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Embedded Primary Care MultiDisciplinary Diabetes Clinic

Embedding and Evaluating Multidisciplinary Diabetes Management and Continuous Glucose Monitoring Into Primary Care for a Vulnerable Population

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06015685
Enrollment
185
Registered
2023-08-29
Start date
2023-10-20
Completion date
2025-01-24
Last updated
2026-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Keywords

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

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).

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.

Interventions

OTHEREmbedded 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 continuous glucose monitoring (CGM), a behavioral health provider, and a social worker to assist in finding resources for housing, food, and patient assistance programs.

Sponsors

Emory University
Lead SponsorOTHER
Georgia Center for Diabetes Translation Research
CollaboratorOTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
American Diabetes Association
CollaboratorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Number of Embedded Clinic Patients With an HbA1c >9%Baseline and 6 monthsParticipants with HbA1c \>9% since the embedded clinic implementation. Data will be assessed from electronic medical records (EMR)
HbA1CBaseline and 6 monthsHbA1C results from electronic medical records.

Secondary

MeasureTime frameDescription
Diabetes Self-efficacy ScoreBaseline, 3 months, and 6 monthsParticipants will complete the Diabetes Management Self-Efficacy Scale (DMSES). It assesses the extent to which respondents are confident in their ability to manage their blood sugar, diet, and exercise level. Responses are rated on a 5-point scale ranging from ''can't do at all'' (1) to ''certain can do'' (5). A sum of scores is calculated. On this scale, higher scores in each domain indicate greater self-efficacy in performing Diabetes self-management (DSM) activities, while lower scores indicate specific areas needing educational intervention. Score ranges: Domain 1 Nutrition: 9-45 Domain 2 Treatment: 3-15 Domain 3 Physical Activity: 4-20 Domain 4 Monitoring: 4-20 Overall higher scores indicate a greater self-efficacy (better outcome).
Patient Health Questionnaire (PHQ9)Baseline, 3 months, and 6 monthsDepression will be assessed using the 9-question Patient Health Questionnaire (PHQ9), which 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.
Generalized Anxiety Disorder 7 (GAD-7) ScoreBaseline, 3 months, and 6 monthsGeneralized Anxiety Disorder 7 (GAD-7) is a self-reported questionnaire for screening and severity measuring of generalized anxiety disorder. Questions reflect on symptoms over the past two weeks. Scoring: Items are rated on a scale from 0 ("not at all") to 3 ("nearly every day"), with total scores ranging from 0 to 21. Scores represent 0-4: Minimal Anxiety; 5-9: Mild Anxiety; 10-14: Moderate Anxiety; a score greater than 15: Severe Anxiety

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORBritt A Marshall, MD

Emory University

Participant flow

Recruitment details

The study included a patient intervention and a resident educational curriculum; however, only patients with diabetes were enrolled and included in the clinical trial results reported in this record. Participants were recruited from the Emory Primary Care Clinic at Midtown in Atlanta, Georgia, USA. Participant enrollment began on October 20, 2023, and all follow-up was completed by January 24, 2025.

Pre-assignment details

Residents participated in a 12-month educational curriculum as part of their routine training. They were not consented, no participant-level data were collected, and they were not formally enrolled as study participants. Therefore, they do not constitute an Arm/Group for results reporting. All reported Participant Flow and outcomes (e.g., HbA1c, diabetes management self-efficacy scores) apply only to enrolled participants (patients) with diabetes.

Baseline characteristics

Characteristic
Age, Continuous58 years
STANDARD_DEVIATION 12.3
Diabetes Medication
GLP-1 + SGLT2
38 Participants
Diabetes Medication
Glucagon-like peptide-1 (GLP-1)
27 Participants
Diabetes Medication
Sodium-Glucose Co-Transporter 2 inhibitor (SGLT2)
64 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
0 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
185 Participants
Race (NIH/OMB)
White
0 Participants
Region of Enrollment
United States
185 participants
Sex: Female, Male
Female
100 Participants
Sex: Female, Male
Male
85 Participants
Type of health coverage
Medicaid
28 Participants
Type of health coverage
Medicare
86 Participants
Type of health coverage
Private
59 Participants
Type of health coverage
Uninsured
12 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 141
other
Total, other adverse events
0 / 141
serious
Total, serious adverse events
0 / 141

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 20, 2026