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

65 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

Research Team

Britt A Marshall, MD

Principal Investigator

Emory University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+