Diabetes Mellitus, Type 2NCT03590041
Comparative Effectiveness of Diabetes Shared Medical Appointment Models
A study testing Standardized SMA and Patient-driven SMA in people with Diabetes Mellitus, Type 2, run by University of Colorado, Denver at 1 site in United States.
Trial summary
In this study, the investigators will compare the effectiveness of patient-driven diabetes Shared Medical Appointments (SMAs) to standardized diabetes SMAs. The curriculum to be used is Targeted Training for Illness Management (TTIM), a 6-session modular group intervention for chronic illness self-management, and has… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Standardized SMA and Patient-driven SMA
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,085 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2019to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be:
- at least 18 years old,
- have Type II Diabetes, and
- receive care in a participating practice.
- For a practice to be eligible, they must be;
- a Federally Qualified Health Center,
Show all 11Show fewer
- a private primary care practice, or
- Community Mental Health Center with primary care,
- They need to have
- a current panel of at least 150 adult patients with Type 2 Diabetes, and
- access to health educators, Behavioral Health Professionals, and diabetes peer mentors.
Who cannot join
- Are currently pregnant or plan to become pregnant in the next six months,
- Have limited cognitive ability due to dementia or a developmental disorder,
- Less than one year of life expectancy, or
- Plan to leave the area in the next year.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
Official title: Invested in Diabetes: Comparing Patient-Centered Outcomes of Standardized Versus Patient-Driven Diabetes Shared Medical Appointments (PCORI IHS-1609-36322)
In this study, the investigators will compare the effectiveness of patient-driven diabetes Shared Medical Appointments (SMAs) to standardized diabetes SMAs. The curriculum to be used is Targeted Training for Illness Management (TTIM), a 6-session modular group intervention for chronic illness self-management, and has been tested in diabetes. The standardized group visit model will consist of diabetes SMAs with the full TTIM 6-session curriculum, led by a health educator.
Read the detailed description
Type II Diabetes is a prevalent chronic disease with poor outcomes, and requires daily self-care, including blood glucose monitoring, following a diabetes-friendly diet, engaging in regular physical activity, and medication adherence. Patients with diabetes benefit from comprehensive diabetes self-management education (DSME) and self-management support (SMS) in primary care. Shared medical appointments (SMAs) are one way to efficiently and effectively provide DSME and SMS. SMAs can have a variety of different features, but it is not known which features are most effective for which types of patients. Patients and other stakeholders engaged in planning this study proposed a model with "diabetes' veterans" (i.e., diabetes peer mentors) who co-facilitating group visits with a variety of diabetes care professionals, and then working one-on-one with patients to help apply what they learned. The group visit curriculum should include topics on physical activity, healthy eating, taking medication, acceptance and coping, and social support, and each cohort of patients should get to select topics most relevant to them. The practice stakeholders want to do more comprehensive group visit models, but need to know the extent to which SMA participation and patient-centered outcomes are improved compared to the more common standardized approaches they tend to use now.
In this study, the investigators will compare the effectiveness of patient-driven diabetes SMAs to standardized diabetes SMAs. The curriculum to be used is Targeted Training for Illness Management (TTIM), a 6-session modular group intervention for chronic illness self-management, and has been tested in diabetes. The standardized group visit model will consist of diabetes SMAs with the full TTIM 6-session curriculum, led by a health educator. For the patient-driven SMAs, patients choose the topics and the order of sessions from the TTIM curriculum, which is delivered collaboratively by the multidisciplinary care team consisting of several professional providers (health educator, medical provider, and behavioral health provider) and a lay worker (diabetes peer mentor). The primary patient-centered outcome, selected by patient stakeholders, is diabetes distress. Secondary outcomes include autonomy support and diabetes self-management behaviors, clinical outcomes (hemoglobin A1c, blood pressure, and body mass index), patient reach and engagement, and practice-level value and sustainability. Patient, caregiver, practice, health plans, and research stakeholders will be engaged in all aspects of the research. Patients and other stakeholders will inform the process of implementation of patient-driven and standardized SMAs, help finalize the research protocol (including data collection and recruitment), and contribute to interpretation of findings and dissemination of findings, including messages that help other patients make decisions about whether or not to participate in SMAs.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Standardized SMA, Patient-driven SMA
- Keywords
- Diabetes Mellitus Type 2, Comparative Effectiveness Trial
- 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.
