Diabetes Mellitus, Type 2AYUDANCT07019649
Randomized Pilot Trial of AYUDA Program for Younger Latinx Adults With Type 2 Diabetes
A study testing AYUDA Program in people with Diabetes Mellitus, Type 2, run by Kaiser Permanente at 1 site in United States.
Trial summary
The study will evaluate the feasibility, acceptability, and effectiveness of AYUDA (Assisting Younger Adults with Diabetes), a 12-week culturally text message program for Latinx adults newly diagnosed with type 2 diabetes who are caregivers to a child under 18 years old within Kaiser Permanente Northern California. Read more about this study
- Who is it for?
- Ages 18 to 44 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- AYUDA Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2025to 9 Jun 2026
- 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 44 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- KPNC member, age >18 and age <45 with
- New clinical diagnosis of T2D within the prior 6 months
- Caregiver to at least one child <18 years of age at time of diabetes diagnosis
- Identifies at Latino/a/x
- Can receive text messages
- Proficient (written and spoken) in English or Spanish
Who cannot join
- Pregnant women
- Type 1 Diabetes
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Northern California
Pleasanton, California, 94588
About this study
Official title: Tailoring Initial Type 2 Diabetes Care to Meet the Needs of Younger Latinx Adults: A Randomized Pilot Study
The study will evaluate the feasibility, acceptability, and effectiveness of AYUDA (Assisting Younger Adults with Diabetes), a 12-week culturally text message program for Latinx adults newly diagnosed with type 2 diabetes who are caregivers to a child under 18 years old within Kaiser Permanente Northern California.
Read the detailed description
After designing the AYUDA program with input from the people it is meant to help, we are conducting a randomized pilot study. This study will test the program with younger Latinx adults who have recently been diagnosed with type 2 diabetes and who are also caregivers for dependent children.
AYUDA is a health system specifically designed for this group, focusing on their life stage as young adults and their cultural background. The study will evaluate how well AYUDA helps participants reach important early blood sugar control goals, which can lead to better health over time and reduce complications.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- AYUDA Program
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AYUDA ProgramBehavioural
Participants randomized to the intervention arm will be enrolled in the AYUDA program, where they will receive text messages twice a week over 12 weeks containing diabetes education and self-management resources, including links to resources available to all KPNC members.
| Study group | Role | What they receive |
|---|---|---|
| AYUDA Program | Experimental | Participants enrolled in the AYUDA program will receive text messages twice a week containing education and resources related to diabetes care and self-management, in addition to their usual diabetes care. Receives: Behavioral: AYUDA Program |
| Usual Care | No intervention | No intervention will be employed. This arm will continue to receive their usual diabetes care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences between study arms in HbA1c change 6-months following enrollment
Change in HbA1c will be assessed using HbA1c values obtained through routine care, with the most recent HbA1c preceding study enrollment and the HbA1c value closest to 6-months following enrollment used to assess HbA1c change.
Measured: 6-months following enrollment
Secondary outcomes (9)
Healthcare contact
Differences in healthcare contact with members of the T2D diabetes care team, including care manager, PCPs, educators.
