Embedded Multidisciplinary Diabetes Clinic for Diabetes

Overseen By Britt A Marshall, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: Pregnancy, Endocrinology follow-up, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve diabetes care for patients at a specific clinic by offering dedicated support and addressing life factors such as food and housing. It will also provide special training for doctors in training to deliver this care. The trial will compare patients receiving enhanced care at the Embedded Primary Care MultiDisciplinary Diabetes Clinic to those receiving routine care at a different clinic. Patients with diabetes and an HbA1c level over 9% (a measure of blood sugar control) who are not seeing a diabetes specialist might be a good fit. As an unphased trial, this study offers a unique opportunity to receive comprehensive care and support tailored to individual needs.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this embedded clinic is safe for diabetes management?

Research has shown that clinics with teams of diverse healthcare specialists are generally safe and well-received by people with diabetes. One study demonstrated that a similar clinic setup helped patients improve their blood sugar levels without major safety issues. This method involves a team of healthcare providers collaborating to manage diabetes more effectively.

Studies have not reported significant harmful effects, suggesting that this treatment is safe for most people. These clinics aim to improve overall health by also focusing on related areas like diet, exercise, and mental well-being. This comprehensive care is designed to help people with diabetes without causing harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Embedded Multidisciplinary Diabetes Clinic because it offers a fresh approach by integrating various healthcare specialists directly into primary care settings. Unlike traditional diabetes management, which often involves patients visiting separate specialists, this model allows for a more coordinated and personalized care experience. This integration can lead to more consistent monitoring and tailored treatment plans, potentially improving outcomes for patients with high HbA1c levels who aren't already seeing a diabetes specialist. By embedding these services, the approach aims to streamline healthcare delivery and enhance patient engagement.

What evidence suggests that this embedded clinic is effective for diabetes management?

Research has shown that a diabetes clinic with a team of specialists can greatly improve diabetes management. In this trial, participants in the "Embedded clinic at Midtown" arm will experience this multidisciplinary approach. Studies have found that these clinics help lower HbA1c levels, an important measure of blood sugar control. For instance, one study found that patients adhered better to their medications and faced fewer heart-related health risks. Another study demonstrated that these clinics improve both health outcomes and lifestyle habits, such as eating well and exercising. Over ten years, the success of these clinics has been proven using a chronic care model, which focuses on comprehensive disease management. This approach helps patients manage not only their diabetes but also related issues like access to food and housing. ^{1 6 7 8 9}

Who Is on the Research Team?

Britt A Marshall, MD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for adults over 18 with poorly controlled Type 2 Diabetes (HbA1c >=9%) who are patients at Midtown Diabetes Clinic and can consent to participate. It's not for pregnant individuals, those not planning to continue care at Midtown, or anyone already seeing a specialist in endocrinology.

Inclusion Criteria

All residents in Midtown Primary Care are eligible

Your HbA1c level is 9% or higher.

Patient at Midtown Diabetes Clinic

Exclusion Criteria

Not planning to follow up at Midtown

You have been seeing an endocrinologist for specialized care.

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive multidisciplinary diabetes management and continuous glucose monitoring

6 months

Regular visits as per clinic schedule

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Follow-up visits at 3 and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Embedded Primary Care MultiDisciplinary Diabetes Clinic

Trial Overview The study tests an 'Embedded Clinic' model versus routine care. The clinic provides specialized diabetes management on certain days, addressing factors like food and housing security, diet education, exercise opportunities, and mental health alongside training medical residents.

How Is the Trial Designed?

Group I: Routine Care- Dunwoody Family Medicine Clinic Experimental Treatment 1 Intervention

The control population will be drawn using electronic health record data of diabetes patients at Dunwoody Family Medicine Clinic. Information from the Electronic Health Record will be de-identified after extraction. Control participants will be frequency matched.

Group II: Embedded clinic at Midtown Experimental Treatment 1 Intervention

Using 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.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

Georgia Center for Diabetes Translation Research

Collaborator

Trials

5

Recruited

200+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

American Diabetes Association

Collaborator

Trials

148

Recruited

102,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34088818/

A Multidisciplinary Diabetes Clinic Improves Clinical and ... The study objective was to evaluate effects of a multidisciplinary approach on behavioral outcomes and mean change in A1c in immediate start (intervention) ...

2. jabfm.org jabfm.org/content/34/3/579/tab-figures-data

A Multidisciplinary Diabetes Clinic Improves Clinical and ... A Multidisciplinary Diabetes Clinic Improves Clinical and Behavioral Outcomes in a Primary Care Setting · Article · Figures & Data · References · Info & ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10804690/

An Effectiveness Study of a Primary Care-embedded ... Consequently, the medication adherence rate for patients with diabetes and Medicaid coverage has been found to range anywhere from 36% to 67%. Using Behavioral ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1751991824001116

The effects of multidisciplinary collaborative care on ... Multidisciplinary collaborative care is associated with reduced cardiovascular risk factors among patients with diabetes in primary care.

5. diabetesjournals.org diabetesjournals.org/care/article/45/12/2871/147443/Ten-Year-Effectiveness-of-the-Multidisciplinary

Ten-Year Effectiveness of the Multidisciplinary Risk ... Multiple randomized clinical trials have demonstrated the effectiveness of disease management programs that used the chronic care model with ...

6. jabfm.org jabfm.org/content/jabfp/34/3/579.full.pdf

A Multidisciplinary Diabetes Clinic Improves ... For the delayed intervention group, mean A1c values decreased from 10.2 at baseline to 9.0 after 6 months. Conclusions: Use of a ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6720083/

Effect of multidisciplinary intensive targeted care in improving ... Intensive diabetes mellitus care with patient empowerment may lead to sustained glycemic control, reduction of clinical complications and progression of ...

8. diabetesjournals.org diabetesjournals.org/care/article/46/10/1750/153612/Pragmatic-Evidence-for-Theory-Based-Innovations-in

Pragmatic Evidence for Theory-Based Innovations in Diabetes ... The next step to improving diabetes care in PC is building an evidence base of real-world examples with use of specific PC management processes ...

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1751991819301779

Impact of diabetes education teams in primary care on ... Onsite education teams in primary care settings can potentially improve diabetes management as shown in two process of care indicators: medical visits and foot ...