Standardized SMABehavioural
Patients receiving the Standardized SMA intervention will be part of group visits that cover a modified TTIM 6-session curriculum, delivered only by health educators. The Standardized SMA approach will be uniformly administered at each practice. Topics will be covered in a predetermined order and patients will not have a say in terms of what content they wish to cover. Patients receive the Standardized SMA approach if their practice is randomly assigned to the Standardized SMA arm. Practices are cluster-randomized to deliver a standardized or patient-driven group visit model.
Patient-driven SMABehavioural
Patients receiving the Patient-driven SMA intervention will be part of group visits that cover a modified TTIM 6-session curriculum, but patients are in control of time spent and order of the topics. The Patient-driven SMA will be delivered by a multidisciplinary team consisting of a Health Educator, medical provider, Behavioral Health Professional, and a diabetes peer mentor. Patient-driven SMAs may be delivered differently at each practice, as patients choose the topics that are most important to spend the most time on. All topics will be covered, but the order and time spent is up to the group. Patients receive the Patient-driven SMA approach if their practice is randomly assigned to that arm. Practices are cluster-randomized to deliver a standardized or patient-driven SMA model.
| Study group | Role | What they receive |
|---|---|---|
| Standardized SMA | Active comparator | The standardized SMA model includes the same TTIM curriculum as in the patient-driven model, but it is delivered in a standardized way (order of and time spent on topics are set) across all participating practices. Receives: Behavioral: Standardized SMA |
| Patient-driven SMA | Active comparator | In the patient-driven SMA model, patients receive the same TTIM curriculum, but patients at each practice are able to set the order of the curriculum and dictate how long to spend on each topic. Receives: Behavioral: Patient-driven SMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetes Distress - Change in Patient Reported Outcomes (PROs)
Comparison of change in patient-reported outcomes around diabetes distress for patients in either SMA group. Measured by the Diabetes Distress Scale (DDS-17). The DDS-17 measures the worries, concerns and fears among individuals with diabetes over time as they struggle with managing diabetes. The DDS is a 17-item self-report instrument. Each of the 17 items is rated on a 6-point scale from (1) "not a problem" to (6) "a very significant problem." The scale yields an overall distress score based on the average responses for all items.
Average score of < 2.0 = reflects little or no distress Average score between 2.0 and 2.9 = reflects moderate distress Average score > 3.0 = reflects high distress A total score > 2.0 (moderate distress) is considered clinically significant
Measured: At end of 6 group visits (time differs by practice, up to 6 months)
Secondary outcomes (1)
Change in Patient HbA1c
Comparison of change in patient HbA1c levels for patients in either SMA group. Measured by Electronic Medical Record data. It evaluates the average amount of glucose in the blood by measuring the percentage of glycated (glycosylated) hemoglobin
Measured: At end of 6 group visits (time differs by practice, up 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 posted18 Jul 2018
- Study start4 Jan 2019
- Primary completion20 Dec 2021
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Model description
- The two interventions are based in the Chronic Care Model, which emphasizes whole person care, addressing physical, mental health and psychosocial needs. The conceptual model underlying patient-driven diabetes Shared Medical Appointments is based on self-determination theory (SDT) and principles of whole person care. According to SDT, human motivation and behavior are a function of the social environment and the extent to which that environment supports basic psychological needs shown to enhance "self-determined motivation."
- Masking
- None (open label)
- Enrolment
- 1,085 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Bethany Kwan, PHD, MSPH, Principal investigator, University of Colorado, DenverJeanette Waxmonsky, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03590041
- Sponsor's protocol ID
- 17-2377
- Status last verified
- Mar 2025
- First submitted
- 15 Jun 2018
- Last updated
- 6 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The Investigators will be sharing results in aggregate form via publications and reports to the funder.
Publications
Holtrop JS, Gurfinkel D, Nederveld A, Reedy J, Rubinson C, Kwan BM. What works in implementing shared medical appointments for patients with diabetes in primary care to enhance reach: a qualitative comparative analysis from the Invested in Diabetes study. Implement Sci Commun. 2024 Jul 24;5(1):82. doi: 10.1186/s43058-024-00608-6.
