DiabetesNCT06577506
Diabetes Education and Care for Deaf Populations
A study testing Deaf Diabetes Can Together in people with Diabetes, run by University of Utah at 1 site in United States.
Trial summary
This study will assess the feasibility and preliminary efficacy of a 10-week intervention called "Deaf Diabetes Can Together". Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- Deaf Diabetes Can Together
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2023to 1 Sep 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Identify as Deaf/Hard of Hearing
- living with diabetes (any type)
- speak and understand English or American Sign Language
- have access to internet
- willing to participate in the intervention
Who cannot join
- participating in another diabetes study
- have significant cognitive impairment
- are pregnant or planning to become pregnant in the next year
- have life expectancy of <6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Access to Diabetes Education and Care for Deaf Populations
This study will assess the feasibility and preliminary efficacy of a 10-week intervention called "Deaf Diabetes Can Together".
- Conditions
- Diabetes
- Being tested
- Deaf Diabetes Can Together
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deaf Diabetes Can TogetherBehavioural
10-week diabetes self-management telehealth intervention for deaf adults with diabetes.
| Study group | Role | What they receive |
|---|---|---|
| Deaf Diabetes Can Together | Experimental | Not described Receives: Behavioral: Deaf Diabetes Can Together |
What is being measured
The primary outcome is the main question the study is designed to answer.
A1C Level
Clinical outcome
Measured: 6 months: (Test at 0 weeks, 12 weeks, and 24 weeks)
Secondary outcomes (2)
Diabetes Distress Level Using the Screening Scale Questionnaire
Psychosocial outcome, scoring averaged from 1-6 with higher score means worse outcome.
Measured: 6 months: (Test at 0 weeks, 12 weeks, and 24 weeks)
Diabetes Self-Care Level using the Self-Care Inventory Revised Questionnaire
Self-management outcome, scoring averaged from 0-100 point scale with higher score means better outcome.
Measured: 6 months: (Test at 0 weeks, 12 weeks, and 24 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start17 Aug 2023
- Primary completion22 Jul 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michelle Litchman, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06577506
- Sponsor's protocol ID
- 00151575
- Status last verified
- Apr 2025
- First submitted
- 7 Nov 2023
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Access to Diabetes Education and Care for Deaf Populations
- ClinicalTrials.gov ID
- NCT06577506
- Acronym / sponsor ID
- 00151575
- Conditions
- Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 17 Aug 2023 (actual)
- Primary completion
- 22 Jul 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 29 Aug 2024 (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 will assess the feasibility and preliminary efficacy of a 10-week intervention called "Deaf Diabetes Can Together".
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Deaf Diabetes Can Together | Experimental | Behavioral: Deaf Diabetes Can Together |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Identify as Deaf/Hard of Hearing
- living with diabetes (any type)
- speak and understand English or American Sign Language
- have access to internet
- willing to participate in the intervention
Key exclusion criteria (4 listed)
- participating in another diabetes study
- have significant cognitive impairment
- are pregnant or planning to become pregnant in the next year
- have life expectancy of <6 months
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 |
|---|---|---|
| Deaf Diabetes Can Together10-week diabetes self-management telehealth intervention for deaf adults with diabetes. | Behavioural | Deaf Diabetes Can Together |
Primary outcome
A1C Level
Time frame: 6 months: (Test at 0 weeks, 12 weeks, and 24 weeks)
Clinical outcome
2 secondary outcomes
Diabetes Distress Level Using the Screening Scale Questionnaire
Time frame: 6 months: (Test at 0 weeks, 12 weeks, and 24 weeks)
Diabetes Self-Care Level using the Self-Care Inventory Revised Questionnaire
Time frame: 6 months: (Test at 0 weeks, 12 weeks, and 24 weeks)
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 Apr 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deaf Diabetes Can Together in people with Diabetes, run by University of Utah at 1 site in United States.
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 5 inclusion and 4 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 Apr 2025. 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 United States. 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?
A1C Level (time frame: 6 months: (Test at 0 weeks, 12 weeks, and 24 weeks)). 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 Apr 2025.