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

Not Applicable

Completed

• Conditions: Type 1 Diabetes Mellitus; Type 1 Diabetes Mellitus with Hypoglycemia; Type 1 Diabetes Mellitus with Hyperglycemia
• Interventions: Device: Lab Demo 1.0

• Registration Number: NCT06097689
• Lead Sponsor: Liom Health AG

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-10
• Study First Submitted QC: 2023-10-23
• Study First Posted: 2023-10-24
• Study Start: 2023-11-24
• Primary Completion: 2024-05-16
• Study Completion: 2024-05-16
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-27
• Last Update Posted: 2024-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Investigational arm	Lab Demo 1.0	Induction of different glycaemia states via intravenous regular insulin and intravenous glucose administration and measurements of transcutaneous spectral data with the investigational device and reference blood glucose values.

Primary Outcome Measures

Name	Time	Method
Changes in spectral fingerprints measured by the Lab Demo 1.0 at fluctuations of venous blood glucose levels	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 Outcome Measures

Name	Time	Method
Blood glucose levels	During the study procedure (6 to 8 hours)	Blood glucose levels at the time of changes in spectral fingerprints measured by the Lab Demo 1.0
Spectral fingerprints measured by the Lab Demo 1.0	The data is collected during the study procedure (6 to 8 hours)	This secondary objective consists of describing the spectral fingerprints at different blood glucose levels (defined by both venous blood glucose and interstitial fluid glucose)
Heart rate	During the study procedure (6 to 8 hours)	Heart rate at the time of changes in spectral fingerprints measured by the Lab Demo 1.0
Oxygen saturation	During the study procedure (6 to 8 hours)	Oxygen saturation at the time of changes in spectral fingerprints measured by the Lab Demo 1.0
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)	The secondary outcome is to assess the feasibility/capacity of the prototype device to measure changes in spectral fingerprints at fluctuations of interstitial fluid glucose levels in ranges of hypoglycaemic and hyperglycaemic states.

Trial Locations

Locations (1)

Markus Laimer; 🇨🇭 Berne, Switzerland