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Diabetes Mellitus, Type 2NCT06015685

Embedded Primary Care MultiDisciplinary Diabetes Clinic

A study testing Embedded Clinic in people with Diabetes Mellitus, Type 2, run by Emory University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to improve diabetes management for patients at Midtown General Internal Medicine Clinic (Aim 1). The clinic offers dedicated diabetes care on certain days with trained providers able to offer dedicated diabetes care. 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?
Embedded Clinic
Could I receive a placebo?
No, everyone receives an active treatment
How many people
185 participants
Where
1 siteUnited States
Study dates
20 Oct 2023to 24 Jan 2025
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

  • Age 18+
  • Patient at Midtown Diabetes Clinic
  • Able to consent
  • HbA1c >=9%
  • All residents in Midtown Primary Care are eligible

Who cannot join

  • Not planning to follow up at Midtown
  • Pregnancy
  • Followed by Endocrinology as a specialist
  • Aim 2 (Embedded diabetes clinic and curriculum):

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Emory Primary Clinic Care at Midtown

    Atlanta, Georgia, 30308

Other trials in United States

About this study

Official title: Embedding and Evaluating Multidisciplinary Diabetes Management and Continuous Glucose Monitoring Into Primary Care for a Vulnerable Population

The purpose of this study is to improve diabetes management for patients at Midtown General Internal Medicine Clinic (Aim 1). The clinic offers dedicated diabetes care on certain days with trained providers able to offer dedicated diabetes care. The clinic will also make sure to address other aspects of life and health that may impact an individual's ability to manage their diabetes - food insecurity, housing insecurity, knowing about healthy food, finding ways to exercise, and mental health. The study will also train the medical residents to be able to participate in this dedicated diabetes care (Aim 2).

Read the detailed description

There is a widening quality of care gap in diabetes mellitus (DM) management that sees Black and Hispanic patients with much higher rates of DM complications and hospitalizations compared to their white counterparts. Primary Care is the frontline for DM prevention and management; however, Primary Care Clinics, including Internal Medicine resident continuity clinics, struggle to improve DM metrics. The lack of resources, such as time and personnel, is a significant limiting factor in strategies that would allow these clinics to optimize care. As a result, the current DM management model was created, in which Primary Care providers refer patients with elevated hemoglobin A1c (HbA1c) to subspecialty care. This process is inefficient, overwhelms subspecialty practices, and most importantly does not address the social determinants of health that often make it difficult for patients to get their DM under control.

This traditional model also comes with a potential institutional financial cost. There is a perception that reducing upfront costs of care can make a system more economically viable; yet this can have devastating results for a system and for its patients on the back end. For example, HbA1c is a Merit-based Incentive Payment System Clinical Quality Measure if a patient population is not supported in their efforts for DM control, this can translate to monetary loss annually for the Emory Healthcare System. In addition, there are also potential losses to the system related to long-term morbidity and mortality risks of elevated HbA1c over time.

Studies have shown that a multi-disciplinary approach including physician, dietitian, DM education, psychotherapy, and social work services functioning concurrently and cooperatively has the potential to positively change the current paradigm. Given the vital role Primary Care plays in the management of all aspects of patient care, including physical and psychosocial well-being, this care delivery model is optimally designed to have the most impact and success in the Primary Care Clinic setting. The research team proposes to embed a multi-disciplinary diabetes-focused clinic within Primary Care in the Emory Healthcare System where this approach would create a central location for all the patients' DM needs, provide efficient care that helps patients address social and economic barriers, and engage the care team through between-clinic touchpoints to motivate patients to take agency over their health. This also provides a venue to implement modern technologies for DM management, such as continuous glucose monitoring (CGM). Despite its proven efficacy in DM management, CGM remains an understudied intervention in Primary Care, especially in patient populations that would otherwise have difficulty accessing specialty care. Researchers anticipate that these changes will enable improved adherence to follow-up visits and treatment.

In addition to the benefits of streamlined patient care, this model also offers the opportunity to enhance Internal Medicine residency education. Investigators intend to develop a hybrid clinical/educational curriculum for residents that capitalizes on and models appropriate resource utilization through an integrated care model and provides early exposure to multi-disciplinary care and CGM.

