Investigation of Hyposafe H02 Device in Patients With Type 1 Diabetes
NCT05495386 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL
Last updated 2023-12-22
Summary
This clinical study is designed to collect data for further development of a hypoglycaemia notification algorithm. In addition, information regarding safety will be collected and analysed.
Conditions
Interventions
- DEVICE
-
Hyposafe hypoglycaemia notification device (H02)
The H02 device consists of two parts: 1. An implantable part which records the EEG signal and transmits the signal wirelessly to the external device. 2. The external device receiving signals and storing data from the implant.
Sponsors & Collaborators
-
UNEEG Medical A/S
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-09-01
- Primary Completion
- 2024-01-01
- Completion
- 2024-03-01
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