type1diabetesPSYVOICENCT05517772
Expectations of People With Type 1 Diabetes About Voice-based Interventions to Support Diabetes Distress Management
An observational study of type1diabetes and Diabetes Distress, run by Luxembourg Institute of Health at 1 site in Luxembourg.
Trial summary
This study explores the perspectives and needs of people dealing with type 1 diabetes or their carers to co-design a voice-based digital health intervention for supporting diabetes distress management. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- type1diabetes, Diabetes Distress
- How many people
- 12 participants
- Where
- 1 siteLuxembourg
- Study dates
- 16 Jun 2022to 2 May 2023
- Phase
- Observational
- 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Diabetes clinic and diabetes patient association
Who may be able to join
- Men or women with a Type 1 diabetes diagnosis /caregivers of children diagnosed with T1D
- Able to speak and read in English, German, or French.
Who cannot join
- Unwilling or unable to participate in online interviews.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Voice of Diabetes: A Mixed-methods Study on the Needs of People With Type 1 Diabetes and Their Caregivers to Co-design a Voice-based Digital Health Solution to Support Diabetes Distress Management
This study explores the perspectives and needs of people dealing with type 1 diabetes or their carers to co-design a voice-based digital health intervention for supporting diabetes distress management.
Read the detailed description
New technologies restore people with type 1 diabetes to a certain degree of independence and control over their lives while allowing medical providers to keep an overview of their patient's general health conditions and the evolution of their treatments. Notably, solutions integrating voice-processing technology appeared to be encouraging alternatives for remote monitoring.
Diabetes distress is a common condition in people living with type 1 diabetes. Diabetes distress is associated with poor metabolic control and low quality of life. Because voice analysis involves highly complex methods for processing audio features, this kind of development might also be capable of detecting subtle changes associated with psychological factors, like diabetes distress.
Nevertheless, digital health incorporation into the everyday lives of potential users might also imply a big challenge for many of them.
For this reason, studying the needs of the end-users of technological tools before defining any aspect of their design has become a critical step in developing this kind of technology.
The main objective of Psyvoice is to identify the preferences of people living with type 1 diabetes for voice-based digital health solutions for diabetes distress detection and control.
Secondary objectives are:
- Delineating the properties that an instrument for diabetes distress management must incorporate to be considered adequate by its intended users (e.g. single voice-analysis function exclusively for diabetes distress management vs multiple functions or multiple uses).
- Determining the attributes (e.g. frequency of use) that could make a digital health solution prone to be integrated by its end-users into their everyday lives.
- Defining the characteristics likely to make a digital health solution acceptable. These are privacy and security concerns, barriers of use (difficulties with technology, disability) and facilitators of use (technical support, use of plain language).
To achieve all of these objectives, the investigators will conduct in-depth interviews.
The study will combine qualitative and quantitative methods. The investigators will invite twenty people with a T1D diagnosis or caregivers of children diagnosed with this condition to participate in semi-structured in-depth interviews and questionnaires. The questionnaires will be composed of a Socio-demographic, an e-Health Literacy (eHLQ) questionnaire, and a Diabetes Distress (PAID) scale.
- Conditions
- type1diabetes, Diabetes Distress
- Keywords
- type 1 diabetes, diabetes distress, voice technology, depression, anxiety, quality of life, digital health, vocal biomarkers
- Medical subject headings
- Diabetes Mellitus, Type 1, Depression, Anxiety Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Semi-structured interviews
Analyzing semi-structured interviews using a qualitative research methods approach will allow extracting the themes that matter for people when expressing preferences regarding digital voice technology.
Measured: At baseline
Secondary outcomes (1)
Patient reported outcomes
Diabetes distress and e-health literacy will be described with a validated self-reported scale
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start16 Jun 2022
- Primary completion2 May 2023
- Study completion2 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for type1diabetesStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luxembourg Institute of Health
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Guy A Fagherazzi, PhD, Principal investigator, Luxembourg Institute of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05517772
- Sponsor's protocol ID
- PSYVOICE
- Acronym
- PSYVOICE
- Status last verified
- Oct 2023
- First submitted
- 23 Aug 2022
- Last updated
- 25 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kiriella DA, Islam S, Oridota O, Sohler N, Dessenne C, de Beaufort C, Fagherazzi G, Aguayo GA. Unraveling the concepts of distress, burnout, and depression in type 1 diabetes: A scoping review. EClinicalMedicine. 2021 Aug 28;40:101118. doi: 10.1016/j.eclinm.2021.101118. eCollection 2021 Oct.
