NCT05569876

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable diabetes-mellitus

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 6, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

November 11, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
Last Updated

March 10, 2023

Status Verified

March 1, 2023

Enrollment Period

3 months

First QC Date

September 22, 2022

Last Update Submit

March 8, 2023

Conditions

Diabetes MellitusHypoglycemia

Keywords

HypoglycemiaVoiceSpeechDetectionArtificial intelligence (AI)

Outcome Measures

Primary Outcomes (1)

  • 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

    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)

    4 hours

  • Voice parameters indicative of hypoglycemia

    4 hours

  • Physiological parameters indicative of hypoglycemia

    4 hours

Other Outcomes (3)

  • Change in hypoglycemic symptoms across the glycemic trajectory

    4 hours

  • Change in cognitive performance across the glycemic trajectory.

    4 hours

  • Change in cognitive performance across the glycemic trajectory.

    4 hours

Study Arms (1)

Controlled hypoglycemic state

OTHER
Other: Controlled hypoglycemic state

Interventions

Controlled hypoglycemic stateOTHER

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

Controlled hypoglycemic state

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism

Bern, Switzerland

Location

MeSH Terms

Conditions

Diabetes MellitusHypoglycemiaSpeech

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVerbal BehaviorCommunicationBehavior

Study Officials

  • Christoph Stettler, Prof. MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Participants are aware that hypoglycemia will be induced during the study but they are blinded to their blood glucose levels throughout the hypoglycemia procedure.
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2022

First Posted

October 6, 2022

Study Start

November 11, 2022

Primary Completion

January 31, 2023

Study Completion

January 31, 2023

Last Updated

March 10, 2023

Record last verified: 2023-03

Locations

CH(1)