PubMed 39049078Kwan BM, Dickinson LM, Dailey-Vail J, Glasgow RE, Gritz RM, Gurfinkel D, Hester CM, Holtrop JS, Hosokawa P, Lanigan A, Nease DE Jr, Nederveld A, Phimphasone-Brady P, Ritchie ND, Sajatovic M, Wearner R, Begum A, Carter M, Carrigan T, Clay B, Downey D, Koren R, Trujillo SA, Waxmonsky JA. Comparative Effectiveness of Patient-Driven versus Standardized Diabetes Shared Medical Appointments: A Pragmatic Cluster Randomized Trial. J Gen Intern Med. 2024 Nov;39(15):2970-2979. doi: 10.1007/s11606-024-08868-7. Epub 2024 Jun 28.
PubMed 38943014Nederveld A, Phimphasone-Brady P, Gurfinkel D, Waxmonsky JA, Kwan BM, Holtrop JS. Delivering diabetes shared medical appointments in primary care: early and mid-program adaptations and implications for successful implementation. BMC Prim Care. 2023 Feb 17;24(1):52. doi: 10.1186/s12875-023-02006-8.
PubMed 36803773Holtrop JS, Gurfinkel D, Nederveld A, Phimphasone-Brady P, Hosokawa P, Rubinson C, Waxmonsky JA, Kwan BM. Methods for capturing and analyzing adaptations: implications for implementation research. Implement Sci. 2022 Jul 29;17(1):51. doi: 10.1186/s13012-022-01218-3.
PubMed 35906602Glasgow RE, Gurfinkel D, Waxmonsky J, Rementer J, Ritchie ND, Dailey-Vail J, Hosokawa P, Dickinson LM, Kwan BM. Protocol refinement for a diabetes pragmatic trial using the PRECIS-2 framework. BMC Health Serv Res. 2021 Oct 2;21(1):1039. doi: 10.1186/s12913-021-07084-x.
PubMed 34598702Dickinson LM, Hosokawa P, Waxmonsky JA, Kwan BM. The problem of imbalance in cluster randomized trials and the benefits of covariate constrained randomization. Fam Pract. 2021 Jun 17;38(3):368-371. doi: 10.1093/fampra/cmab007. No abstract available.
PubMed 33677530Kwan BM, Dickinson LM, Glasgow RE, Sajatovic M, Gritz M, Holtrop JS, Nease DE Jr, Ritchie N, Nederveld A, Gurfinkel D, Waxmonsky JA. The Invested in Diabetes Study Protocol: a cluster randomized pragmatic trial comparing standardized and patient-driven diabetes shared medical appointments. Trials. 2020 Jan 10;21(1):65. doi: 10.1186/s13063-019-3938-7.
PubMed 31924249
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Invested in Diabetes: Comparing Patient-Centered Outcomes of Standardized Versus Patient-Driven Diabetes Shared Medical Appointments (PCORI IHS-1609-36322)
- ClinicalTrials.gov ID
- NCT03590041
- Acronym / sponsor ID
- 17-2377
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes Mellitus Type 2, Comparative Effectiveness Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,085 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 4 Jan 2019 (actual)
- Primary completion
- 20 Dec 2021 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 18 Jul 2018 (actual)
- Results
- Posted 6 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, the investigators will compare the effectiveness of patient-driven diabetes Shared Medical Appointments (SMAs) to standardized diabetes SMAs. The curriculum to be used is Targeted Training for Illness Management (TTIM), a 6-session modular group intervention for chronic illness self-management, and has been tested in diabetes. The standardized group visit model will consist of diabetes SMAs with the full TTIM 6-session curriculum, led by a health educator.
Detailed description
Type II Diabetes is a prevalent chronic disease with poor outcomes, and requires daily self-care, including blood glucose monitoring, following a diabetes-friendly diet, engaging in regular physical activity, and medication adherence. Patients with diabetes benefit from comprehensive diabetes self-management education (DSME) and self-management support (SMS) in primary care. Shared medical appointments (SMAs) are one way to efficiently and effectively provide DSME and SMS. SMAs can have a variety of different features, but it is not known which features are most effective for which types of patients. Patients and other stakeholders engaged in planning this study proposed a model with "diabetes' veterans" (i.e., diabetes peer mentors) who co-facilitating group visits with a variety of diabetes care professionals, and then working one-on-one with patients to help apply what they learned. The group visit curriculum should include topics on physical activity, healthy eating, taking medication, acceptance and coping, and social support, and each cohort of patients should get to select topics most relevant to them. The practice stakeholders want to do more comprehensive group visit models, but need to know the extent to which SMA participation and patient-centered outcomes are improved compared to the more common standardized approaches they tend to use now.