PubMed 34485879Mathiesen AS, Thomsen T, Jensen T, Schiotz C, Langberg H, Egerod I. The influence of diabetes distress on digital interventions for diabetes management in vulnerable people with type 2 diabetes: A qualitative study of patient perspectives. J Clin Transl Endocrinol. 2017 Jul 11;9:41-47. doi: 10.1016/j.jcte.2017.07.002. eCollection 2017 Sep.
PubMed 29067269Hart RI, Kimbell B, Rankin D, Allen JM, Boughton CK, Campbell F, de Beaufort C, Frohlich-Reiterer E, Ware J, Hofer SE, Kapellen TM, Rami-Merhar B, Thankamony A, Hovorka R, Lawton J; KidsAP Consortium. Parents' experiences of using remote monitoring technology to manage type 1 diabetes in very young children during a clinical trial: Qualitative study. Diabet Med. 2022 Jul;39(7):e14828. doi: 10.1111/dme.14828. Epub 2022 Mar 24.
PubMed 35274356Fagherazzi G, Fischer A, Ismael M, Despotovic V. Voice for Health: The Use of Vocal Biomarkers from Research to Clinical Practice. Digit Biomark. 2021 Apr 16;5(1):78-88. doi: 10.1159/000515346. eCollection 2021 Jan-Apr.
PubMed 34056518Aguirre Vergara F, Pinker I, Fischer A, Seuring T, Tichomirowa MA, de Beaufort C, Kamp SM, Fagherazzi G, Aguayo GA. Readiness of adults with type 1 diabetes and diabetes caregivers for diabetes distress monitoring using a voice-based digital health solution: insights from the PsyVoice mixed methods study. BMJ Open. 2025 Jan 2;15(1):e088424. doi: 10.1136/bmjopen-2024-088424.
PubMed 39753264Aguirre Vergara F, Fischer A, Seuring T, de Beaufort C, Fagherazzi G, Aguayo GA. Mixed-methods study protocol to identify expectations of people with type 1 diabetes and their caregivers about voice-based digital health solutions to support the management of diabetes distress: the PsyVoice study. BMJ Open. 2023 Sep 13;13(9):e068264. doi: 10.1136/bmjopen-2022-068264.
PubMed 37709324
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Voice of Diabetes: A Mixed-methods Study on the Needs of People With Type 1 Diabetes and Their Caregivers to Co-design a Voice-based Digital Health Solution to Support Diabetes Distress Management
- ClinicalTrials.gov ID
- NCT05517772
- Acronym / sponsor ID
- PSYVOICE / PSYVOICE
- Conditions
- type1diabetes, Diabetes Distress
- Keywords
- type 1 diabetes, diabetes distress, voice technology, depression, anxiety, quality of life, digital health, vocal biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Luxembourg Institute of HealthOther government
- Study start
- 16 Jun 2022 (actual)
- Primary completion
- 2 May 2023 (actual)
- Study completion
- 2 May 2023 (actual)
- First posted
- 26 Aug 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.
This study explores the perspectives and needs of people dealing with type 1 diabetes or their carers to co-design a voice-based digital health intervention for supporting diabetes distress management.
Detailed description
New technologies restore people with type 1 diabetes to a certain degree of independence and control over their lives while allowing medical providers to keep an overview of their patient's general health conditions and the evolution of their treatments. Notably, solutions integrating voice-processing technology appeared to be encouraging alternatives for remote monitoring.
Diabetes distress is a common condition in people living with type 1 diabetes. Diabetes distress is associated with poor metabolic control and low quality of life. Because voice analysis involves highly complex methods for processing audio features, this kind of development might also be capable of detecting subtle changes associated with psychological factors, like diabetes distress.
Nevertheless, digital health incorporation into the everyday lives of potential users might also imply a big challenge for many of them.
For this reason, studying the needs of the end-users of technological tools before defining any aspect of their design has become a critical step in developing this kind of technology.
The main objective of Psyvoice is to identify the preferences of people living with type 1 diabetes for voice-based digital health solutions for diabetes distress detection and control.
Secondary objectives are:
- Delineating the properties that an instrument for diabetes distress management must incorporate to be considered adequate by its intended users (e.g. single voice-analysis function exclusively for diabetes distress management vs multiple functions or multiple uses).
