Clinical trial NCT06097689: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Type 1 Diabetes Mellitus with Hypoglycemia
Type 1 Diabetes Mellitus with Hyperglycemia
Keywords: Hypoglycemia
Hyperglycemia
Diabetes
Transcutaneous
Spectral fingerprint
Noninvasive
Lead sponsor: Liom Health AG
Sponsor class: INDUSTRY
Collaborators: name: DCB Research AG
First posted: 2023-10-24
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The primary aim of this study is to assess the feasibility of the Lab demo 1.0 and associated computational models to detect and track glucose changes noninvasively and transcutaneously in defined and dynamic states of glycemia.


Eligibility criteria: 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

Primary outcomes:
measure: Changes in spectral fingerprints measured by the Lab Demo 1.0 at fluctuations of venous blood glucose levels
timeFrame: The data is collected during the study procedure (6 to 8 hours)
Secondary outcomes:
measure: Changes in spectral fingerprints measured by the Lab Demo 1.0 at fluctuations of interstitial fluid glucose levels
timeFrame: The data is collected during the study procedure (6 to 8 hours)
measure: Spectral fingerprints measured by the Lab Demo 1.0
timeFrame: The data is collected during the study procedure (6 to 8 hours)
measure: Blood glucose levels
timeFrame: During the study procedure (6 to 8 hours)
measure: Heart rate
timeFrame: During the study procedure (6 to 8 hours)
measure: Oxygen saturation
timeFrame: During the study procedure (6 to 8 hours)
Other outcomes:
Locations:
city: Berne
country: Switzerland
facility: Markus Laimer
Study officials:
affiliation: Liom Health AG
name: Fabien Rebeaud, PhD
role: STUDY_DIRECTOR
affiliation: University Department of Diabetology, Endocrinology, Nutritional Medicine &amp; Metabolism (UDEM), Inselspital, Bern University Hospital
name: Markus Laimer, Prof Dr med
role: PRINCIPAL_INVESTIGATOR
References: