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Completed

NCT Number: NCT05771090

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

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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hypoglycemia Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Bern, 3010, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sokru device

Device

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

Primary outcomes

  1. Characteristics of volatile organic compound (VOC) signals measured by the Sokru device

    Time frame: 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 outcomes

  1. Volatile Organic Compound Signals

    Time frame: During the study procedure (approximately 5 hours)

    VOC signals measured by the Sokru device at different blood glucose levels

  2. Blood glucose concentration

    Time frame: 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

  3. Time of onset of subjective symptoms of hypoglycemia

    Time frame: During the study procedure (approximately 5 hours)

    Self-reported onset of subjective symptoms of hypoglycemia

  4. Heart rate

    Time frame: During the study procedure (approximately 5 hours)

    Heart rate is measured with a Mindray device

  5. Oxygen saturation

    Time frame: During the study procedure (approximately 5 hours)

    Oxygen saturation is measured with a Mindray device

Sponsors and collaborators

Lead sponsor

DCB Research AG

Other

Collaborators

  • Insel Gruppe AG, University Hospital Bern

Registry information

Official study title

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

Acronym: VAARA

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 16, 2023
Registry last updated
Jun 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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