type: -
Identifier Source: org_study_id
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