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

First Clinical Evaluation of a Novel Glucose Non-invasive Sensor Technology in Patients With Type 1 Diabetes: a Single-arm Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Device: Sokru device

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stefanie Hossmann, MSc; Phone Number: +41794217376; Email: stefanie.hossmann@dcberne.com
• Study Contact Backup: Name: Constance Bischoff; Email: constance.bischoff@dcberne.com

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Universitätsklinik für Diabetologie, Endokrinologie, Ernährungsmedizin & Metabolismus (UDEM) Inselspital, Universitätsspital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study arm; Participants in the study arm will undergo the study procedure which are different induced glycaemic states.	Device: Sokru device; Different induced glycaemic states in people living with diabetes (PwD).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Characteristics of volatile organic compound (VOC) signals measured by the Sokru device	The primary outcome are changes in VOC signals measured by the Sokru at low glucose levels (below 3.0 -3.9 mmol/L) or during the time when the blood glucose level is decreasing (from 10 and 3.9 mmol/L).	During the study procedure (approximately 5 hours)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volatile Organic Compound Signals	VOC signals measured by the Sokru device at different blood glucose levels	During the study procedure (approximately 5 hours)
Blood glucose concentration	Blood glucose levels are measured with the continuous glucose measurement system and in the venous blood at the time of the appearance of VOC signal peaks or drops	During the study procedure (approximately 5 hours)
Time of onset of subjective symptoms of hypoglycemia	Self-reported onset of subjective symptoms of hypoglycemia	During the study procedure (approximately 5 hours)
Heart rate	Heart rate is measured with a Mindray device	During the study procedure (approximately 5 hours)
Oxygen saturation	Oxygen saturation is measured with a Mindray device	During the study procedure (approximately 5 hours)

Collaborators and Investigators

• Sponsor: DCB Research AG
• Collaborators: Insel Gruppe AG, University Hospital Bern
• Investigators: Study Chair: Derek Brandt, DCB Research AG

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Actual): June 16, 2023
• Study Completion (Actual): June 16, 2023

Study Registration Dates

• First Submitted: February 28, 2023
• First Submitted That Met QC Criteria: March 15, 2023
• First Posted (Actual): March 16, 2023

Study Record Updates

• Last Update Posted (Actual): June 29, 2023
• Last Update Submitted That Met QC Criteria: June 28, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Volatile Organic Compounds; Hypoglycaemia
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: VAARA study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No