Type 1 Diabetes (T1D)TREAT-EDNCT06626347
Telemedicine for Reach, Education, Access, and Treatment for Diabetes Self-Management Education and Support
A study testing TREAT-ED Virtual Group Diabetes Self-Management Education and Support in people with Type 1 Diabetes (T1D), run by University of Pittsburgh at 1 site in United States.
Trial summary
Emerging adults with type 1 diabetes are a vulnerable population. While diabetes self-management and education is known to offer opportunities to develop self-management skills required to achieve and maintain short- and long-term diabetes outcomes, emerging adults are reported to have poor clinic attendance and in… Read more about this study
- Who is it for?
- Ages 18 to 26 years
- Conditions the study is for
- Type 1 Diabetes (T1D)
- What is being tested?
- TREAT-ED Virtual Group Diabetes Self-Management Education and Support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2024to 31 May 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 26 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed with type 1 diabetes (ICD10 E10.xx, O24.0x)
- 18 to 26 years of age at time of study enrollment
- Able to communicate via videoconferencing platform
- Intending to maintain status as a patient at participating clinical sites throughout the study duration
- Able to provide informed consent
Who cannot join
- Do not have a diagnosis of type 1 diabetes (ICD10 E10.xx, O24.0x)
- Less than 18 or older than 26 years old at time of enrollment
- Do not intend to maintain their care at participating clinical sites throughout the duration of the study
- Are unable to communicate via telemedicine
- Has other concerns that may interfere significantly with their ability to participate in the intervention (ongoing health issues, personal events, etc.)
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Childrens Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
About this study
Official title: Application of the Telemedicine for Reach, Education, Access, and Treatment Delivery Model to Engage Emerging Adults in Diabetes Self-Management Education and Support
Emerging adults with type 1 diabetes are a vulnerable population. While diabetes self-management and education is known to offer opportunities to develop self-management skills required to achieve and maintain short- and long-term diabetes outcomes, emerging adults are reported to have poor clinic attendance and in turn low participation in diabetes self-management education and support services. This pilot study aims to test a novel approach to diabetes self-management education and support that incorporates technological and applied learning-driven methods delivered through group telemedicine visits to improve emerging adults engagement in diabetes self-management education and support with the ultimate goal of improving diabetes outcomes.
Read the detailed description
Diabetes self-management education and support is considered a cornerstone of care and essential in helping people navigate self-management decisions and activities. Despite evidence that diabetes self-management education and support is a critical component of diabetes care, participation remains low. Emerging adulthood has been described as the distinct period between 18 and 25 years when adolescents work to achieve autonomy and explore life possibilities in moving toward adulthood. Suboptimal self-management has been identified as a major problem in emerging adults with type 1 diabetes, a particularly vulnerable group with an increased risk for poor diabetes-related outcomes. In its current form diabetes self-management education and support has been cited for not meeting the needs of emerging adults, when emerging adults have expressed interest in diabetes self-management education and support delivered with peer-supported, technological and applied learning-driven methods. To address these challenges, we are applying information gained from the literature and key stakeholder groups to our established Telemedicine for Reach, Education, Access and Treatment (TREAT) delivery model with a specific focus on diabetes self-management education and support. TREAT-ED (for self-management EDucation) will be designed to specifically engage emerging adults by integrating diabetes self-management education and support objectives to support informed decision making, self-care, and preparation for transfer to adult care, to improve outcomes. Diabetes care and education specialists will lead TREAT-ED with a cohort of emerging adults and will 1) help to organize and facilitate group sessions delivered through telehealth and 2) use continuous blood glucose monitoring reports as personalized examples to drive established diabetes self-management education and support content. With user-centered design techniques we developed and built and will now evaluate implementation determinants and test the TREAT-ED model. Feasibility assessment of the impact of the model on emerging adult patient participation in diabetes self-management education and support along with clinical, psychosocial and behavioral outcomes will be examined. We hypothesize that models that rely on current day strategies to engage emerging adults at high risk for diabetes-related problems with effective self-management skills will improve diabetes self-management education and support engagement and outcomes. If proven to be effective, this model is one that could be adapted for emerging adults who have transferred to adult diabetes care and other patient populations throughout the United States.
- Conditions
- Type 1 Diabetes (T1D)
- Being tested
- TREAT-ED Virtual Group Diabetes Self-Management Education and Support
- Keywords
- Type 1 Diabetes, Emerging Adults, Telemedicine, Health Care Delivery, Diabetes Self-Management Education and Support, Visit Attendance
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TREAT-ED Virtual Group Diabetes Self-Management Education and SupportOther
TREAT-ED is an innovative group telehealth delivery model designed to engage emerging adults in DSMES services. TREAT-ED sessions are facilitated by a Diabetes Care and Education Specialist and include content centered around the ADCES7 Self-Care Behaviors and applied learning strategies, e.g., case scenarios integrating glucose monitoring, and group discussions to drive knowledge transfer and skill development for diabetes self-care behaviors within the context of issues that are salient to the target population.
| Study group | Role | What they receive |
|---|---|---|
| TREAT-ED | Experimental | * Emerging adult patients with type 1 diabetes assigned to groups of eight participants on average.
