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

Liom Health AG1 site in 1 country21 target enrollmentNovember 24, 2023

ConditionsType 1 Diabetes Mellitus Type 1 Diabetes Mellitus with Hypoglycemia Type 1 Diabetes Mellitus with Hyperglycemia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Type 1 Diabetes Mellitus
Sponsor: Liom Health AG
Enrollment: 21
Locations: 1
Primary Endpoint: Changes in spectral fingerprints measured by the Lab Demo 1.0 at fluctuations of venous blood glucose levels
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 24, 2023

End Date

May 16, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Liom Health AG

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

Changes in spectral fingerprints measured by the Lab Demo 1.0 at fluctuations of venous blood glucose levels

Time Frame: The data is collected during the study procedure (6 to 8 hours)

The primary outcome is to assess the feasibility/capacity of the prototype device to measure changes in spectral fingerprints at fluctuations of venous blood glucose levels in ranges of hypoglycaemic and hyperglycaemic states.

Secondary Outcomes

Blood glucose levels(During the study procedure (6 to 8 hours))
Spectral fingerprints measured by the Lab Demo 1.0(The data is collected during the study procedure (6 to 8 hours))
Heart rate(During the study procedure (6 to 8 hours))
Oxygen saturation(During the study procedure (6 to 8 hours))
Changes in spectral fingerprints measured by the Lab Demo 1.0 at fluctuations of interstitial fluid glucose levels(The data is collected during the study procedure (6 to 8 hours))