First Clinical Evaluation of a Novel Glucose Non-invasive Sensor Technology in Patients With Type 1 Diabetes

NCT ID: NCT05771090

Last Updated: 2023-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2023-06-16

Brief Summary

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The primary aim of this clinical study is to find signal characteristics of VOCs detected by Sokru device during fasting, insulin injection and after glucose intake and to find the association with blood glucose variation in variant states of glycemia and hypoglycemia.

Detailed Description

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Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Sokru device, prototype
Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Study arm

Participants in the study arm will undergo the study procedure which are different induced glycaemic states.

Group Type EXPERIMENTAL

Sokru device

Intervention Type DEVICE

Different induced glycaemic states in people living with diabetes (PwD).

Interventions

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Sokru device

Different induced glycaemic states in people living with diabetes (PwD).

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Written informed consent
* T1D with MDI or CSII therapy \>1 year
* Age 18 - 50 (inclusive)
* Caucasian ethnicity
* BMI between 18.5 and 24.9 kg/m2 (inclusive)
* Usage of a continuous glucose monitoring (CGM)

Exclusion Criteria

* Pregnancy or breastfeeding
* History of cardiovascular diseases
* Diabetes-related comorbidities
* HbA1c \>9 %
* Epilepsy
* Known sensitivity to medical grade adhesives or other skin-related complications, which might influence the outcome
* Known sensitivity to Latex
* Participation in another investigation with an investigational drug within the 30 days preceding and during the present investigation
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role collaborator

DCB Research AG

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Derek Brandt

Role: STUDY_CHAIR

DCB Research AG

Locations

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Universitätsklinik für Diabetologie, Endokrinologie, Ernährungsmedizin & Metabolismus (UDEM) Inselspital, Universitätsspital

Bern, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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VAARA study

Identifier Type: -

Identifier Source: org_study_id

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