SPN-005 - A pilot study to evaluate the feasibility of a novel non-invasive technology for measuring fluctuating blood glucose levels in adults with type 1 diabetes: A single-arm pilot study

Switzerland (ICTRP)

ID di studio ICTRP
NCT06097689 (ICTRP)

Titolo ufficiale (approvato dal comitato etico)
A Pilot Study to Assess the Feasibility of a Novel Non-Invasive Technology to Measure Glucose Dynamics in Adults Living with Type 1 Diabetes Mellitus: A Single-Arm Pilot Study (BASEC)

Titolo accademico
A Pilot Study to Assess the Feasibility of a Novel Non-Invasive Technology to Measure Glucose Dynamics in Adults Living with Type 1 Diabetes Mellitus: a Single-Arm Pilot Study (ICTRP)

Titolo pubblico
A Pilot Study to Assess the Feasibility of a Novel Non-invasive Technology to Measure Changing Blood Glucose Levels in Adults with Type-1 Diabetes Mellitus (ICTRP)

Malattie studiate
Type 1 Diabetes Mellitus;Type 1 Diabetes Mellitus with Hypoglycemia;Type 1 Diabetes Mellitus with Hyperglycemia (ICTRP)

Intervento studiato
Device: Lab Demo 1.0 (ICTRP)

Tipo di studio
Interventional (ICTRP)

Disegno dello studio
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Device Feasibility. Masking: None (Open Label). (ICTRP)

Criteri di inclusione/esclusione
Gender: All
Maximum age: 60 Years
Minimum age: 18 Years
Inclusion Criteria:

- 1.1nformed Consent signed by the subject

- 1.2 Male and female subjects 18 - 60 years of age (inclusive)

- 1.3 Skin colour Type I, II, or III according to Fitzpatrick Scale (see Appendix 1)

- 1.4 Type 1 diabetes diagnosed > 12 months ago

- 1.5 Intensified insulin therapy scheme using multiple daily injection (MDI) or
continuous subcutaneous insulin infusion (CSII) for more than 6 months

- 1.6 BMI between 18.5 and 28.0 kg/m2

- 1.7 Using a CGM/FGM system (Freestyle Libre2, Freestyle Libre3, Dexcom G6 or Dexcom
G7)

- 1.8 Willingness to follow the study procedure

Exclusion Criteria:

- 2.1 In female subjects: pregnancy or breastfeeding period (self-reported)

- 2.2 HbA1c of > 9.0% (based on last measurement by treating physician but not older
than 120 days) Note: To be repeated at the study site if measurement is older than
120 days or not available

- 2.3 History of cardiovascular diseases

- 2.4 Irregular 12-lead ECG upon investigator's judgement

- 2.5 Medical history of epilepsy or other neurological disease associated with
seizure events

- 2.6 Atypical skin condition (e.g., Hyperkeratosis, Hyperpigmentation) or presence of
tattoos or scars in the measurement area (wrist) that could impair validity of
measurement upon investigator's judgement

- 2.7 Known sensitivity to medical grade adhesives or other skin-related
complications, which might influence the outcome

- 2.8 Not able to understand, write or read German

- 2.9 Participation in another investigation with an investigational drug within the
30 days preceding and during the present investigation

- 2.10 Enrolment of the PI, his/her family members, employees and other dependent
persons (ICTRP)

non disponibile

Endpoint primari e secondari
Changes in spectral fingerprints measured by the Lab Demo 1.0 at fluctuations of venous blood glucose levels (ICTRP)

Changes in spectral fingerprints measured by the Lab Demo 1.0 at fluctuations of interstitial fluid glucose levels;Spectral fingerprints measured by the Lab Demo 1.0;Blood glucose levels;Heart rate;Oxygen saturation (ICTRP)

Data di registrazione
10.10.2023 (ICTRP)

Inclusione del primo partecipante
non disponibile

Sponsor secondari
DCB Research AG (ICTRP)

Contatti aggiuntivi
Fabien Rebeaud, PhD;Markus Laimer, Prof Dr med, Liom Health AG,University Department of Diabetology, Endocrinology, Nutritional Medicine & Metabolism (UDEM), Inselspital, Bern University Hospital (ICTRP)

ID secondari
SPN-005 (ICTRP)

Risultati-Dati individuali dei partecipanti
non disponibile

Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT06097689 (ICTRP)