Type 2 DiabetesNCT07032844
Advancing Diabetes Management for People With Physical Disabilities Optimally Through Primary Care-Based Telehealth (ADDOPT)
A study testing Digital Health Coaching and Continuous Glucose Monitoring Teleconsults in people with Type 2 Diabetes, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The purpose of the study is to compare 2 primary care based telehealth interventions- 1) digital health coaching and 2) remote patient monitoring for improving glycemic (blood sugar levels) control and overall health outcomes in individuals with physical disabilities, type 2 diabetes (T2DM) and at least one chronic… Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Digital Health Coaching and Continuous Glucose Monitoring Teleconsults
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,000 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jul 2026to 31 Jan 2028
- 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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Physical Disability
- Diagnosed with Type 2 Diabetes
- Hemoglobin A1c ≥7% within 3 months of screening
- Must have at least 1 additional chronic conditions from the list below Hypertension Congestive Heart Failure Coronary Artery Disease Hyperlipidemia Stroke Arthritis Asthma Cancer Chronic Kidney Disease (Stages 1-4) COPD Osteoporosis Multiple Sclerosis Parkinsons
Who cannot join
- Intellectual, Learning, Developmental Disabilities
- Non-english speakers
- Currently pregnant
- Significant vision loss preventing use of phone/tablet for interventions
- Received Remote Patient Monitoring or Digital Health Coaching for T2DM management within 30 days of enrollment
- End-stage kidney disease (on dialysis)
- Does not report having a physical disability
- Perceived unwillingness or inability to participate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UAB Highlands Hospital/Department of Family and Community Medicine
Birmingham, Alabama, 35223
Aseel El Zein Research Scientist, PhD, RDN, 2052011507, assil.elzein352@gmail.com
About this study
Official title: Comparing the Effectiveness of Primary Care Delivered Telehealth Interventions to Manage Type 2 Diabetes in People With Physical Disabilities and Multiple Chronic Conditions
The purpose of the study is to compare 2 primary care based telehealth interventions- 1) digital health coaching and 2) remote patient monitoring for improving glycemic (blood sugar levels) control and overall health outcomes in individuals with physical disabilities, type 2 diabetes (T2DM) and at least one chronic condition. The project aims to determine which intervention is more effective in reducing blood sugar levels, improving patient-reported outcomes such as diabetes-related distress, and facilitating the implementation of these approaches in real-world primary care settings serving vulnerable populations. The findings intend to inform about optimal telehealth strategies for managing multiple chronic conditions in underserved groups, there by supporting improved health equity and quality of care.
Read the detailed description
The Centers for Disease Control and Prevention (CDC) defines chronic diseases as conditions that last one year or more and require ongoing medical attention, limit activities of daily living, or both. Six in 10 adults in the U.S. are reported to have at least one chronic condition, while four in 10 adults in the U.S. are reported to have two or more chronic conditions.T2DM is one of the chronic conditions in the U.S. population that has been gradually increasing over the years. Over 34.2 million U.S. adults are affected by diabetes mellitus (DM); T2DM accounts for 90-95% of these.T2DM is often associated with other cardiometabolic diseases such as hypertension and obesity.T2DM is one of the strongest risk factors for cardiovascular disease (CVD) and chronic kidney disease (CKD), which are among the leading causes of death in the U.S. T2DM also results in physical disability because of complications such as leg amputation and vision loss.
Individuals with physical disabilities face a disproportionate burden of T2DM and related chronic conditions, exacerbated by suboptimal social determinants of health (SDoH) such as reduced healthcare access and economic inequities.In general, 50-60% of disparities in T2DM outcomes can be attributed to social determinants of health (SDoH). SDoH are defined as the conditions in which people are born, grow, live, work, and age. Physical disability has an intimate relationship with SDoH such as race/ethnicity, sex, socioeconomic status, geographic location, access to and quality of healthcare, etc. Transformation from the status of able-bodied person to the status of disability leads to a disparity and decline in SDoH of these individuals in terms of geographic location, healthcare access, transportation, economic support, food security, and so on.
Teleheath interventions, including digital health coaching (DHC) and remote patient monitoring(RPM), have emerged as promising strategies to address these disaprtiites, improve glycemic control, and overcome barriers to care. Developing an optimal, interdisciplinary primary care delivery model incorporating digital health coaching or RPM may play a crucial role in overcoming the obstacle of suboptimal patient-physician communication by enhancing both physician and patient satisfaction and improving population health. Both digital health coaching and RPM address SDoH, are being implemented by health systems, and show evidence of effectiveness through trials as well as real-world effectiveness.
