Vocal Biomarkers for the Detection and Prevention of Hypoglycemia (HypoVoice)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetes Mellitus
- Sponsor
- Insel Gruppe AG, University Hospital Bern
- Enrollment
- 7
- Locations
- 1
- Primary Endpoint
- Diagnostic accuracy of the HypoVoice approach to detect hypoglycemia based on voice data quantified as area under the receiver operating characteristic curve (AUROC)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
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
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)
Time Frame: 4 hours
Voice data will be collected in eu- and hypoglycemia
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)(4 hours)
- Physiological parameters indicative of hypoglycemia(4 hours)
- Voice parameters indicative of hypoglycemia(4 hours)