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

NCT06097689 | Completed

• 1 other identifier: SPN-005
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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)

• Spectral fingerprints measured by the Lab Demo 1.0

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

• Blood glucose levels

  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)

Study Arms (1)

Investigational arm

EXPERIMENTAL

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

Interventions

Lab Demo 1.0 DEVICE

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).

Investigational arm

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• nformed Consent signed by the subject
• Male and female subjects 18 - 60 years of age (inclusive)
• Skin colour Type I, II, or III according to Fitzpatrick Scale (see Appendix 1)
• Type 1 diabetes diagnosed \> 12 months ago
• Intensified insulin therapy scheme using multiple daily injection (MDI) or continuous subcutaneous insulin infusion (CSII) for more than 6 months
• BMI between 18.5 and 28.0 kg/m2
• Using a CGM/FGM system (Freestyle Libre2, Freestyle Libre3, Dexcom G6 or Dexcom G7)
• Willingness to follow the study procedure

You may not qualify if:

• In female subjects: pregnancy or breastfeeding period (self-reported)
• 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
• History of cardiovascular diseases
• Irregular 12-lead ECG upon investigator's judgement
• Medical history of epilepsy or other neurological disease associated with seizure events
• 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
• Known sensitivity to medical grade adhesives or other skin-related complications, which might influence the outcome
• Not able to understand, write or read German
• Participation in another investigation with an investigational drug within the 30 days preceding and during the present investigation
• Enrolment of the PI, his/her family members, employees and other dependent persons

Sponsors & Collaborators

• Liom Health AG: lead
• DCB Research AG: collaborator

Study Sites (1)

Markus Laimer

Bern, Canton of Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hypoglycemia; Hyperglycemia; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Fabien Rebeaud, PhD

  Liom Health AG

  STUDY DIRECTOR

• Markus Laimer, Prof Dr med

  University Department of Diabetology, Endocrinology, Nutritional Medicine & Metabolism (UDEM), Inselspital, Bern University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2023
• First Posted: October 24, 2023
• Study Start: November 24, 2023
• Primary Completion: May 16, 2024
• Study Completion: May 16, 2024
• Last Updated: October 1, 2024

Record last verified: 2024-09

Locations

CH (1)