However, there exists a clear evidence gap about which of these two interventions are superior and will best optimize population health outcomes. Further, there is an evidence gap about how these telehealth interventions may help people with physical disabilities and multiple chronic conditions and affect their long-term outcomes. The project design addresses this critical gaps identified in earlier research. While both interventions (RPM and DHC) show promise individually, no direct comparisons exist in populations with physical disabilities- a group disproportionally affteced by diabtese and access barriers. Previous studies often excluded this demographic or focused on single chronic conditions, despite evidence that multimorbidity complicates self-management. Aditionally, implementation science gaps presists regarding workflow integration in real-world primary car settings serving vulnerable groups.
- Conditions
- Type 2 Diabetes
- Being tested
- Digital Health Coaching, Continuous Glucose Monitoring Teleconsults
- Keywords
- Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Health CoachingBehavioural
This program will be developed using existing, evidence-based curricula for chronic disease self-management. Prior to initiating health coaching with participants, coaches will review data collected related to SDoH to further tailor the intervention as appropriate for housing stability, access to food and transportation, and interpersonal safety. All coaches will have access to participants' EMRs such that they can view medical information throughout the intervention. Coaches will be trained using a curriculum developed by Family and Community Medicine's inter-professional care team and our partners at NCHPAD, making the coaching inclusive of people with physical disabilities, such that the coaches are proficient in motivating behavior change related to resilience, physical activity, nutrition, mindfulness, and relationship-building, among others.
Continuous Glucose Monitoring TeleconsultsBehavioural
This comparator arm consists of continuous glucose monitoring (CGM) with periodic teleconsult visits over 6 months, delivered by trained pharmacists, RDs, or nurses, with devices shipped centrally to participants' homes. Sensors are replaced per manufacturer guidelines. During onboarding, participants receive device education and standardized safety counseling on recognizing and managing hypoglycemia (<70 mg/dL; severe <54 mg/dL) and hyperglycemia (>300 mg/dL), including when to seek urgent or emergency care. During each teleconsult, the CGM team reviews Time in Range, Time Above Range, and Time Below Range, identifies patterns between glucose and lifestyle factors, and supports goal setting and medication adjustments as needed. Participants with repeated missed readings are contacted by the study team to troubleshoot adherence barriers.
| Study group | Role | What they receive |
|---|---|---|
| Digital Health Coaching | Experimental | Participants receive individual digital health coaching by phone: weekly calls for the first 12 weeks addressing goal setting, supportive environments for behavior change, physical activity, and nutrition, followed by biweekly calls for an additional 12 weeks (weeks 13-24) to reinforce habits and advance goals. Receives: Behavioral: Digital Health Coaching |
| Continuous Glucose Monitoring Teleconsults | Experimental | Participants receive continuous glucose monitoring (CGM) with periodic clinician teleconsults over 6 months. Study staff ship a CGM kit (sensor and reader, for participants without a compatible smartphone) to the participant's home; sensors are replaced per manufacturer guidelines. During onboarding, participants receive device education and safety counseling on recognizing and managing hypoglycemia (<70 mg/dL; severe <54 mg/dL) and hyperglycemia (>300 mg/dL). During each teleconsult, the primary care team reviews Time in Range, Time Above Range, and Time Below Range, identifies patterns between glucose and lifestyle factors, and adjusts goals or medications as needed. Receives: Behavioral: Continuous Glucose Monitoring Teleconsults |
| Combination of Digital Health Coaching and CGM-Teleconsults | Experimental | Participants receive both digital health coaching and CGM-teleconsults in an integrated approach. Receives: Behavioral: Digital Health Coaching; Behavioral: Continuous Glucose Monitoring Teleconsults |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hemoglobin A1c
Our primary aim 1 compares the average treatment effectiveness of a six-month RPM, digital health coaching, and combination digital health coaching and RPM program through a multi-site pragmatic randomized trial design. Our primary outcome is reduction in HbA1c at 12 months. Investigators hypothesize that the combination arm will result in superior improvements in HbA1c compared to either intervention alone, aligning with preliminary stakeholder engagement suggesting patient-centered preference for this combined approach.