* Four diabetes self-management education and support group sessions delivered virtually each session lasting 30-45 minutes.
* Group sessions scheduled at intervals decided up on by participants. Receives: Other: TREAT-ED Virtual Group Diabetes Self-Management Education and Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of diabetes self-management education and support sessions attended
Possible range is 0 to 4 sessions.
Measured: From baseline to 6 months
Secondary outcomes (8)
Change from baseline in empowerment at 6 months
Empowerment will be assessed with the 8-item Diabetes Empowerment Scale-Short Form. Individual items are scored from 1 to 5; total scores are the average of all individual items. Higher scores indicate a greater sense of empowerment.
Measured: Baseline vs. 6 months
Change from baseline in readiness for transition at 6 months
Transition readiness and self-management skill level will be assessed with the Transition Readiness Assessment Questionnaire. Individual items are scored from 1 to 5; total scores are the average of all individual items. The higher the score, the greater the readiness for transition to adult care.
Measured: Baseline vs. 6 months
Change from baseline in self-efficacy at 6 months
Self-efficacy will be assessed using the 10-item Self-Efficacy for Diabetes Self-Management scale. Individuals items are scored from 1 to 10; total scores are the average of all individual items. Higher scores indicate greater self-efficacy.
Measured: Baseline vs. 6 months
Change from baseline in diabetes distress at 6 months
Diabetes distress will be assessed with the Type 1 Diabetes Distress Assessment System: CORE SCALE. The CORE SCALE includes 8 items. Individual items are scored from 1 to 5; total scores are the average of all individual items. The higher the score, the greater the level of distress.
Measured: Baseline vs. 6 months
Change in percentage of patients with glycemic control from baseline to 6 months.
Glycemic control defined as clinically measured hemoglobin A1c value of 7% or less. Values will be identified through medical record review.
Measured: Baseline vs. 6 months
Percentage of time in target glycemic range (70-180 mg/dL)
Time in target glycemic range (70-180 mg/dL) is evaluated in 14 day periods using data recorded on continuous glucose monitoring systems and documented in the electronic health record system. This data will only be available for participants who use a continuous glucose monitor and provide data for documentation.
Measured: From baseline to 6 months
Number of acute care visits
Number of emergency room visits and hospital admissions related to type 1 diabetes; documented in the medical record system.
Measured: From baseline to 6 months
Number of diabetes clinic visits attended
Diabetes clinic visits with an endocrinologist are recommended to occur every three months or more frequently as needed at the participating institution and are documented in the medical record.
Measured: From baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start8 Nov 2024
- Primary completion31 Jan 2026
- Study completion31 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes (T1D)Studies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ingrid Libman, University of Pittsburgh
- Investigators
- Ingrid Libman, MD, PhD, Principal investigator, University of PittsburghLinda Siminerio, RN, PhD, CDCES, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06626347
- Sponsor's protocol ID
- STUDY24070160
- Other IDs
- R34DK136020
- Acronym
- TREAT-ED
- Status last verified
- Jun 2026
- First submitted
- 1 Oct 2024
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified IPD that underlies results reported in publication.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of the Telemedicine for Reach, Education, Access, and Treatment Delivery Model to Engage Emerging Adults in Diabetes Self-Management Education and Support
- ClinicalTrials.gov ID
- NCT06626347
- Acronym / sponsor ID
- TREAT-ED / STUDY24070160
- Conditions
- Type 1 Diabetes (T1D)
- Keywords
- Type 1 Diabetes, Emerging Adults, Telemedicine, Health Care Delivery, Diabetes Self-Management Education and Support, Visit Attendance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 8 Nov 2024 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 31 May 2026 (actual)
- First posted
- 3 Oct 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.
Emerging adults with type 1 diabetes are a vulnerable population. While diabetes self-management and education is known to offer opportunities to develop self-management skills required to achieve and maintain short- and long-term diabetes outcomes, emerging adults are reported to have poor clinic attendance and in turn low participation in diabetes self-management education and support services. This pilot study aims to test a novel approach to diabetes self-management education and support that incorporates technological and applied learning-driven methods delivered through group telemedicine visits to improve emerging adults engagement in diabetes self-management education and support with the ultimate goal of improving diabetes outcomes.
