Investigation of Hyposafe H02 Device in Patients With Type 1 Diabetes

NCT05495386 | Withdrawn

• 1 other identifier: U010
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Type 1 Diabetes

Outcome Measures

Primary Outcomes (3)

• To collect electrocardiogram (EEG) data to develop a hypoglycaemia notification algorithm.

  Recording of EEG characteristic hypoglycaemic related changes and EEG during normoglycemia measured as number of hours EEG data from each participant.

  7-8 months

• To collect self-measured blood glucose (SMBG) data to develop a hypoglycaemia notification algorithm.

  Number SMBG measurements below 3 mmol/L glucose per participant

  7-8 months

• To collect continuous glucose monitoring (CGM) data to develop a hypoglycaemia notification algorithm.

  Number of CGM values below 3 mmol/L glucose per participant

  7-8 months

Secondary Outcomes (3)

• To evaluate the safety of H02 in participants with type 1 diabetes.

  7-8 months

• To evaluate the performance of H02 in participants with type 1 diabetes.

  7-8 months

• To evaluate the surgeon satisfaction of H02 in participants with type 1 diabetes.

  0 and 7-8 months

Study Arms (1)

Hyposafe H02 Device

EXPERIMENTAL

Hyposafe H02 Device will be used in the study

Device: Hyposafe hypoglycaemia notification device (H02)

Interventions

Hyposafe hypoglycaemia notification device (H02) DEVICE

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.

Also known as: H02

Hyposafe H02 Device

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent
• Age 18-70 years
• Impaired awareness, i.e., defined as unaware by the Pedersen-Bjergaard scale and history of at least one severe hypoglycaemia within the preceding year
• Use of continuous glucose monitoring at study start

You may not qualify if:

• High risk of surgical complications
• Involved in therapies with medical devices that deliver electrical energy into the area around the implant
• Infection at the site of device implantation
• Contraindications to the local anaesthetic used during implantation and explantation
• Have cochlear implant(s)
• Subject is scheduled to undergo MRI scan, ultrasound, radiation, or electrical current induced close to the implant, within 6 months after enrolment
• Severe cardiac disease
• History of stroke/ cerebral haemorrhage and any other structural cerebral disease
• Active cancer or cancer diagnosis within the past 5 years

Sponsors & Collaborators

• UNEEG Medical A/S: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2022
• First Posted: August 10, 2022
• Study Start: September 1, 2022
• Primary Completion: January 1, 2024
• Study Completion: March 1, 2024
• Last Updated: December 22, 2023

Record last verified: 2023-12