Measured: 12 months
Secondary outcomes (1)
Diabetes Distress Screening Scale Results
Investigators hypothesize that the combination arm will result in more significant improvements in diabetes distress compared to either the remote patient monitoring (RPM) or digital health coaching alone.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start13 Jul 2026
- Primary completion1 Dec 2027 (estimated)
- Study completion31 Jan 2028 (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 Alabama at BirminghamThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All participants enrolled in the study will receive one of the core interventions: 1. Digital Health coaching 2. Remote Patient Monitoring 3. Combination of Digital Health coaching + Remote Patient Monitoring
- Masking
- None (open label)
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Tapan Shirish Mehta, University of Alabama at Birmingham
- Investigators
- Tapan Mehta, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07032844
- Sponsor's protocol ID
- IRB-300014522
- Other IDs
- TE-2023C3-34949
- Status last verified
- Jul 2026
- First submitted
- 7 Jun 2025
- Last updated
- 6 Oct 2026
- 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 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Effectiveness of Primary Care Delivered Telehealth Interventions to Manage Type 2 Diabetes in People With Physical Disabilities and Multiple Chronic Conditions
- ClinicalTrials.gov ID
- NCT07032844
- Acronym / sponsor ID
- IRB-300014522
- Conditions
- Type 2 Diabetes
- Keywords
- Diabetes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 13 Jul 2026 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 24 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 purpose of the study is to compare 2 primary care based telehealth interventions- 1) digital health coaching and 2) remote patient monitoring for improving glycemic (blood sugar levels) control and overall health outcomes in individuals with physical disabilities, type 2 diabetes (T2DM) and at least one chronic condition. The project aims to determine which intervention is more effective in reducing blood sugar levels, improving patient-reported outcomes such as diabetes-related distress, and facilitating the implementation of these approaches in real-world primary care settings serving vulnerable populations. The findings intend to inform about optimal telehealth strategies for managing multiple chronic conditions in underserved groups, there by supporting improved health equity and quality of care.
Detailed description
The Centers for Disease Control and Prevention (CDC) defines chronic diseases as conditions that last one year or more and require ongoing medical attention, limit activities of daily living, or both. Six in 10 adults in the U.S. are reported to have at least one chronic condition, while four in 10 adults in the U.S. are reported to have two or more chronic conditions.T2DM is one of the chronic conditions in the U.S. population that has been gradually increasing over the years. Over 34.2 million U.S. adults are affected by diabetes mellitus (DM); T2DM accounts for 90-95% of these.T2DM is often associated with other cardiometabolic diseases such as hypertension and obesity.T2DM is one of the strongest risk factors for cardiovascular disease (CVD) and chronic kidney disease (CKD), which are among the leading causes of death in the U.S. T2DM also results in physical disability because of complications such as leg amputation and vision loss.
Individuals with physical disabilities face a disproportionate burden of T2DM and related chronic conditions, exacerbated by suboptimal social determinants of health (SDoH) such as reduced healthcare access and economic inequities.In general, 50-60% of disparities in T2DM outcomes can be attributed to social determinants of health (SDoH). SDoH are defined as the conditions in which people are born, grow, live, work, and age. Physical disability has an intimate relationship with SDoH such as race/ethnicity, sex, socioeconomic status, geographic location, access to and quality of healthcare, etc. Transformation from the status of able-bodied person to the status of disability leads to a disparity and decline in SDoH of these individuals in terms of geographic location, healthcare access, transportation, economic support, food security, and so on.
Teleheath interventions, including digital health coaching (DHC) and remote patient monitoring(RPM), have emerged as promising strategies to address these disaprtiites, improve glycemic control, and overcome barriers to care. Developing an optimal, interdisciplinary primary care delivery model incorporating digital health coaching or RPM may play a crucial role in overcoming the obstacle of suboptimal patient-physician communication by enhancing both physician and patient satisfaction and improving population health. Both digital health coaching and RPM address SDoH, are being implemented by health systems, and show evidence of effectiveness through trials as well as real-world effectiveness.
However, there exists a clear evidence gap about which of these two interventions are superior and will best optimize population health outcomes. Further, there is an evidence gap about how these telehealth interventions may help people with physical disabilities and multiple chronic conditions and affect their long-term outcomes. The project design addresses this critical gaps identified in earlier research. While both interventions (RPM and DHC) show promise individually, no direct comparisons exist in populations with physical disabilities- a group disproportionally affteced by diabtese and access barriers. Previous studies often excluded this demographic or focused on single chronic conditions, despite evidence that multimorbidity complicates self-management. Aditionally, implementation science gaps presists regarding workflow integration in real-world primary car settings serving vulnerable groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- All participants enrolled in the study will receive one of the core interventions: 1. Digital Health coaching 2. Remote Patient Monitoring 3. Combination of Digital Health coaching + Remote Patient Monitoring
| Arm | Type | Receives |
|---|---|---|
| Digital Health Coaching | Experimental | Behavioral: Digital Health CoachingParticipants receive individual digital health coaching by phone: weekly calls for the first 12 weeks addressing goal setting, supportive environments for behavior change, physical activity, and nutrition, followed by biweekly calls for an additional 12 weeks (weeks 13-24) to reinforce habits and advance goals. |
| Continuous Glucose Monitoring Teleconsults | Experimental | Behavioral: Continuous Glucose Monitoring TeleconsultsParticipants receive continuous glucose monitoring (CGM) with periodic clinician teleconsults over 6 months. Study staff ship a CGM kit (sensor and reader, for participants without a compatible smartphone) to the participant's home; sensors are replaced per manufacturer guidelines. During onboarding, participants receive device education and safety counseling on recognizing and managing hypoglycemia (<70 mg/dL; severe <54 mg/dL) and hyperglycemia (>300 mg/dL). During each teleconsult, the primary care team reviews Time in Range, Time Above Range, and Time Below Range, identifies patterns between glucose and lifestyle factors, and adjusts goals or medications as needed. |
| Combination of Digital Health Coaching and CGM-Teleconsults | Experimental | Behavioral: Digital Health Coaching, Behavioral: Continuous Glucose Monitoring TeleconsultsParticipants receive both digital health coaching and CGM-teleconsults in an integrated approach. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Physical Disability
- Diagnosed with Type 2 Diabetes
- Hemoglobin A1c ≥7% within 3 months of screening
- Must have at least 1 additional chronic conditions from the list below Hypertension Congestive Heart Failure Coronary Artery Disease Hyperlipidemia Stroke Arthritis Asthma Cancer Chronic Kidney Disease (Stages 1-4) COPD Osteoporosis Multiple Sclerosis Parkinsons
Key exclusion criteria (8 listed)
- Intellectual, Learning, Developmental Disabilities
- Non-english speakers
- Currently pregnant
- Significant vision loss preventing use of phone/tablet for interventions
- Received Remote Patient Monitoring or Digital Health Coaching for T2DM management within 30 days of enrollment
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 |
|---|---|---|
| Digital Health CoachingThis program will be developed using existing, evidence-based curricula for chronic disease self-management. Prior to initiating health coaching with participants, coaches will review data collected related to SDoH to further tailor the intervention as appropriate for housing stability, access to food and transportation, and interpersonal safety. All coaches will have access to participants' EMRs such that they can view medical information throughout the intervention. Coaches will be trained using a curriculum developed by Family and Community Medicine's inter-professional care team and our partners at NCHPAD, making the coaching inclusive of people with physical disabilities, such that the coaches are proficient in motivating behavior change related to resilience, physical activity, nutrition, mindfulness, and relationship-building, among others. | Behavioural | Combination of Digital Health Coaching and CGM-Teleconsults, Digital Health Coaching |
| Continuous Glucose Monitoring TeleconsultsThis comparator arm consists of continuous glucose monitoring (CGM) with periodic teleconsult visits over 6 months, delivered by trained pharmacists, RDs, or nurses, with devices shipped centrally to participants' homes. Sensors are replaced per manufacturer guidelines. During onboarding, participants receive device education and standardized safety counseling on recognizing and managing hypoglycemia (<70 mg/dL; severe <54 mg/dL) and hyperglycemia (>300 mg/dL), including when to seek urgent or emergency care. During each teleconsult, the CGM team reviews Time in Range, Time Above Range, and Time Below Range, identifies patterns between glucose and lifestyle factors, and supports goal setting and medication adjustments as needed. Participants with repeated missed readings are contacted by the study team to troubleshoot adherence barriers. | Behavioural | Combination of Digital Health Coaching and CGM-Teleconsults, Continuous Glucose Monitoring Teleconsults |
Primary outcome
Change in Hemoglobin A1c
Time frame: 12 months
Our primary aim 1 compares the average treatment effectiveness of a six-month RPM, digital health coaching, and combination digital health coaching and RPM program through a multi-site pragmatic randomized trial design. Our primary outcome is reduction in HbA1c at 12 months. Investigators hypothesize that the combination arm will result in superior improvements in HbA1c compared to either intervention alone, aligning with preliminary stakeholder engagement suggesting patient-centered preference for this combined approach.
1 secondary outcome
Diabetes Distress Screening Scale Results
Time frame: 12 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 6 Oct 2026.
- 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.
Tapan Mehta, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Health Coaching and Continuous Glucose Monitoring Teleconsults in people with Type 2 Diabetes, run by University of Alabama at Birmingham 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 4 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 6 Oct 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?
Contact Aseel El Zein, PhD (205-201-1507, assilelzein@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hemoglobin A1c (time frame: 12 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 6 Oct 2026.