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

NCT ID: NCT06097689

Last Updated: 2024-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-24
• Study Completion Date: 2024-05-16

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Lab Demo 1.0

Intervention Type: 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).

Interventions

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).

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

DCB Research AG

OTHER

Sponsor Role: collaborator

Liom Health AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fabien Rebeaud, PhD

Role: STUDY_DIRECTOR

Liom Health AG

Markus Laimer, Prof Dr med

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Markus Laimer

Bern, Canton of Bern, Switzerland

Countries

Switzerland

Other Identifiers

SPN-005

Identifier Type: -

Identifier Source: org_study_id