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

Type 1 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06097689
• Other study ID #: SPN-005
• Status: Recruiting
• Phase: N/A
• Start date: November 24, 2023
• Est. completion date: April 30, 2024

Study information

• Verified date: October 2023
• Source: Spiden AG
• Contact: Marie-Aline Gérard, PhD
• Phone: 0782049811
• Email: marie-aline.gerard[@]dcberne.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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).

Locations

Country	Name	City	State
Switzerland	Markus Laimer	Berne

Sponsors (2)

Lead Sponsor	Collaborator
Spiden AG	DCB Research AG

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)