Testing a non-invasive device for monitoring blood sugar in type I diabetes patients

SKAMo-2: the Real-life Test of Continuous Photoacoustic Signal by Neogly in Patients With Type I Diabetes

This study tests a new non-invasive device that continuously checks blood sugar levels in people with type I diabetes to see if it works better than traditional methods.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years to 50 Years
• Sex: All
• Sponsor: Eclypia (industry)
• Locations: 1 site (Grenoble)
• Trial ID: NCT06035367 on ClinicalTrials.gov

What this trial studies

This study evaluates a new non-invasive medical device designed to continuously monitor blood glucose levels in patients with type I diabetes using a photoacoustic signal. Participants will wear the device for one week while also using a FreeStyle Libre continuous glucose monitor and insulin delivery methods. The goal is to determine if the signals collected by this investigational device are relevant and can be utilized effectively for glucose monitoring. The study aims to provide a solution to the current invasive methods of blood sugar monitoring.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 50 with type I diabetes who are currently using a FreeStyle Libre CGM and insulin delivery methods.

Not a fit: Patients with skin diseases, serious health conditions, or those with a BMI over 30 may not benefit from this study.

Why it matters

Potential benefit: If successful, this device could significantly improve the quality of life for patients with type I diabetes by providing a painless and continuous method for blood glucose monitoring.

How similar studies have performed: While non-invasive glucose monitoring is a high-demand area, this specific approach using photoacoustic signals is novel and has not been extensively tested in previous studies.

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

Where this trial is running

Grenoble

• CHU Grenoble Alpes — Grenoble, France (RECRUITING)

Study contacts

• Study coordinator: Eclypia

Conditions: Diabetes