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

Not Applicable

Completed

• Conditions: Diabetes Mellitus
• Interventions: Device: Sokru device

• Registration Number: NCT05771090
• Lead Sponsor: DCB Research AG

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2023-02-28
• Study First Submitted QC: 2023-03-15
• Study First Posted: 2023-03-16
• Study Start: 2023-04-01
• Status Verified: 2023-06
• Primary Completion: 2023-06-16
• Study Completion: 2023-06-16
• Last Update Submitted: 2023-06-28
• Last Update Posted: 2023-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study arm	Sokru device	Participants in the study arm will undergo the study procedure which are different induced glycaemic states.

Primary Outcome Measures

Name	Time	Method
Characteristics of volatile organic compound (VOC) signals measured by the Sokru device	During the study procedure (approximately 5 hours)	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).

Secondary Outcome Measures

Name	Time	Method
Blood glucose concentration	During the study procedure (approximately 5 hours)	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
Heart rate	During the study procedure (approximately 5 hours)	Heart rate is measured with a Mindray device
Oxygen saturation	During the study procedure (approximately 5 hours)	Oxygen saturation is measured with a Mindray device
Volatile Organic Compound Signals	During the study procedure (approximately 5 hours)	VOC signals measured by the Sokru device at different blood glucose levels
Time of onset of subjective symptoms of hypoglycemia	During the study procedure (approximately 5 hours)	Self-reported onset of subjective symptoms of hypoglycemia

Trial Locations

Locations (1)

Universitätsklinik für Diabetologie, Endokrinologie, Ernährungsmedizin & Metabolismus (UDEM) Inselspital, Universitätsspital; 🇨🇭 Bern, Switzerland