Being tested
Embedded Clinic
Keywords
Primary Care, Continuous Glucose Monitoring (CGM), Diabetes Management, Multidisciplinary care
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.

  • Embedded ClinicOther

    Also called Multi-disciplinary, team-based DM care

    Once a week, a Primary Care clinic half-day will be dedicated to multi-disciplinary, team-based DM care. The inter-professional team will include an Internal Medicine attending physician, an Internal Medicine resident, a DM educator, a nurse trained in professional continuous glucose monitoring (CGM), a behavioral health provider, and a social worker to assist in finding resources for housing, food, and patient assistance programs.

Study groups in NCT06015685
Study groupRoleWhat they receive
Embedded clinic at MidtownExperimentalUsing the Emory Clinical Data Warehouse (CDW), all patients of Emory Primary Care Midtown with HbA1c >9% who are not currently under the care of an endocrinologist or the diabetes management program at Emory will be invited to participate in this embedded DM management clinic.
Receives: Other: Embedded Clinic

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Embedded Clinic Patients With an HbA1c >9%

    Participants with HbA1c >9% since the embedded clinic implementation. Data will be assessed from electronic medical records (EMR)

    Measured: Baseline and 6 months

  2. HbA1C

    HbA1C results from electronic medical records.

    Measured: Baseline and 6 months

Secondary outcomes (3)
  1. Diabetes Self-efficacy Score

    Participants will complete the Diabetes Management Self-Efficacy Scale (DMSES).

    It assesses the extent to which respondents are confident in their ability to manage their blood sugar, diet, and exercise level. Responses are rated on a 5-point scale ranging from ''can't do at all'' (1) to ''certain can do'' (5). A sum of scores is calculated. On this scale, higher scores in each domain indicate greater self-efficacy in performing Diabetes self-management (DSM) activities, while lower scores indicate specific areas needing educational intervention. Score ranges:

    Domain 1 Nutrition: 9-45 Domain 2 Treatment: 3-15 Domain 3 Physical Activity: 4-20 Domain 4 Monitoring: 4-20

    Overall higher scores indicate a greater self-efficacy (better outcome).

    Measured: Baseline, 3 months, and 6 months

  2. Patient Health Questionnaire (PHQ9)

    Depression will be assessed using the 9-question Patient Health Questionnaire (PHQ9), which is a diagnostic tool to screen adult patients in a primary care setting for the presence and severity of depression. Scores represent: 0-5 = mild 6-10 = moderate 11-15 = moderately severe. 16-20 = severe depression.

    Measured: Baseline, 3 months, and 6 months

  3. Generalized Anxiety Disorder 7 (GAD-7) Score

    Generalized Anxiety Disorder 7 (GAD-7) is a self-reported questionnaire for screening and severity measuring of generalized anxiety disorder. Questions reflect on symptoms over the past two weeks. Scoring: Items are rated on a scale from 0 ("not at all") to 3 ("nearly every day"), with total scores ranging from 0 to 21. Scores represent 0-4: Minimal Anxiety; 5-9: Mild Anxiety; 10-14: Moderate Anxiety; a score greater than 15: Severe Anxiety

    Measured: Baseline, 3 months, and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2023
  2. Study start20 Oct 2023
  3. Primary completion24 Jan 2025
  4. Study completion24 Jan 2025

Resources

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
185 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06015685
Sponsor's protocol ID
STUDY00006033
Other IDs
P30DK111024, 2023P006207
Status last verified
Jul 2026
First submitted
22 Aug 2023
Last updated
19 Aug 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The research team will share deidentified individual participant's data that underlie the results reported in the article after deidentification (text, tables, figures, and appendices)

Questions about this trial

What is this clinical trial studying?

A study testing Embedded Clinic in people with Diabetes Mellitus, Type 2, run by Emory University 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 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 19 Aug 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?

Yes. Results are posted in the registry (first posted 19 Aug 2026). 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?

Number of Embedded Clinic Patients With an HbA1c >9% (time frame: Baseline and 6 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 19 Aug 2026.

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Clinical Trial NCT06015685 | AzTrials