In this study, the investigators will compare the effectiveness of patient-driven diabetes SMAs to standardized diabetes SMAs. The curriculum to be used is Targeted Training for Illness Management (TTIM), a 6-session modular group intervention for chronic illness self-management, and has been tested in diabetes. The standardized group visit model will consist of diabetes SMAs with the full TTIM 6-session curriculum, led by a health educator. For the patient-driven SMAs, patients choose the topics and the order of sessions from the TTIM curriculum, which is delivered collaboratively by the multidisciplinary care team consisting of several professional providers (health educator, medical provider, and behavioral health provider) and a lay worker (diabetes peer mentor). The primary patient-centered outcome, selected by patient stakeholders, is diabetes distress. Secondary outcomes include autonomy support and diabetes self-management behaviors, clinical outcomes (hemoglobin A1c, blood pressure, and body mass index), patient reach and engagement, and practice-level value and sustainability. Patient, caregiver, practice, health plans, and research stakeholders will be engaged in all aspects of the research. Patients and other stakeholders will inform the process of implementation of patient-driven and standardized SMAs, help finalize the research protocol (including data collection and recruitment), and contribute to interpretation of findings and dissemination of findings, including messages that help other patients make decisions about whether or not to participate in SMAs.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The two interventions are based in the Chronic Care Model, which emphasizes whole person care, addressing physical, mental health and psychosocial needs. The conceptual model underlying patient-driven diabetes Shared Medical Appointments is based on self-determination theory (SDT) and principles of whole person care. According to SDT, human motivation and behavior are a function of the social environment and the extent to which that environment supports basic psychological needs shown to enhance "self-determined motivation."
| Arm | Type | Receives |
|---|---|---|
| Standardized SMA | Active comparator | Behavioral: Standardized SMAThe standardized SMA model includes the same TTIM curriculum as in the patient-driven model, but it is delivered in a standardized way (order of and time spent on topics are set) across all participating practices. |
| Patient-driven SMA | Active comparator | Behavioral: Patient-driven SMAIn the patient-driven SMA model, patients receive the same TTIM curriculum, but patients at each practice are able to set the order of the curriculum and dictate how long to spend on each topic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients must be:
- For a practice to be eligible, they must be;
Key exclusion criteria (4 listed)
- Are currently pregnant or plan to become pregnant in the next six months,
- Have limited cognitive ability due to dementia or a developmental disorder,
- Less than one year of life expectancy, or
- Plan to leave the area in the next year.
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 |
|---|---|---|
| Standardized SMAPatients receiving the Standardized SMA intervention will be part of group visits that cover a modified TTIM 6-session curriculum, delivered only by health educators. The Standardized SMA approach will be uniformly administered at each practice. Topics will be covered in a predetermined order and patients will not have a say in terms of what content they wish to cover. Patients receive the Standardized SMA approach if their practice is randomly assigned to the Standardized SMA arm. Practices are cluster-randomized to deliver a standardized or patient-driven group visit model. | Behavioural | Standardized SMA |
| Patient-driven SMAPatients receiving the Patient-driven SMA intervention will be part of group visits that cover a modified TTIM 6-session curriculum, but patients are in control of time spent and order of the topics. The Patient-driven SMA will be delivered by a multidisciplinary team consisting of a Health Educator, medical provider, Behavioral Health Professional, and a diabetes peer mentor. Patient-driven SMAs may be delivered differently at each practice, as patients choose the topics that are most important to spend the most time on. All topics will be covered, but the order and time spent is up to the group. Patients receive the Patient-driven SMA approach if their practice is randomly assigned to that arm. Practices are cluster-randomized to deliver a standardized or patient-driven SMA model. | Behavioural | Patient-driven SMA |
Primary outcome
Diabetes Distress - Change in Patient Reported Outcomes (PROs)
Time frame: At end of 6 group visits (time differs by practice, up to 6 months)
Comparison of change in patient-reported outcomes around diabetes distress for patients in either SMA group. Measured by the Diabetes Distress Scale (DDS-17). The DDS-17 measures the worries, concerns and fears among individuals with diabetes over time as they struggle with managing diabetes. The DDS is a 17-item self-report instrument. Each of the 17 items is rated on a 6-point scale from (1) "not a problem" to (6) "a very significant problem." The scale yields an overall distress score based on the average responses for all items. Average score of < 2.0 = reflects little or no distress Average score between 2.0 and 2.9 = reflects moderate distress Average score > 3.0 = reflects high distress A total score > 2.0 (moderate distress) is considered clinically significant
1 secondary outcome
Change in Patient HbA1c
Time frame: At end of 6 group visits (time differs by practice, up to 6 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39049078Holtrop JS, Gurfinkel D, Nederveld A, Reedy J, Rubinson C, Kwan BM. What works in implementing shared medical appointments for patients with diabetes in primary care to enhance reach: a qualitative comparative analysis from the Invested in Diabetes study. Implement Sci Commun. 2024 Jul 24;5(1):82. doi: 10.1186/s43058-024-00608-6.
