The HypoVoice Study

Sponsor

University Hospital Inselspital, Berne (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05569876

Collaborator

Idiap Research Institute (Other), CSEM Centre Suisse d'Electronique et de Microtechnique SA (Other), Ludwig-Maximilians - University of Munich (Other)

Enrollment

Arm

2.5

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus Hypoglycemia	Other: Controlled hypoglycemic state	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

6 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Masking Description:

Participants are aware that hypoglycemia will be induced during the study but they are blinded to their blood glucose levels throughout the hypoglycemia procedure.

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Oct 15, 2022

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

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

Arm

Intervention/Treatment

Other: Controlled hypoglycemic state

Other: Controlled hypoglycemic state

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

Outcome Measures

Primary Outcome Measures

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

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
Voice parameters indicative of hypoglycemia [4 hours]
Explainable AI methods will be used to identify voice parameters indicative of hypoglycemia
Physiological parameters indicative of hypoglycemia [4 hours]
Explainable AI methods will be used to identify physiological parameters indicative of hypoglycemia

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.)