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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Type 1 Diabetes Mellitus, Type 1 Diabetes Mellitus With Hypoglycemia, Type 1 Diabetes Mellitus With Hyperglycemia

Intervention / Treatment
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* Device: Lab Demo 1.0


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational arm<br>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. | Device: Lab Demo 1.0<br>* Lowering of the participants blood glucose with the application of insulin to induce hypoglycaemia, followed by the application of glucose to induce hyperglycaemia and finally insulin to restore euglycemia. During the different glycaemia states, transcutaneous spectral data are collected continuously with the device and paired with reference measurements (venous blood and interstitial fluid).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in spectral fingerprints measured by the Lab Demo 1.0 at fluctuations of venous blood glucose levels | 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. | The data is collected during the study procedure (6 to 8 hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in spectral fingerprints measured by the Lab Demo 1.0 at fluctuations of interstitial fluid glucose levels | 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. | The data is collected during the study procedure (6 to 8 hours) | 
| Spectral fingerprints measured by the Lab Demo 1.0 | This secondary objective consists of describing the spectral fingerprints at different blood glucose levels (defined by both venous blood glucose and interstitial fluid glucose) | The data is collected during the study procedure (6 to 8 hours) | 
| Blood glucose levels | Blood glucose levels at the time of changes in spectral fingerprints measured by the Lab Demo 1.0 | During the study procedure (6 to 8 hours) | 
| Heart rate | Heart rate at the time of changes in spectral fingerprints measured by the Lab Demo 1.0 | During the study procedure (6 to 8 hours) | 
| Oxygen saturation | Oxygen saturation at the time of changes in spectral fingerprints measured by the Lab Demo 1.0 | During the study procedure (6 to 8 hours) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypoglycemia, Hyperglycemia, Diabetes, Transcutaneous, Spectral fingerprint, Noninvasive