The HypoVoice Study

Study Overview
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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.

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.

Official Title
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Vocal Biomarkers for the Detection and Prevention of Hypoglycemia (HypoVoice)

Conditions
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Diabetes Mellitus, Hypoglycemia

Intervention / Treatment
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* Other: Controlled hypoglycemic state


Participation Criteria
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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.)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Controlled hypoglycemic state<br> | Other: Controlled hypoglycemic state<br>* Voice sampling is performed in different glycemic states (euglycemia and hypoglycemia).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy of the HypoVoice approach to detect hypoglycemia based on voice data quantified as area under the receiver operating characteristic curve (AUROC) | Voice data will be collected in eu- and hypoglycemia | 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy of the HypoVoice approach to detect hypoglycemia based on voice and physiological data quantified as area under the receiver operating characteristic curve (AUROC) | Voice and physiological data will be collected in eu- and hypoglycemia | 4 hours | 
| Voice parameters indicative of hypoglycemia | Explainable AI methods will be used to identify voice parameters indicative of hypoglycemia | 4 hours | 
| Physiological parameters indicative of hypoglycemia | Explainable AI methods will be used to identify physiological parameters indicative of hypoglycemia | 4 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypoglycemia, Voice, Speech, Detection, Artificial intelligence (AI)