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

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

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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes Mellitus; Type 1 Diabetes Mellitus with Hypoglycemia; Type 1 Diabetes Mellitus with Hyperglycemia
• Intervention / Treatment: Device: Lab Demo 1.0

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Berne, Switzerland, 3010
    • Markus Laimer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Investigational arm; 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; 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).

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Liom Health AG
• Collaborators: DCB Research AG
• Investigators: Principal Investigator: Markus Laimer, Prof Dr med, University Department of Diabetology, Endocrinology, Nutritional Medicine & Metabolism (UDEM), Inselspital, Bern University Hospital; Study Director: Fabien Rebeaud, PhD, Liom Health AG

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2023
• Primary Completion (Actual): May 16, 2024
• Study Completion (Actual): May 16, 2024

Study Registration Dates

• First Submitted: October 10, 2023
• First Submitted That Met QC Criteria: October 23, 2023
• First Posted (Actual): October 24, 2023

Study Record Updates

• Last Update Posted (Actual): October 1, 2024
• Last Update Submitted That Met QC Criteria: September 27, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Diabetes; Hypoglycemia; Hyperglycemia; Noninvasive; Transcutaneous; Spectral fingerprint
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Hyperglycemia; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemia
• Other Study ID Numbers: SPN-005

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No