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

DCB Research

Status: Completed

Conditions: Diabetes Mellitus

Treatments: Device: Sokru device

Study type: Interventional

Funder types: Other

Identifiers

NCT05771090

VAARA study

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Study arm

Experimental group

Description:

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

Treatment:

Device: Sokru device