Measured: 6-months following enrollment
Completion of recommended HbA1c monitoring
Completing HbA1c labs
Measured: 6-months following enrollment
T2D-related medication initiation
Initiation of T2D-related medication
Measured: 6-months following enrollment
T2D-related medication adherence
Adherence to T2D-related medication
Measured: 6-months following enrollment
Use of remote glucose monitoring to measure glucose levels
Use of a remote glucose monitoring to measure glucose levels
Measured: 6-months following enrollment
Participant-reported measures: Diabetes distress
Assessed at study enrollment and 6-months following enrollment
Measured: Study enrollment and 6-months following enrollment
Participant-reported measures: Motivation and locus of control
Assessed at study enrollment and 6-months following enrollment
Measured: Study enrollment and 6-months following enrollment
Participant-reported measures: Care Experience
Assessed at study enrollment and 6-months following enrollment
Measured: Study enrollment and 6-months following enrollment
Participant-reported measures: Children's Behaviors
Assessed at study enrollment and 6-months following enrollment
Measured: Study enrollment and 6-months following enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start25 Jul 2025
- Primary completion9 Jun 2026
- Study completion9 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- American Diabetes Association
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07019649
- Sponsor's protocol ID
- 2225114-1
- Acronym
- AYUDA
- Status last verified
- May 2025
- First submitted
- 5 Jun 2025
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailoring Initial Type 2 Diabetes Care to Meet the Needs of Younger Latinx Adults: A Randomized Pilot Study
- ClinicalTrials.gov ID
- NCT07019649
- Acronym / sponsor ID
- AYUDA / 2225114-1
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- American Diabetes Association
- Study start
- 25 Jul 2025 (actual)
- Primary completion
- 9 Jun 2026 (actual)
- Study completion
- 9 Jun 2026 (actual)
- First posted
- 13 Jun 2025 (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 study will evaluate the feasibility, acceptability, and effectiveness of AYUDA (Assisting Younger Adults with Diabetes), a 12-week culturally text message program for Latinx adults newly diagnosed with type 2 diabetes who are caregivers to a child under 18 years old within Kaiser Permanente Northern California.
Detailed description
After designing the AYUDA program with input from the people it is meant to help, we are conducting a randomized pilot study. This study will test the program with younger Latinx adults who have recently been diagnosed with type 2 diabetes and who are also caregivers for dependent children.
AYUDA is a health system specifically designed for this group, focusing on their life stage as young adults and their cultural background. The study will evaluate how well AYUDA helps participants reach important early blood sugar control goals, which can lead to better health over time and reduce complications.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AYUDA Program | Experimental | Behavioral: AYUDA ProgramParticipants enrolled in the AYUDA program will receive text messages twice a week containing education and resources related to diabetes care and self-management, in addition to their usual diabetes care. |
| Usual Care | No intervention | –No intervention will be employed. This arm will continue to receive their usual diabetes care. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- KPNC member, age >18 and age <45 with
- New clinical diagnosis of T2D within the prior 6 months
- Caregiver to at least one child <18 years of age at time of diabetes diagnosis
- Identifies at Latino/a/x
- Can receive text messages
Key exclusion criteria (2 listed)
- Pregnant women
- Type 1 Diabetes
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 |
|---|---|---|
| AYUDA ProgramParticipants randomized to the intervention arm will be enrolled in the AYUDA program, where they will receive text messages twice a week over 12 weeks containing diabetes education and self-management resources, including links to resources available to all KPNC members. | Behavioural | AYUDA Program |
Primary outcome
Differences between study arms in HbA1c change 6-months following enrollment
Time frame: 6-months following enrollment
Change in HbA1c will be assessed using HbA1c values obtained through routine care, with the most recent HbA1c preceding study enrollment and the HbA1c value closest to 6-months following enrollment used to assess HbA1c change.
9 secondary outcomes
Healthcare contact
Time frame: 6-months following enrollment
Completion of recommended HbA1c monitoring
Time frame: 6-months following enrollment
T2D-related medication initiation
Time frame: 6-months following enrollment
T2D-related medication adherence
Time frame: 6-months following enrollment
Use of remote glucose monitoring to measure glucose levels
Time frame: 6-months following enrollment
Participant-reported measures: Diabetes distress
Time frame: Study enrollment and 6-months following enrollment
Participant-reported measures: Motivation and locus of control
Time frame: Study enrollment and 6-months following enrollment
Participant-reported measures: Care Experience
Time frame: Study enrollment and 6-months following enrollment
Participant-reported measures: Children's Behaviors
Time frame: Study enrollment and 6-months following enrollment
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 31 Aug 2026.
- 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.
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 AYUDA Program in people with Diabetes Mellitus, Type 2, run by Kaiser Permanente 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 6 inclusion and 2 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 31 Aug 2026. 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?
Differences between study arms in HbA1c change 6-months following enrollment (time frame: 6-months following enrollment). 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 31 Aug 2026.