The HypoVoice Study

Not Applicable

Completed

• Conditions: Hypoglycemia; Diabetes Mellitus
• Interventions: Other: Controlled hypoglycemic state

• Registration Number: NCT05569876
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

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.

Study Timeline

• Study First Submitted: 2022-09-22
• Study First Submitted QC: 2022-10-03
• Study First Posted: 2022-10-06
• Study Start: 2022-11-11
• Primary Completion: 2023-01-31
• Study Completion: 2023-01-31
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-08
• Last Update Posted: 2023-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Controlled hypoglycemic state	Controlled hypoglycemic state	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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)	4 hours	Voice and physiological data will be collected in eu- and hypoglycemia
Physiological parameters indicative of hypoglycemia	4 hours	Explainable AI methods will be used to identify physiological parameters indicative of hypoglycemia
Voice parameters indicative of hypoglycemia	4 hours	Explainable AI methods will be used to identify voice parameters indicative of hypoglycemia

Trial Locations

Locations (1)

Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism; 🇨🇭 Bern, Switzerland