- Derived from this study: PubMed 38943014Kwan BM, Dickinson LM, Dailey-Vail J, Glasgow RE, Gritz RM, Gurfinkel D, Hester CM, Holtrop JS, Hosokawa P, Lanigan A, Nease DE Jr, Nederveld A, Phimphasone-Brady P, Ritchie ND, Sajatovic M, Wearner R, Begum A, Carter M, Carrigan T, Clay B, Downey D, Koren R, Trujillo SA, Waxmonsky JA. Comparative Effectiveness of Patient-Driven versus Standardized Diabetes Shared Medical Appointments: A Pragmatic Cluster Randomized Trial. J Gen Intern Med. 2024 Nov;39(15):2970-2979. doi: 10.1007/s11606-024-08868-7. Epub 2024 Jun 28.
- Derived from this study: PubMed 36803773Nederveld A, Phimphasone-Brady P, Gurfinkel D, Waxmonsky JA, Kwan BM, Holtrop JS. Delivering diabetes shared medical appointments in primary care: early and mid-program adaptations and implications for successful implementation. BMC Prim Care. 2023 Feb 17;24(1):52. doi: 10.1186/s12875-023-02006-8.
- Derived from this study: PubMed 35906602Holtrop JS, Gurfinkel D, Nederveld A, Phimphasone-Brady P, Hosokawa P, Rubinson C, Waxmonsky JA, Kwan BM. Methods for capturing and analyzing adaptations: implications for implementation research. Implement Sci. 2022 Jul 29;17(1):51. doi: 10.1186/s13012-022-01218-3.
- Derived from this study: PubMed 34598702Glasgow RE, Gurfinkel D, Waxmonsky J, Rementer J, Ritchie ND, Dailey-Vail J, Hosokawa P, Dickinson LM, Kwan BM. Protocol refinement for a diabetes pragmatic trial using the PRECIS-2 framework. BMC Health Serv Res. 2021 Oct 2;21(1):1039. doi: 10.1186/s12913-021-07084-x.
- Derived from this study: PubMed 33677530Dickinson LM, Hosokawa P, Waxmonsky JA, Kwan BM. The problem of imbalance in cluster randomized trials and the benefits of covariate constrained randomization. Fam Pract. 2021 Jun 17;38(3):368-371. doi: 10.1093/fampra/cmab007. No abstract available.
- Derived from this study: PubMed 31924249Kwan BM, Dickinson LM, Glasgow RE, Sajatovic M, Gritz M, Holtrop JS, Nease DE Jr, Ritchie N, Nederveld A, Gurfinkel D, Waxmonsky JA. The Invested in Diabetes Study Protocol: a cluster randomized pragmatic trial comparing standardized and patient-driven diabetes shared medical appointments. Trials. 2020 Jan 10;21(1):65. doi: 10.1186/s13063-019-3938-7.
- Individual participant dataSharing planned: No. The Investigators will be sharing results in aggregate form via publications and reports to the funder.
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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.
Bethany Kwan, PHD, MSPH principal investigator
University of Colorado, Denver
Jeanette Waxmonsky, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized SMA and Patient-driven SMA in people with Diabetes Mellitus, Type 2, run by University of Colorado, Denver 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 11 inclusion and 4 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 Apr 2025. 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?
Yes. Results are posted in the registry (first posted 6 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 - Change in Patient Reported Outcomes (PROs) (time frame: At end of 6 group visits (time differs by practice, up to 6 months)). 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 NCT03590041, which also lists 7 linked publications.
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 Apr 2025.