Clinical trial NCT05569876: The HypoVoice Study
Official title: Vocal Biomarkers for the Detection and Prevention of Hypoglycemia (HypoVoice)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Hypoglycemia
Keywords: Hypoglycemia
Voice
Speech
Detection
Artificial intelligence (AI)
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: Idiap Research Institute
name: CSEM Centre Suisse d'Electronique et de Microtechnique SA
name: Ludwig-Maximilians - University of Munich
First posted: 2022-10-06
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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.)

Primary outcomes:
measure: Diagnostic accuracy of the HypoVoice approach to detect hypoglycemia based on voice data quantified as area under the receiver operating characteristic curve (AUROC)
timeFrame: 4 hours
Secondary outcomes:
measure: 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)
timeFrame: 4 hours
measure: Voice parameters indicative of hypoglycemia
timeFrame: 4 hours
measure: Physiological parameters indicative of hypoglycemia
timeFrame: 4 hours
Other outcomes:
measure: Change in hypoglycemic symptoms across the glycemic trajectory
timeFrame: 4 hours
measure: Change in cognitive performance across the glycemic trajectory.
timeFrame: 4 hours
measure: Change in cognitive performance across the glycemic trajectory.
timeFrame: 4 hours
Locations:
city: Bern
country: Switzerland
facility: Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism
Study officials:
affiliation: Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Bern, Switzerland
name: Christoph Stettler, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References: