Type 2 DiabetesNCT06740435
Enhancing Telemedicine for T2D
A study testing Enhanced Telemedicine for Type 2 Diabetes and Usual Telemedicine Endocrinology Care for T2D in people with Type 2 Diabetes, run by University of Pittsburgh at 1 site in United States.
Trial summary
The goal of this pilot clinical trial is to assess feasibility of an intervention to deliver comprehensive, high-quality diabetes care through telemedicine among adults with type 2 diabetes who use insulin and have multiple chronic health conditions. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Enhanced Telemedicine for Type 2 Diabetes and Usual Telemedicine Endocrinology Care for T2D
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults 18 years or older
- Diagnosis of type 2 diabetes based on abbreviated ICD-10 code E11.X in medical record or self-report
- HbA1c greater than or equal to 8% based on most recent value at time of recruitment
- Patients must own or have access to a smart phone, tablet, or home computer with data or internet connection that allows access to video-based visits
- Patient must use insulin
- Patients must have >2 comorbid chronic health conditions
- Be able to provide informed consent
- Reside in Pennsylvania
Who cannot join
- Age over 80 based on date of birth in electronic medical record
- Visit with an endocrinologist in the prior 1 years
- Dementia, ESRD, malignancy based on abbreviated ICD-10 codes below in medical record or self-report of associated condition
- Dementia: A81.0x, F01.5x, F02.8x, F03.9x, F10.27, F10.97, F13.27, F13.97, F18.97, F19.17, F19.27, F19.97, G30.x, G31.0x, G31.1, G31.83, G31.85
- Malignancy, except non-melanoma skin cancer: C00.x-C14.x, C15.x-C26.x, C3x.xx, C40.xx-C41.x, C43.x, C4A.xx, C45.x-C49.xx, C50.xxx, C51.x-C58, C60.x-C63.x, C64.x- C68.x, C69.xx-C72.x, C73-C76.x, C7A.xx, C80.xx-C96.x (except C90.x1, C91.x1, C92.x1, C93.x1, C94.x1, C95.x1)
- ESRD N18.6
Show all 12Show fewer
- Type 1, gestational, or other diabetes based on abbreviated ICD-10 codes below in medical record or self-report of associated condition
- Type 1 diabetes: E10.X
- Gestational diabetes: O24.X, E08.X
- Other diabetes: E09.X, E13.2
- Pregnant or planning to become pregnant in next 6 months
- Currently enrolled in another diabetes management intervention study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Pilot Study Enhancing Telemedicine Care Delivery for Adults With Complex Type 2 Diabetes
The goal of this pilot clinical trial is to assess feasibility of an intervention to deliver comprehensive, high-quality diabetes care through telemedicine among adults with type 2 diabetes who use insulin and have multiple chronic health conditions. The main question it aims to answer is:
Is an enhanced telemedicine intervention for type 2 diabetes compared to usual telemedicine care feasible?
Read more
Researchers will compare the enhanced telemedicine intervention to usual telemedicine care to see if there are differences in patient satisfaction or preliminary clinical outcomes.
Participants will complete 2-3 telemedicine diabetes care visits over approximately 6 months, as well as complete survey measures with each diabetes care visit. Patients in the intervention group will also receive additional support, including pre-visit preparation phone calls, diabetes self-management education and support aligned with their visits, and post-visit follow-up calls.
Read the detailed description
This pilot study will compare an intervention to deliver high-quality diabetes care through telemedicine for adults with type 2 diabetes who have additional chronic health conditions and use insulin with usual telemedicine care. The investigators will assess feasibility, patient satisfaction, and preliminary clinical outcomes.
Fifty adults will be recruited from primary care practices. Once patients are confirmed eligible, they will be consented and enrolled. Patients will be randomized to the intervention arm or usual telemedicine care, stratified by age (above or below 65 years) and rurality, as these factors are associated with technological literacy and broadband access, which may impact telemedicine use and outcomes. Both groups will complete baseline survey measures and baseline clinical data will be collected via chart review. As this is a pragmatic pilot trial, intervention components will be delivered by usual clinical providers and staff for the intervention group. The telemedicine care intervention will include 2-3 synchronous visits with endocrinology providers over 6 months plus additional visits with multidisciplinary providers on an individualized basis. Telemedicine care will proceed as usual for the control group.
The investigators will focus pilot trial outcomes on standard metrics to assess feasibility for a future large trial. The investigators will also measure preliminary clinical outcomes.
- Conditions
- Type 2 Diabetes
- Being tested
- Enhanced Telemedicine for Type 2 Diabetes, Usual Telemedicine Endocrinology Care for T2D
- Keywords
- Telemedicine
- 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.
Enhanced Telemedicine for Type 2 DiabetesOther
Telemedicine-based endocrinology specialty care for type 2 diabetes with multidisciplinary diabetes care team support including pre-visit preparation, in-visit support and self-management education, and post-visit follow-up.
Usual Telemedicine Endocrinology Care for T2DOther
Routine telemedicine-based endocrinology specialty care for type 2 diabetes, generally consisting of synchronous virtual visit with an endocrinologist and additional support including self-management education on an individualized basis.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Telemedicine Care | Experimental | Specialty care for type 2 diabetes delivered via telemedicine by an endocrinologist, with additional multidisciplinary support from the diabetes care team. Receives: Other: Enhanced Telemedicine for Type 2 Diabetes |
| Usual Care | Active comparator | Specialty care for type 2 diabetes delivered via telemedicine by an endocrinologist following usual clinical care protocols. Receives: Other: Usual Telemedicine Endocrinology Care for T2D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment percentage
Percent of eligible patients approached who are enrolled
Measured: 12 months
Loss to follow up
Percent of enrolled patients who do not complete study, defined as not completing at least 2 study visits and associated surveys
Measured: 6 months
Secondary outcomes (16)
Recruitment rate
Number of patients recruited per month
Measured: 12 months
Eligibility percentage
Percent of patients approached who are eligible
Measured: 12 months
Visit attendance
Percent of scheduled visits completed per patient
Measured: 6 months
Number of between-visit contacts
Number of successful and attempted patient contacts by clinicians between visits per patient
Measured: 6 months
Blood glucose data availability
Number of telemedicine visits with blood glucose data available at visit per patient
Measured: 6 months
Patient satisfaction with telemedicine diabetes care
Percent of patients reporting satisfied or very satisfied on a 5-point Likert scale ranging from 1 "strongly disagree" to 5 "strongly agree" with the statement "Overall, I am satisfied with the quality of service being provided via telemedicine" with higher scores indicating greater satisfaction
Measured: 6 months
Diabetes Treatment Satisfaction Questionnaire-static version
Total score of 8-item measure of global satisfaction with diabetes treatment regimen. The static version will be used at baseline. Items 1, 4, 5, 6, 7 \& 8 are summed to produce a Treatment Satisfaction score (range:0 to 36). The higher the score, the greater the satisfaction with treatment. 'Perceived frequency of hyperglycaemia' (item 2) \& 'Perceived frequency of hypoglycaemia' (item 3): Both rated: 6 ('most of the time') to 0 ('none of the time'). Here, lower scores indicate blood glucose levels closer to the ideal. Higher scores indicate problems.
Measured: Baseline
Diabetes Treatment Satisfaction Questionnaire-change version
Total score of 8-item measure of global satisfaction with diabetes treatment regimen. The change version will be used at 6 months.Items 1, 4, 5, 6, 7 and 8 are summed to produce a Treatment Satisfaction (change) score (range: +18 to -18). The higher the score, the greater the improvement in satisfaction with treatment; the lower the score, the greater the deterioration in satisfaction with treatment. A score of 0 represents no change. Two remaining items ('Perceived change in frequency of hyperglycaemia' (item 2) and 'Perceived change in frequency of hypoglycaemia' (item 3)) are treated individually: Both rated: +3 ('much more of the time now') to -3 ('much less of the time now').
Here, negative scores indicate fewer problems with blood glucose levels. Positive scores indicate more problems than before.
Measured: 6 months
T2D Diabetes Distress Core Scale
Change in total score of 8-item measure of diabetes-related distress over prior month from baseline to 6 months. The Diabetes Distress Core scale is scored by averaging the value for each item, ranked from 1 to 5 scale (score range 1-5), with higher scores indicating more distress.
Measured: Baseline and 6 months
HbA1c change
Change in glycemic control from baseline to 6 months
Measured: Baseline and 6 months
Prescription of guideline-based GLP-1 receptor agonist
Number of patients with indications for GLP-1 receptor agonist therapy who are prescribed the indicated medication
Measured: Baseline and 6 months
Prescription of guideline-based SGLT2 inhibitor
Number of patients with indications for SGLT2 inhibitor therapy who are prescribed the indicated medication
Measured: Baseline and 6 months
Retinal examination
Number of patients with documentation of retinal examination performed in last year in medical record
Measured: 6 months
Urine protein testing
Number of patients with documentation of urine protein testing performed in last year in medical record
Measured: 6 months
Immunization-pneumococcal
Number of patients with documentation of pneumococcal vaccination in medical record
Measured: 6 months
Immunization-influenza
Number of patients with documentation of influenza vaccination in medical record
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start3 Feb 2025
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Margaret Zupa, University of Pittsburgh
- Investigators
- Margaret Zupa, MDMS, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06740435
- Sponsor's protocol ID
- STUDY24060062
- Other IDs
- K23DK135794
- Status last verified
- Jun 2026
- First submitted
- 13 Dec 2024
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A deidentified dataset including limited demographic, encounter, laboratory result, clinical observations, medication orders, care utilization, and survey (intervention satisfaction, treatment satisfaction, diabetes distress) data will be created. To protect research participant identities, datasets will not include any potentially identifying participant information.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Enhancing Telemedicine Care Delivery for Adults With Complex Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT06740435
- Acronym / sponsor ID
- STUDY24060062
- Conditions
- Type 2 Diabetes
- Keywords
- Telemedicine
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 18 Dec 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.
The goal of this pilot clinical trial is to assess feasibility of an intervention to deliver comprehensive, high-quality diabetes care through telemedicine among adults with type 2 diabetes who use insulin and have multiple chronic health conditions. The main question it aims to answer is:
Is an enhanced telemedicine intervention for type 2 diabetes compared to usual telemedicine care feasible?
Researchers will compare the enhanced telemedicine intervention to usual telemedicine care to see if there are differences in patient satisfaction or preliminary clinical outcomes.
Participants will complete 2-3 telemedicine diabetes care visits over approximately 6 months, as well as complete survey measures with each diabetes care visit. Patients in the intervention group will also receive additional support, including pre-visit preparation phone calls, diabetes self-management education and support aligned with their visits, and post-visit follow-up calls.
Detailed description
This pilot study will compare an intervention to deliver high-quality diabetes care through telemedicine for adults with type 2 diabetes who have additional chronic health conditions and use insulin with usual telemedicine care. The investigators will assess feasibility, patient satisfaction, and preliminary clinical outcomes.
Fifty adults will be recruited from primary care practices. Once patients are confirmed eligible, they will be consented and enrolled. Patients will be randomized to the intervention arm or usual telemedicine care, stratified by age (above or below 65 years) and rurality, as these factors are associated with technological literacy and broadband access, which may impact telemedicine use and outcomes. Both groups will complete baseline survey measures and baseline clinical data will be collected via chart review. As this is a pragmatic pilot trial, intervention components will be delivered by usual clinical providers and staff for the intervention group. The telemedicine care intervention will include 2-3 synchronous visits with endocrinology providers over 6 months plus additional visits with multidisciplinary providers on an individualized basis. Telemedicine care will proceed as usual for the control group.
The investigators will focus pilot trial outcomes on standard metrics to assess feasibility for a future large trial. The investigators will also measure preliminary clinical outcomes.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced Telemedicine Care | Experimental | Other: Enhanced Telemedicine for Type 2 DiabetesSpecialty care for type 2 diabetes delivered via telemedicine by an endocrinologist, with additional multidisciplinary support from the diabetes care team. |
| Usual Care | Active comparator | Other: Usual Telemedicine Endocrinology Care for T2DSpecialty care for type 2 diabetes delivered via telemedicine by an endocrinologist following usual clinical care protocols. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- adults 18 years or older
- Diagnosis of type 2 diabetes based on abbreviated ICD-10 code E11.X in medical record or self-report
- HbA1c greater than or equal to 8% based on most recent value at time of recruitment
- Patients must own or have access to a smart phone, tablet, or home computer with data or internet connection that allows access to video-based visits
- Patient must use insulin
Key exclusion criteria (12 listed)
- Age over 80 based on date of birth in electronic medical record
- Visit with an endocrinologist in the prior 1 years
- Dementia, ESRD, malignancy based on abbreviated ICD-10 codes below in medical record or self-report of associated condition
- Type 1, gestational, or other diabetes based on abbreviated ICD-10 codes below in medical record or self-report of associated condition
- Pregnant or planning to become pregnant in next 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 |
|---|---|---|
| Enhanced Telemedicine for Type 2 DiabetesTelemedicine-based endocrinology specialty care for type 2 diabetes with multidisciplinary diabetes care team support including pre-visit preparation, in-visit support and self-management education, and post-visit follow-up. | Other | Enhanced Telemedicine Care |
| Usual Telemedicine Endocrinology Care for T2DRoutine telemedicine-based endocrinology specialty care for type 2 diabetes, generally consisting of synchronous virtual visit with an endocrinologist and additional support including self-management education on an individualized basis. | Other | Usual Care |
Primary outcome
Recruitment percentage
Time frame: 12 months
Percent of eligible patients approached who are enrolled
Loss to follow up
Time frame: 6 months
Percent of enrolled patients who do not complete study, defined as not completing at least 2 study visits and associated surveys
16 secondary outcomes
Recruitment rate
Time frame: 12 months
Eligibility percentage
Time frame: 12 months
Visit attendance
Time frame: 6 months
Number of between-visit contacts
Time frame: 6 months
Blood glucose data availability
Time frame: 6 months
Patient satisfaction with telemedicine diabetes care
Time frame: 6 months
Diabetes Treatment Satisfaction Questionnaire-static version
Time frame: Baseline
Diabetes Treatment Satisfaction Questionnaire-change version
Time frame: 6 months
T2D Diabetes Distress Core Scale
Time frame: Baseline and 6 months
HbA1c change
Time frame: Baseline and 6 months
Prescription of guideline-based GLP-1 receptor agonist
Time frame: Baseline and 6 months
Prescription of guideline-based SGLT2 inhibitor
Time frame: Baseline and 6 months
Retinal examination
Time frame: 6 months
Urine protein testing
Time frame: 6 months
Immunization-pneumococcal
Time frame: 6 months
Immunization-influenza
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Individual participant dataSharing planned: Yes. A deidentified dataset including limited demographic, encounter, laboratory result, clinical observations, medication orders, care utilization, and survey (intervention satisfaction, treatment satisfaction, diabetes distress) data will be created. To protect research participant identities, datasets will not include any potentially identifying participant information.
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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.
Margaret Zupa, MDMS 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 Enhanced Telemedicine for Type 2 Diabetes and Usual Telemedicine Endocrinology Care for T2D in people with Type 2 Diabetes, 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 8 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 5 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?
This study is still under way. Results are not available in the source record yet.
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?
Recruitment percentage (time frame: 12 months). The study lists 2 primary outcomes in all. 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 5 Jun 2026.