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The HypoVoice Study (HypoVoice)

Primary Purpose

Diabetes Mellitus, Hypoglycemia

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Controlled hypoglycemic state
Sponsored by
Insel Gruppe AG, University Hospital Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Diabetes Mellitus focused on measuring Hypoglycemia, Voice, Speech, Detection, Artificial intelligence (AI)

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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.)

Sites / Locations

  • Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Controlled hypoglycemic state

Arm Description

Outcomes

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)
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)
Voice and physiological data will be collected in eu- and hypoglycemia
Voice parameters indicative of hypoglycemia
Explainable AI methods will be used to identify voice parameters indicative of hypoglycemia
Physiological parameters indicative of hypoglycemia
Explainable AI methods will be used to identify physiological parameters indicative of hypoglycemia

Full Information

First Posted
September 22, 2022
Last Updated
March 8, 2023
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
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1. Study Identification

Unique Protocol Identification Number
NCT05569876
Brief Title
The HypoVoice Study
Acronym
HypoVoice
Official Title
Vocal Biomarkers for the Detection and Prevention of Hypoglycemia (HypoVoice)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
November 11, 2022 (Actual)
Primary Completion Date
January 31, 2023 (Actual)
Study Completion Date
January 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the 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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Hypoglycemia
Keywords
Hypoglycemia, Voice, Speech, Detection, Artificial intelligence (AI)

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study 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.
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Controlled hypoglycemic state
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Controlled hypoglycemic state
Intervention Description
Voice sampling is performed in different glycemic states (euglycemia and hypoglycemia).
Primary Outcome Measure Information:
Title
Diagnostic accuracy of the HypoVoice approach to detect hypoglycemia based on voice data quantified as area under the receiver operating characteristic curve (AUROC)
Description
Voice data will be collected in eu- and hypoglycemia
Time Frame
4 hours
Secondary Outcome Measure Information:
Title
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)
Description
Voice and physiological data will be collected in eu- and hypoglycemia
Time Frame
4 hours
Title
Voice parameters indicative of hypoglycemia
Description
Explainable AI methods will be used to identify voice parameters indicative of hypoglycemia
Time Frame
4 hours
Title
Physiological parameters indicative of hypoglycemia
Description
Explainable AI methods will be used to identify physiological parameters indicative of hypoglycemia
Time Frame
4 hours
Other Pre-specified Outcome Measures:
Title
Change in hypoglycemic symptoms across the glycemic trajectory
Description
Hypoglycemic symptoms will be assessed using the Edinburgh Hypoglycemia Scale (higher score means more symptoms).
Time Frame
4 hours
Title
Change in cognitive performance across the glycemic trajectory.
Description
Cognitive performance will be assessed using the Digit Symbol Substitution Test (higher score means better cognitive performance).
Time Frame
4 hours
Title
Change in cognitive performance across the glycemic trajectory.
Description
Cognitive performance will be assessed using the Trail Making B Test (more time needed to complete the tests means worse cognitive performance).
Time Frame
4 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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 Active drug or alcohol abuse Medication known to interfere with voice or to induce listlessness (e.g. opioids, benzodiazepines, etc.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christoph Stettler, Prof. MD
Organizational Affiliation
Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Bern, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism
City
Bern
Country
Switzerland

12. IPD Sharing Statement

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The HypoVoice Study

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