Diabetes Mellitus, Type 2
Conditions
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
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
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Number of Embedded Clinic Patients With an HbA1c >9% | Baseline and 6 months | Participants with HbA1c \>9% since the embedded clinic implementation. Data will be assessed from electronic medical records (EMR) |
| HbA1C | Baseline and 6 months | HbA1C results from electronic medical records. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diabetes Self-efficacy Score | Baseline, 3 months, and 6 months | Participants 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 months | Depression 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) Score | Baseline, 3 months, and 6 months | Generalized 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
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, Continuous | 58 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 type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 141 |
| other Total, other adverse events | 0 / 141 |
| serious Total, serious adverse events | 0 / 141 |