---
title: The HypoVoice Study
nct_id: NCT05569876
overall_status: COMPLETED
phase: NA
sponsor: Insel Gruppe AG, University Hospital Bern
study_type: INTERVENTIONAL
primary_condition: Diabetes Mellitus
countries: Switzerland
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05569876.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05569876"
ct_last_update_post_date: 2023-03-10
last_seen_at: "2026-05-12T06:49:50.985Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# The HypoVoice Study

**Official Title:** Vocal Biomarkers for the Detection and Prevention of Hypoglycemia (HypoVoice)

**NCT ID:** [NCT05569876](https://clinicaltrials.gov/study/NCT05569876)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 7
- **Lead Sponsor:** Insel Gruppe AG, University Hospital Bern
- **Collaborators:** Idiap Research Institute, CSEM Centre Suisse d'Electronique et de Microtechnique SA, Ludwig-Maximilians - University of Munich
- **Conditions:** Diabetes Mellitus, Hypoglycemia
- **Start Date:** 2022-11-11
- **Completion Date:** 2023-01-31
- **CT.gov Last Update:** 2023-03-10

## 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

- **Minimum age:** 18 Years
- **Maximum age:** 60 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.)
```

## Arms

- **Controlled hypoglycemic state** (OTHER)

## Interventions

- **Controlled hypoglycemic state** (OTHER) — Voice sampling is performed in different glycemic states (euglycemia and hypoglycemia).

## 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)** _(time frame: 4 hours)_
- **Voice parameters indicative of hypoglycemia** _(time frame: 4 hours)_
- **Physiological parameters indicative of hypoglycemia** _(time frame: 4 hours)_

## Locations (1)

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

## Recent Field Changes (last 30 days)

- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.department of diabetes, endocrinology, nutritional medicine and metabolism|bern||switzerland` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT05569876.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT05569876*  
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