Detailed description
Diabetes self-management education and support is considered a cornerstone of care and essential in helping people navigate self-management decisions and activities. Despite evidence that diabetes self-management education and support is a critical component of diabetes care, participation remains low. Emerging adulthood has been described as the distinct period between 18 and 25 years when adolescents work to achieve autonomy and explore life possibilities in moving toward adulthood. Suboptimal self-management has been identified as a major problem in emerging adults with type 1 diabetes, a particularly vulnerable group with an increased risk for poor diabetes-related outcomes. In its current form diabetes self-management education and support has been cited for not meeting the needs of emerging adults, when emerging adults have expressed interest in diabetes self-management education and support delivered with peer-supported, technological and applied learning-driven methods. To address these challenges, we are applying information gained from the literature and key stakeholder groups to our established Telemedicine for Reach, Education, Access and Treatment (TREAT) delivery model with a specific focus on diabetes self-management education and support. TREAT-ED (for self-management EDucation) will be designed to specifically engage emerging adults by integrating diabetes self-management education and support objectives to support informed decision making, self-care, and preparation for transfer to adult care, to improve outcomes. Diabetes care and education specialists will lead TREAT-ED with a cohort of emerging adults and will 1) help to organize and facilitate group sessions delivered through telehealth and 2) use continuous blood glucose monitoring reports as personalized examples to drive established diabetes self-management education and support content. With user-centered design techniques we developed and built and will now evaluate implementation determinants and test the TREAT-ED model. Feasibility assessment of the impact of the model on emerging adult patient participation in diabetes self-management education and support along with clinical, psychosocial and behavioral outcomes will be examined. We hypothesize that models that rely on current day strategies to engage emerging adults at high risk for diabetes-related problems with effective self-management skills will improve diabetes self-management education and support engagement and outcomes. If proven to be effective, this model is one that could be adapted for emerging adults who have transferred to adult diabetes care and other patient populations throughout the United States.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TREAT-ED | Experimental | Other: TREAT-ED Virtual Group Diabetes Self-Management Education and Support* Emerging adult patients with type 1 diabetes assigned to groups of eight participants on average. * Four diabetes self-management education and support group sessions delivered virtually each session lasting 30-45 minutes. * Group sessions scheduled at intervals decided up on by participants. |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Diagnosed with type 1 diabetes (ICD10 E10.xx, O24.0x)
- 18 to 26 years of age at time of study enrollment
- Able to communicate via videoconferencing platform
- Intending to maintain status as a patient at participating clinical sites throughout the study duration
- Able to provide informed consent
Key exclusion criteria (5 listed)
- Do not have a diagnosis of type 1 diabetes (ICD10 E10.xx, O24.0x)
- Less than 18 or older than 26 years old at time of enrollment
- Do not intend to maintain their care at participating clinical sites throughout the duration of the study
- Are unable to communicate via telemedicine
- Has other concerns that may interfere significantly with their ability to participate in the intervention (ongoing health issues, personal events, etc.)
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 |
|---|---|---|
| TREAT-ED Virtual Group Diabetes Self-Management Education and SupportTREAT-ED is an innovative group telehealth delivery model designed to engage emerging adults in DSMES services. TREAT-ED sessions are facilitated by a Diabetes Care and Education Specialist and include content centered around the ADCES7 Self-Care Behaviors and applied learning strategies, e.g., case scenarios integrating glucose monitoring, and group discussions to drive knowledge transfer and skill development for diabetes self-care behaviors within the context of issues that are salient to the target population. | Other | TREAT-ED |
Primary outcome
Number of diabetes self-management education and support sessions attended
Time frame: From baseline to 6 months
Possible range is 0 to 4 sessions.
8 secondary outcomes
Change from baseline in empowerment at 6 months
Time frame: Baseline vs. 6 months
Change from baseline in readiness for transition at 6 months
Time frame: Baseline vs. 6 months
Change from baseline in self-efficacy at 6 months
Time frame: Baseline vs. 6 months
Change from baseline in diabetes distress at 6 months
Time frame: Baseline vs. 6 months
Change in percentage of patients with glycemic control from baseline to 6 months.
Time frame: Baseline vs. 6 months
Percentage of time in target glycemic range (70-180 mg/dL)
Time frame: From baseline to 6 months
Number of acute care visits
Time frame: From baseline to 6 months
Number of diabetes clinic visits attended
Time frame: From baseline to 6 months
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 22 Jun 2026.
- Individual participant dataSharing planned: Yes. De-identified IPD that underlies results reported in publication.
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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.
Ingrid Libman, MD, PhD principal investigator
University of Pittsburgh
Linda Siminerio, RN, PhD, CDCES principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TREAT-ED Virtual Group Diabetes Self-Management Education and Support in people with Type 1 Diabetes (T1D), run by University of Pittsburgh 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 5 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 22 Jun 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?
Number of diabetes self-management education and support sessions attended (time frame: From baseline to 6 months). 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 22 Jun 2026.