The HypoVoice Study (HypoVoice)

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

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

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus; Hypoglycemia
• Intervention / Treatment: Other: Controlled hypoglycemic state

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.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland
    • Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Controlled hypoglycemic state	Other: Controlled hypoglycemic state; Voice sampling is performed in different glycemic states (euglycemia and hypoglycemia).

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in hypoglycemic symptoms across the glycemic trajectory	Hypoglycemic symptoms will be assessed using the Edinburgh Hypoglycemia Scale (higher score means more symptoms).	4 hours
Change in cognitive performance across the glycemic trajectory.	Cognitive performance will be assessed using the Digit Symbol Substitution Test (higher score means better cognitive performance).	4 hours
Change in cognitive performance across the glycemic trajectory.	Cognitive performance will be assessed using the Trail Making B Test (more time needed to complete the tests means worse cognitive performance).	4 hours

Collaborators and Investigators

• Sponsor: University Hospital Inselspital, Berne
• Collaborators: Ludwig-Maximilians - University of Munich; Idiap Research Institute; CSEM Centre Suisse d'Electronique et de Microtechnique SA
• Investigators: Principal Investigator: Christoph Stettler, Prof. MD, Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Bern, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2022
• Primary Completion (Actual): January 31, 2023
• Study Completion (Actual): January 31, 2023

Study Registration Dates

• First Submitted: September 22, 2022
• First Submitted That Met QC Criteria: October 3, 2022
• First Posted (Actual): October 6, 2022

Study Record Updates

• Last Update Posted (Estimate): March 10, 2023
• Last Update Submitted That Met QC Criteria: March 8, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Hypoglycemia; Detection; Speech; Voice; Artificial intelligence (AI)
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hypoglycemia; Physiological Effects of Drugs; Hypoglycemic Agents
• Other Study ID Numbers: HypoVoice

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No