- Determining the attributes (e.g. frequency of use) that could make a digital health solution prone to be integrated by its end-users into their everyday lives.
- Defining the characteristics likely to make a digital health solution acceptable. These are privacy and security concerns, barriers of use (difficulties with technology, disability) and facilitators of use (technical support, use of plain language).
To achieve all of these objectives, the investigators will conduct in-depth interviews.
The study will combine qualitative and quantitative methods. The investigators will invite twenty people with a T1D diagnosis or caregivers of children diagnosed with this condition to participate in semi-structured in-depth interviews and questionnaires. The questionnaires will be composed of a Socio-demographic, an e-Health Literacy (eHLQ) questionnaire, and a Diabetes Distress (PAID) scale.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Diabetes clinic and diabetes patient association
Key inclusion criteria (2 listed)
- Men or women with a Type 1 diabetes diagnosis /caregivers of children diagnosed with T1D
- Able to speak and read in English, German, or French.
Key exclusion criteria (1 listed)
- Unwilling or unable to participate in online interviews.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Semi-structured interviews
Time frame: At baseline
Analyzing semi-structured interviews using a qualitative research methods approach will allow extracting the themes that matter for people when expressing preferences regarding digital voice technology.
1 secondary outcome
Patient reported outcomes
Time frame: At baseline
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 25 Oct 2023.
- Background: PubMed 34485879Kiriella DA, Islam S, Oridota O, Sohler N, Dessenne C, de Beaufort C, Fagherazzi G, Aguayo GA. Unraveling the concepts of distress, burnout, and depression in type 1 diabetes: A scoping review. EClinicalMedicine. 2021 Aug 28;40:101118. doi: 10.1016/j.eclinm.2021.101118. eCollection 2021 Oct.
- Background: PubMed 29067269Mathiesen AS, Thomsen T, Jensen T, Schiotz C, Langberg H, Egerod I. The influence of diabetes distress on digital interventions for diabetes management in vulnerable people with type 2 diabetes: A qualitative study of patient perspectives. J Clin Transl Endocrinol. 2017 Jul 11;9:41-47. doi: 10.1016/j.jcte.2017.07.002. eCollection 2017 Sep.
- Background: PubMed 35274356Hart RI, Kimbell B, Rankin D, Allen JM, Boughton CK, Campbell F, de Beaufort C, Frohlich-Reiterer E, Ware J, Hofer SE, Kapellen TM, Rami-Merhar B, Thankamony A, Hovorka R, Lawton J; KidsAP Consortium. Parents' experiences of using remote monitoring technology to manage type 1 diabetes in very young children during a clinical trial: Qualitative study. Diabet Med. 2022 Jul;39(7):e14828. doi: 10.1111/dme.14828. Epub 2022 Mar 24.
- Background: PubMed 34056518Fagherazzi G, Fischer A, Ismael M, Despotovic V. Voice for Health: The Use of Vocal Biomarkers from Research to Clinical Practice. Digit Biomark. 2021 Apr 16;5(1):78-88. doi: 10.1159/000515346. eCollection 2021 Jan-Apr.
- Derived from this study: PubMed 39753264Aguirre Vergara F, Pinker I, Fischer A, Seuring T, Tichomirowa MA, de Beaufort C, Kamp SM, Fagherazzi G, Aguayo GA. Readiness of adults with type 1 diabetes and diabetes caregivers for diabetes distress monitoring using a voice-based digital health solution: insights from the PsyVoice mixed methods study. BMJ Open. 2025 Jan 2;15(1):e088424. doi: 10.1136/bmjopen-2024-088424.
- Derived from this study: PubMed 37709324Aguirre Vergara F, Fischer A, Seuring T, de Beaufort C, Fagherazzi G, Aguayo GA. Mixed-methods study protocol to identify expectations of people with type 1 diabetes and their caregivers about voice-based digital health solutions to support the management of diabetes distress: the PsyVoice study. BMJ Open. 2023 Sep 13;13(9):e068264. doi: 10.1136/bmjopen-2022-068264.
- Individual participant dataSharing planned: No
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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.
Guy A Fagherazzi, PhD principal investigator
Luxembourg Institute of Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of type1diabetes and Diabetes Distress, run by Luxembourg Institute of Health at 1 site in Luxembourg.
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 2 inclusion and 1 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 25 Oct 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 Luxembourg. 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?
Semi-structured interviews (time frame: At baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05517772, which also lists 6 linked publications.
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 25 Oct 2023.