Type1diabetesT1DESNCT05735340
Type 1 Diabetes Education and Support Study
A study testing Diabetes Education and T1DES in people with Type1diabetes, run by Kaiser Permanente at 1 site in United States.
Trial summary
Diabetes distress has been identified as one of the largest contributors to the racial disparity in glycemic control that disproportionately burdens Black patients ages 18-30 years with type 1 diabetes (T1D). Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Type1diabetes
- What is being tested?
- Diabetes Education and T1DES
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2023to 6 Feb 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 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Kaiser Permanente Georgia Member
- Aged 18 - 30 years
- Confirmed diagnosis of Type 1 diabetes
- Hemoglobin A1c > 7.5 at time of enrollment
- a cell phone able to send/receive text messages
- Self-reported race of Black or African American
- Ability to read in English and provide informed consent
Who cannot join
- Developmental delay or other cognitive impairment that would render the participant unable to provide informed consent
- Subjects with visual impairment or have severe hearing or other physical disabilities that would be a barrier for participating in-group or web sessions
- Diabetes complications that would preclude participation in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Feasibility of Type 1 Diabetes Education and Support Intervention to Improve Diabetes Distress Among Black Young Adults
Diabetes distress has been identified as one of the largest contributors to the racial disparity in glycemic control that disproportionately burdens Black patients ages 18-30 years with type 1 diabetes (T1D). In order to combat this issue, this study assesses the feasibility of the culturally tailored intervention T1DES and evaluates the effect of the T1DES intervention on diabetes outcomes in a pilot randomized clinical trial among Black young adults with T1D.
Read the detailed description
This research focuses on the unique needs of Black young adults aged 18-30 years to address a critical gap in the research and clinical care. The goal is to test the feasibility and preliminary efficacy of a culturally adapted and tailored intervention to enhance diabetes management strategies among Black young adults with T1D, addressing the pervasive racial disparity in health outcomes for this population.
The specific aims for this study are to:
Aim 1: Assess feasibility of the culturally tailored intervention T1DES by measuring intervention acceptability, demand (retention, completed > 80% of sessions), practicality, and implementation fidelity through participant surveys and key informant interviews with participants and the health care delivery team.
Aim 2: Evaluate the effect of the T1DES intervention on diabetes outcomes in a pilot randomized clinical trial among N=40 Black young adults age 18-30 years with T1D and elevated HbA1c (>7.5%) by comparing changes in HbA1c, diabetes distress, and self-management from baseline to 6-months post-baseline among participants randomized to T1DES compared to the diabetes education-only control condition.
The goal of this study is to provide diabetes education and emotion regulation support tailored for Black young adults' experiences that will result in sustained glycemic control and can be incorporated into adult endocrinology practices.
- Conditions
- Type1diabetes
- Being tested
- Diabetes Education, T1DES
- Keywords
- diabetes, type 1
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes EducationBehavioural
Participants in this arm will receive traditional diabetes education over 5 sessions in the first 3 months of participation and be followed for 6 months.
T1DESBehavioural
Participants in this arm will receive the T1DES behavioral interventions over 5 sessions in the first 3 months of participation and be followed for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Diabetes Education | Active comparator | Participants in this arm will receive traditional diabetes education following a baseline assessment. During months 1-3, participants will attend 5 sessions. Follow-up will be conducted at 3-months and 6-months. Receives: Behavioral: Diabetes Education |
| T1DES | Experimental | Participants in this arm will receive a emotion regulation intervention called T1DES following a baseline assessment. During months 1-3, participants will attend 5 sessions. Follow-up will be conducted at 3-months and 6-months. Receives: Behavioral: T1DES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetes Distress
Problem Areas in Diabetes - Emerging Adults 25 Item Measure and Scoring. Higher scores indicate more diabetes distress, with a range from 0 to 100.
Measured: 3 months
Diabetes Distress
Problem Areas in Diabetes - Emerging Adults 25 Item Measure and Scoring. Higher scores indicate more diabetes distress, with a range from 0 to 100.
Measured: 6 months
Diabetes Distress
Type 1 Diabetes Distress Scale. Higher scores indicate more diabetes distress, with a range from 1 to 6.
Measured: 3 months
Diabetes Distress
Type 1 Diabetes Distress Scale. Higher scores indicate more diabetes distress, with a range from 1 to 6.
Measured: 6 months
A1C
Point of Care A1C
Measured: 3 months
A1C
Point of Care A1C
Measured: 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start15 Apr 2023
- Primary completion6 Feb 2026
- Study completion6 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Emory University
- Responsible party
- Sponsor
- Investigators
- Teaniese L Davis, PhD, MPH, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05735340
- Sponsor's protocol ID
- 1910751
- Other IDs
- 1R01DK128236-01A1
- Acronym
- T1DES
- Status last verified
- May 2026
- First submitted
- 30 Jan 2023
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Davis TL, McCracken C, Fisher L, Graetz I, Barzilay J, Vellanki P, Haw JS, Gonzalez Paz L, Wolf R, Crawford M, Wright M, Bock F, Sekar S. Feasibility and signals of efficacy of the Type 1 Diabetes Education and Support (T1DES) intervention to improve diabetes distress and glycemic levels among Black young adults with type 1 diabetes compared to standard diabetes education: study protocol for a randomized pilot trial. Pilot Feasibility Stud. 2026 Apr 1;12(1):65. doi: 10.1186/s40814-026-01776-z.
