NCT05771090

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable diabetes-mellitus

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 16, 2023

Completed
16 days until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 16, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2023

Completed
Last Updated

June 29, 2023

Status Verified

June 1, 2023

Enrollment Period

3 months

First QC Date

February 28, 2023

Last Update Submit

June 28, 2023

Conditions

Diabetes Mellitus

Keywords

Volatile Organic CompoundsHypoglycaemia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Volatile Organic Compound Signals

    During the study procedure (approximately 5 hours)

  • Blood glucose concentration

    During the study procedure (approximately 5 hours)

  • Time of onset of subjective symptoms of hypoglycemia

    During the study procedure (approximately 5 hours)

  • Heart rate

    During the study procedure (approximately 5 hours)

  • Oxygen saturation

    During the study procedure (approximately 5 hours)

Study Arms (1)

Study arm

EXPERIMENTAL

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

Device: Sokru device

Interventions

Sokru deviceDEVICE

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

Study arm

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Diabetes MellitusHypoglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Derek Brandt

    DCB Research AG

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Model Details: Sokru device, prototype
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2023

First Posted

March 16, 2023

Study Start

April 1, 2023

Primary Completion

June 16, 2023

Study Completion

June 16, 2023

Last Updated

June 29, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)