The HypoVoice Study

Insel Gruppe AG, University Hospital Bern7 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Diabetes Mellitus Hypoglycemia

Interventions

Controlled hypoglycemic stateOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.)

Locations (1)

Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism

Bern, Switzerland

Outcomes

Primary Outcomes

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

Time frame: 4 hours

Secondary Outcomes

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

Time frame: 4 hours

Voice parameters indicative of hypoglycemia

Explainable AI methods will be used to identify voice parameters indicative of hypoglycemia

Time frame: 4 hours

Physiological parameters indicative of hypoglycemia

Explainable AI methods will be used to identify physiological parameters indicative of hypoglycemia

Time frame: 4 hours

Data from ClinicalTrials.gov

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