Diabetes MellitusHypoVoiceNCT05569876
The HypoVoice Study
A study of Diabetes Mellitus and Hypoglycemia, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
The HypoVoice study aims at identifying potential vocal biomarkers associated with hypoglycemia to pave the way towards a voice-based hypoglycemia detection approach. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Diabetes Mellitus, Hypoglycemia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteSwitzerland
- Study dates
- 11 Nov 2022to 31 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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)
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- 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.)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism
Bern
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetes Mellitus, Hypoglycemia
- Being tested
- Controlled hypoglycemic state
- Keywords
- Hypoglycemia, Voice, Speech, Detection, Artificial intelligence (AI)
- Medical subject headings
- Diabetes Mellitus, Hypoglycemia, Speech
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Controlled hypoglycemic stateOther
Voice sampling is performed in different glycemic states (euglycemia and hypoglycemia).
| Study group | Role | What they receive |
|---|---|---|
| Controlled hypoglycemic state | Other | Not described Receives: Other: Controlled hypoglycemic state |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 hours
Secondary outcomes (3)
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
Measured: 4 hours
Voice parameters indicative of hypoglycemia
Explainable AI methods will be used to identify voice parameters indicative of hypoglycemia
Measured: 4 hours
Physiological parameters indicative of hypoglycemia
Explainable AI methods will be used to identify physiological parameters indicative of hypoglycemia
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study start11 Nov 2022
- Primary completion31 Jan 2023
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Idiap Research Institute, CSEM Centre Suisse d'Electronique et de Microtechnique SA, Ludwig-Maximilians - University of Munich
- Responsible party
- Sponsor
- Investigators
- Christoph Stettler, Prof. MD, Principal investigator, Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Bern, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05569876
- Sponsor's protocol ID
- HypoVoice
- Acronym
- HypoVoice
- Status last verified
- Mar 2023
- First submitted
- 22 Sep 2022
- Last updated
- 10 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vocal Biomarkers for the Detection and Prevention of Hypoglycemia (HypoVoice)
- ClinicalTrials.gov ID
- NCT05569876
- Acronym / sponsor ID
- HypoVoice / HypoVoice
- Conditions
- Diabetes Mellitus, Hypoglycemia
- Keywords
- Hypoglycemia, Voice, Speech, Detection, Artificial intelligence (AI)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Idiap Research Institute, CSEM Centre Suisse d'Electronique et de Microtechnique SA, Ludwig-Maximilians - University of Munich
- Study start
- 11 Nov 2022 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 6 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Controlled hypoglycemic state | Other | Other: Controlled hypoglycemic state |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Controlled hypoglycemic stateVoice sampling is performed in different glycemic states (euglycemia and hypoglycemia). | Other | Controlled hypoglycemic state |
Primary outcome
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
3 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoph Stettler, Prof. MD principal investigator
Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Bern, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Diabetes Mellitus and Hypoglycemia, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2023; AzTrials last refreshed its copy on 29 Oct 2026.