Trials / Completed
CompletedNCT06097689
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
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 21 (actual)
- Sponsor
- Liom Health AG · Industry
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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). |
Timeline
- Start date
- 2023-11-24
- Primary completion
- 2024-05-16
- Completion
- 2024-05-16
- First posted
- 2023-10-24
- Last updated
- 2024-10-01
Locations
1 site across 1 country: Switzerland
Source: ClinicalTrials.gov record NCT06097689. Inclusion in this directory is not an endorsement.