Embedded Primary Care MultiDisciplinary Diabetes Clinic

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).

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Other: Routine Care; Other: Embedded Clinic

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.

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Emory Primary Clinic Care at Midtown

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Aim 1 (Embedded diabetes clinic):

Inclusion Criteria:

• Age 18+
• Patient at Midtown Diabetes Clinic
• Able to consent
• HbA1c >=9%

Exclusion Criteria:

• Not planning to follow up at Midtown
• Pregnancy
• Followed by Endocrinology as a specialist

Aim 2 (Embedded diabetes clinic and curriculum):

Inclusion Criteria:

- All residents in Midtown Primary Care are eligible

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Embedded clinic at Midtown; 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.	Other: Embedded Clinic; 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 CGM, a behavioral health provider, and a social worker to assist in finding resources for housing, food, and patient assistance programs.; Other Names: multi-disciplinary, team-based DM care
Other: Routine Care- Dunwoody Family Medicine Clinic; 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.	Other: Routine Care; Researchers will use a 2:1 ratio of control to intervention patients. Using the CDW, researchers will identify a control population [patients who receive routine care (i.e., referral to subspecialty care)], who will be a propensity-matched cohort of individuals with similar age, gender, race/ethnicity, zip codes, insurance type, visit dates, and co-morbidities (Charlson Comorbidity Index) as the intervention group.; Other Names: Control Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the proportion of embedded clinic patients with an HbA1c >9%	Percentage of participants with HbA1c >9% since the embedded clinic implementation. Data will be assessed from electronic medical records (EMR)	Baseline and 6 months
Change in acceptability of intervention measure (AIM)	AIM score is a four-item measures of implementation outcomes that are often considered "leading indicators" of implementation success (likert scale 1-5 with 5 being best outcome) at the baseline and 6-month follow-up visits will be used by the team members to assess the acceptability of model implementation.	Baseline and 6 months
Change in feasibility of intervention measure (FIM) scores	FIM score is a four-item measures of implementation outcomes that are often considered "leading indicators" of implementation success likert scale 1-5 with 5 being best outcome) at the baseline and 6-month follow-up visits will be used by the team members to assess the feasibility of model implementation.	Baseline and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in weight	Change in weight will be assessed from available measurements in EMR.	Baseline, 3 months, and 6 months
Change in body mass index (BMI)	BMI will be calculated from available measurements in EMR	Baseline, 3 months, and 6 months
Change in diabetes self-efficacy score	Participants will complete the diabetes management self-efficacy scale (DMSES). It assesses the extent to which respondents are confident they can manage their blood sugar, diet, and level of exercise. Responses are rated on a 5-point scale ranging from ''can't do at all'' to ''certain can do'' (1, 5). In this scale, higher scores indicate higher self-efficacy in performing Diabetes self-management (DSM) activities.	Baseline, 3 months, and 6 months
Change in depression status	The 9-question Patient Health Questionnaire (PHQ9) 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.	Baseline, 3 months, and 6 months
Change in the patient-reported quality of life score	Participants will complete the Patient-Reported Outcomes Measurement Information System (PROMIS) survey. The possible score ranges from 0 to 20 points in each case. 0 points represent the patient's most severe physical and/or mental impairment, while 20 points represent the best possible state of health.	Baseline, 3 months, and 6 months
Change in anxiety score	Generalized Anxiety Disorder 7 (GAD-7) is a self-reported questionnaire for screening and severity measuring of generalized anxiety disorder. Scores represent 0-4: Minimal Anxiety; 5-9: Mild Anxiety; 10-14: Moderate Anxiety; a score greater than 15: Severe Anxiety	Baseline, 3 months, and 6 months
Change in food insecurity	Participants will complete the Latin American and Caribbean (ELSCA) Household Food Security Measurement Scale. This scale uses a set of 15 questions, with yes/no response categories, seven of which are for households with children. Each question asks the respondent whether he/she or any other household member has experienced a certain manifestation of food insecurity in the previous three months. Households that affirm 3 items are classified as food insecure.	Baseline, 3 months, and 6 months
Change in Housing Insecurity	Percentage of participants of being at risk for housing insecurity by answering the 2-question housing insecurity instrument: (1) "Are you worried or concerned that in the next 2 months you may not have stable housing that you own, rent, or stay in as part of a household?" with responses of "yes" or "no," and (2) "How likely do you think it would be that you would have to use a homeless shelter in the next 6 months?" with 4 response options ranging from "very unlikely" to "very likely."	Baseline, 3 months, and 6 months
Change in urine microalbumin	Change in urine microalbumin (mcg/mg min 0 and higher the worse the outcome) will be calculated from available laboratory assessments from EMR	Baseline, 3 months, and 6 months

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); American Diabetes Association; Georgia Center for Diabetes Translation Research
• Investigators: Principal Investigator: Britt A Marshall, MD, Emory University

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2023
• Primary Completion (Actual): January 24, 2025
• Study Completion (Actual): January 24, 2025

Study Registration Dates

• First Submitted: August 22, 2023
• First Submitted That Met QC Criteria: August 23, 2023
• First Posted (Actual): August 29, 2023

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Diabetes Management; Primary Care; Multidisciplinary care; Continuous Glucose Monitoring (CGM)
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods; Control Groups
• Other Study ID Numbers: STUDY00006033; P30DK111024 (U.S. NIH Grant/Contract); 2023P006207 (Other Identifier: Emory Insight Humans IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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)
• IPD Sharing Time Frame: The research team will share the deidentified data immediately following publication, with no known end date.

IPD Sharing Access Criteria

Data will be shared with researchers who provide a methodologically sound proposal to achieve the aims specified in their proposal

All proposals should be sent to britt.marshall@emory.edu.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes