Spiden Non-invasive Continuous Glucose Monitor "Clinical Demo" (niCGM)

Type 1 Diabetes Clinical Trial

Official title:

An Exploratory Study to Assess the Accuracy in the Normo- to Hyperglycemic Range of the Spiden Non-invasive Continuous Glucose Monitor "Clinical Demo" (niCGM), in Trial Participants With Type 1 or Type 2 Diabetes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06272136
• Other study ID #: SPN-007
• Status: Recruiting
• Phase: N/A
• Start date: February 23, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Spiden AG
• Contact: Banu Eyueboglu Seitz, PhD
• Phone: 0041 41 552 00 59
• Email: bes[@]spiden.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a single-centre, multiple sequential-cohort, open study.

Description:

The study will include 3 cohorts. After each cohort, optimisation of the Spiden Clinical Demo 2.0 system and machine learning models may be pursued before the next cohort is started. Trial participants with type 1 or type 2 diabetes mellitus.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Male or female trial participant with clinically diagnosed type 1 or type 2 diabetes for at least 1 year.
• Age between 18 and 65 years, both inclusive.
• Treated with basal insulin or basal insulin and oral antidiabetic drugs (OADs; type 2 only), multiple dosing insulin therapy (MDI), continuous subcutaneous insulin infusion (CSII) or a hybrid closed loop system.

Exclusion Criteria:

• Known or suspected hypersensitivity to any of the components of the Spiden Clinical Demo 2.0.
• Trial participant with any injury, infection, atypical skin condition (e.g., hyperkeratosis, hyperpigmentation) of or tattoo on the wrists.
• Presence or history of a cardiovascular disease including stable and unstable angina pectoris, myocardial infarction, transient ischaemic attack, stroke, cardiac decompensation, clinically significant arrhythmias or clinically significant conduction disorders.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 1 Diabetes

Intervention

Device:
• Clinical Demo 2.0
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
Germany	Profil for Stoffwechselforschung GmbH	Neuss	Nordrhein-Westfallen

Sponsors (2)

Lead Sponsor	Collaborator
Spiden AG	Profil Institut für Stoffwechselforschung GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose changes will be measured noninvasively and transcutaneously in dynamic states of glycaemia	Spectroscopic research platform and associated computational models will be used to detect and track glucose changes noninvasively and transcutaneously in dynamic states of glycaemia	The data is collected during the study procedure (up to 5 hours)