Embedded Primary Care MultiDisciplinary Diabetes Clinic

NCT06015685 | Completed Results DMC

• 3 other identifiers: STUDY00006033P30DK1110242023P006207
• Study Type: interventional
• Target: 185
• 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 (2)

• 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)

  Baseline and 6 months

• HbA1C

  HbA1C results from electronic medical records.

  Baseline and 6 months

Secondary Outcomes (3)

• Diabetes Self-efficacy Score

  Baseline, 3 months, and 6 months

• Patient Health Questionnaire (PHQ9)

  Baseline, 3 months, and 6 months

• Generalized Anxiety Disorder 7 (GAD-7) Score

  Baseline, 3 months, and 6 months

Other Outcomes (3)

• Latin American and Caribbean (ELSCA) Household Food Security Measurement Scale

  Baseline, 3 months, and 6 months

• Urine Microalbumin

  Baseline, 3 months, and 6 months

• Housing Insecurity Instrument

  Baseline, 3 months, and 6 months

Study Arms (1)

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

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 continuous glucose monitoring (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

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
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Georgia Center for Diabetes Translation Research: collaborator

Study Sites (1)

Emory Primary Clinic Care at Midtown

Atlanta, Georgia, 30308, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Britt A. Marshall
• Organization: Emory University

britt.marshall@emory.edu

(404) 686-4411

Study Officials

• Britt A Marshall, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• 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: August 19, 2026
• Results First Posted: August 19, 2026

Record last verified: 2026-07

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)