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
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This is a single-centre, multiple cohort, open study.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• 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 insulin and/or oral antidiabetic drugs (OADs; type 2 only), multiple dosing insulin therapy (MDI), continuous subcutaneous insulin infusion (CSII) or a hybrid closed loop system.
Locations
Other Locations
Germany
Profil for Stoffwechselforschung GmbH
RECRUITING
Neuss
Contact Information
Primary
Banu Eyueboglu Seitz, PhD
bes@liom.com
0041 41 552 00 59
Backup
Fabien Rebeaud, PhD
fr@liom.com
0041 41 552 00 59
Time Frame
Start Date: 2024-02-23
Estimated Completion Date: 2025-07-31
Participants
Target number of participants: 80
Treatments
Experimental: Interventional arm
Induction of hyperglycaemia and hypoglcemia states and measurements of transcutaneous spectral data with the investigational device and reference blood glucose values measured by Super GL and Freestyle Libre 3.
Related Therapeutic Areas
Sponsors
Collaborators: Profil Institut für Stoffwechselforschung GmbH
Leads: Liom Health AG