The HypoVoice Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-11

Study Completion Date

2023-01-31

Brief Summary

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The HypoVoice study aims at identifying potential vocal biomarkers associated with hypoglycemia to pave the way towards a voice-based hypoglycemia detection approach.

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Detailed Description

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While hypoglycemia has been widely studied in medical research, studies assessing vocal changes associated with this state are limited. This study aims at collecting a data set labelled with the gold standard (blood glucose) to provide a solid basis for the identification of vocal biomarkers using machine learning. Additionally, physiological data are collected using wearable sensors to assess whether additional integration of vital signs (e.g. heart rate) enhances the performance of hypoglycemia detection.

Conditions

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Diabetes Mellitus Hypoglycemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Participants are aware that hypoglycemia will be induced during the study but they are blinded to their blood glucose levels throughout the hypoglycemia procedure.

Study Groups

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Controlled hypoglycemic state

Group Type OTHER

Controlled hypoglycemic state

Intervention Type OTHER

Voice sampling is performed in different glycemic states (euglycemia and hypoglycemia).

Interventions

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Controlled hypoglycemic state

Voice sampling is performed in different glycemic states (euglycemia and hypoglycemia).

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Written informed consent
* Type 1 Diabetes mellitus as defined by WHO for at least 6 months
* Aged 18 - 60 years
* HbA1c ≤9.0 %
* Functional insulin treatment with good knowledge of insulin self-management
* Native language German or Swiss German
* Use of continuous glucose monitoring (CGM) or flash glucose monitoring (FGM)

Exclusion Criteria

* Incapacity to give informed consent
* Contraindications to insulin aspart (NovoRapid®)
* Total daily insulin dose \>2 IU/kg/day
* Pregnancy, breast-feeding or lack of safe contraception
* Active heart, lung, liver, gastrointestinal, renal or psychiatric disease
* Pacemaker or implantable cardioverter defibrillator (ICD)
* Epilepsy or history of seizure
* Chronic neurological or ear-nose-and-throat (ENT) disease influencing voice or history of voice disorder
* Illiteracy or dyslexia
* Active smoking
* Active drug or alcohol abuse
* Medication known to interfere with voice or to induce listlessness (e.g. opioids, benzodiazepines, etc.)

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No