Embedded Primary Care MultiDisciplinary Diabetes Clinic

NCT06015685 | Completed DMC

• 3 other identifiers: STUDY00006033P30DK1110242023P006207
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Diabetes Mellitus, Type 2

Keywords

Primary Care; Continuous Glucose Monitoring (CGM); Diabetes Management; Multidisciplinary care

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• Change in weight

  Baseline, 3 months, and 6 months

• Change in body mass index (BMI)

  Baseline, 3 months, and 6 months

• Change in diabetes self-efficacy score

  Baseline, 3 months, and 6 months

• Change in depression status

  Baseline, 3 months, and 6 months

• Change in the patient-reported quality of life score

  Baseline, 3 months, and 6 months

Study Arms (2)

Embedded clinic at Midtown

EXPERIMENTAL

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

Routine Care- Dunwoody Family Medicine Clinic

OTHER

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

Interventions

Embedded Clinic OTHER

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.

Also known as: multi-disciplinary, team-based DM care

Embedded clinic at Midtown

Routine Care OTHER

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.

Also known as: Control Group

Routine Care- Dunwoody Family Medicine Clinic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Not planning to follow up at Midtown
• Pregnancy
• Followed by Endocrinology as a specialist
• Aim 2 (Embedded diabetes clinic and curriculum):
• \- All residents in Midtown Primary Care are eligible

Sponsors & Collaborators

• Emory University: lead
• American Diabetes Association: collaborator
• Georgia Center for Diabetes Translation Research: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Emory Primary Clinic Care at Midtown

Atlanta, Georgia, 30308, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Britt A Marshall, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 22, 2023
• First Posted: August 29, 2023
• Study Start: October 20, 2023
• Primary Completion: January 24, 2025
• Study Completion: January 24, 2025
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The research team will share the deidentified data immediately following publication, with no known end date.
• 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.

Locations

US (1)