PubMed 41918050
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Feasibility of Type 1 Diabetes Education and Support Intervention to Improve Diabetes Distress Among Black Young Adults
- ClinicalTrials.gov ID
- NCT05735340
- Acronym / sponsor ID
- T1DES / 1910751
- Conditions
- Type1diabetes
- Keywords
- diabetes, type 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Emory University
- Study start
- 15 Apr 2023 (actual)
- Primary completion
- 6 Feb 2026 (actual)
- Study completion
- 6 Feb 2026 (actual)
- First posted
- 21 Feb 2023 (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.
Diabetes distress has been identified as one of the largest contributors to the racial disparity in glycemic control that disproportionately burdens Black patients ages 18-30 years with type 1 diabetes (T1D). In order to combat this issue, this study assesses the feasibility of the culturally tailored intervention T1DES and evaluates the effect of the T1DES intervention on diabetes outcomes in a pilot randomized clinical trial among Black young adults with T1D.
Detailed description
This research focuses on the unique needs of Black young adults aged 18-30 years to address a critical gap in the research and clinical care. The goal is to test the feasibility and preliminary efficacy of a culturally adapted and tailored intervention to enhance diabetes management strategies among Black young adults with T1D, addressing the pervasive racial disparity in health outcomes for this population.
The specific aims for this study are to:
Aim 1: Assess feasibility of the culturally tailored intervention T1DES by measuring intervention acceptability, demand (retention, completed > 80% of sessions), practicality, and implementation fidelity through participant surveys and key informant interviews with participants and the health care delivery team.
Aim 2: Evaluate the effect of the T1DES intervention on diabetes outcomes in a pilot randomized clinical trial among N=40 Black young adults age 18-30 years with T1D and elevated HbA1c (>7.5%) by comparing changes in HbA1c, diabetes distress, and self-management from baseline to 6-months post-baseline among participants randomized to T1DES compared to the diabetes education-only control condition.
The goal of this study is to provide diabetes education and emotion regulation support tailored for Black young adults' experiences that will result in sustained glycemic control and can be incorporated into adult endocrinology practices.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetes Education | Active comparator | Behavioral: Diabetes EducationParticipants in this arm will receive traditional diabetes education following a baseline assessment. During months 1-3, participants will attend 5 sessions. Follow-up will be conducted at 3-months and 6-months. |
| T1DES | Experimental | Behavioral: T1DESParticipants in this arm will receive a emotion regulation intervention called T1DES following a baseline assessment. During months 1-3, participants will attend 5 sessions. Follow-up will be conducted at 3-months and 6-months. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Kaiser Permanente Georgia Member
- Aged 18 - 30 years
- Confirmed diagnosis of Type 1 diabetes
- Hemoglobin A1c > 7.5 at time of enrollment
- a cell phone able to send/receive text messages
Key exclusion criteria (3 listed)
- Developmental delay or other cognitive impairment that would render the participant unable to provide informed consent
- Subjects with visual impairment or have severe hearing or other physical disabilities that would be a barrier for participating in-group or web sessions
- Diabetes complications that would preclude participation in the study
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 |
|---|---|---|
| Diabetes EducationParticipants in this arm will receive traditional diabetes education over 5 sessions in the first 3 months of participation and be followed for 6 months. | Behavioural | Diabetes Education |
| T1DESParticipants in this arm will receive the T1DES behavioral interventions over 5 sessions in the first 3 months of participation and be followed for 6 months. | Behavioural | T1DES |
Primary outcome
Diabetes Distress
Time frame: 3 months
Problem Areas in Diabetes - Emerging Adults 25 Item Measure and Scoring. Higher scores indicate more diabetes distress, with a range from 0 to 100.
Diabetes Distress
Time frame: 6 months
Problem Areas in Diabetes - Emerging Adults 25 Item Measure and Scoring. Higher scores indicate more diabetes distress, with a range from 0 to 100.
Diabetes Distress
Time frame: 3 months
Type 1 Diabetes Distress Scale. Higher scores indicate more diabetes distress, with a range from 1 to 6.
Diabetes Distress
Time frame: 6 months
Type 1 Diabetes Distress Scale. Higher scores indicate more diabetes distress, with a range from 1 to 6.
A1C
Time frame: 3 months
Point of Care A1C
A1C
Time frame: 6months
Point of Care A1C
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 6 May 2026.
- Background: PubMed 41918050Davis TL, McCracken C, Fisher L, Graetz I, Barzilay J, Vellanki P, Haw JS, Gonzalez Paz L, Wolf R, Crawford M, Wright M, Bock F, Sekar S. Feasibility and signals of efficacy of the Type 1 Diabetes Education and Support (T1DES) intervention to improve diabetes distress and glycemic levels among Black young adults with type 1 diabetes compared to standard diabetes education: study protocol for a randomized pilot trial. Pilot Feasibility Stud. 2026 Apr 1;12(1):65. doi: 10.1186/s40814-026-01776-z.
- 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.
Teaniese L Davis, PhD, MPH principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diabetes Education and T1DES in people with Type1diabetes, 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 7 inclusion and 3 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 6 May 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?
Diabetes Distress (time frame: 3 months). The study lists 6 primary outcomes in all. 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 NCT05735340, which also lists 1 linked publication.
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 6 May 2026.