Back to resultsSKAMo-2: the Real-life Test of Continuous Photoacoustic Signal by Neogly in Patients With Type I Diabetes
Primary Purpose
Diabetes
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Non-invasive continuous monitoring device to record photoacoustic signal
Sponsored by
About this trial
This is an interventional device feasibility trial for Diabetes
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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
Sites / Locations
- CHU Grenoble AlpesRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Wearing the non-invasive continous monitoring device during one week to record photoacoustic signal
Arm Description
Wearing the non-invasive continous monitoring device during one week to record photoacoustic signal
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
assess the safety by the general clinical evaluation (normal, abnormal, abnormal not clinically significant)
baseline (V1) and after the device wearing (V2)
assess the safety by number/class of adverse events
definitions of AE from European Medical Device Regulation 2017/745
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06035367
Brief Title
SKAMo-2: the Real-life Test of Continuous Photoacoustic Signal by Neogly in Patients With Type I Diabetes
Official Title
SKAMo-2: the Real-life Test of Continuous Photoacoustic Signal by Neogly in Patients With Type I Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 6, 2023 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
October 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eclypia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Wearing the non-invasive continous monitoring device during one week to record photoacoustic signal
Arm Type
Experimental
Arm Description
Wearing the non-invasive continous monitoring device during one week to record photoacoustic signal
Intervention Type
Device
Intervention Name(s)
Non-invasive continuous monitoring device to record photoacoustic signal
Intervention Description
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.
Primary Outcome Measure Information:
Title
Value of absolute photoacoustic signal on the participant arm
Description
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.
Time Frame
around one week (7 to 9 days)
Secondary Outcome Measure Information:
Title
assess the safety by the general clinical evaluation (normal, abnormal, abnormal not clinically significant)
Description
baseline (V1) and after the device wearing (V2)
Time Frame
around one week (7 to 9 days)
Title
assess the safety by number/class of adverse events
Description
definitions of AE from European Medical Device Regulation 2017/745
Time Frame
during one week (7 to 9 days)
Title
assess the tolerability of the investigational device by a usability questionnaire
Description
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
Time Frame
around one week (7 to 9 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eclypia
Phone
33476767383
Email
contact@eclypia.com
Facility Information:
Facility Name
CHU Grenoble Alpes
City
Grenoble
ZIP/Postal Code
38043
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Centre d'investigation clinique Centre d'investigation clinique
Phone
334.76.767.575
Email
CIC@chu-grenoble.fr
First Name & Middle Initial & Last Name & Degree
Pierre-Yves Pr BENHAMOU, principal investigator
12. IPD Sharing Statement
Learn more about this trial
SKAMo-2: the Real-life Test of Continuous Photoacoustic Signal by Neogly in Patients With Type I Diabetes
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