Trial Outcomes & Findings for Embedded Primary Care MultiDisciplinary Diabetes Clinic (NCT NCT06015685)

NCT ID: NCT06015685

Last Updated: 2026-08-19

Results Overview

Participants with HbA1c \>9% since the embedded clinic implementation. Data will be assessed from electronic medical records (EMR)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

185 participants

Primary outcome timeframe

Baseline and 6 months

Results posted on

2026-08-19

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure
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. 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.
Overall Study
STARTED
185
Overall Study
COMPLETED
141
Overall Study
NOT COMPLETED
44

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Embedded Primary Care MultiDisciplinary Diabetes Clinic

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Embedded Clinic at Midtown
n=185 Participants
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. 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 continuous glucose monitoring (CGM), a behavioral health provider, and a social worker to assist in finding resources for housing, food, and patient assistance programs.
Age, Continuous
58 years
STANDARD_DEVIATION 12.3 • n=298 Participants
Sex: Female, Male
Female
100 Participants
n=298 Participants
Sex: Female, Male
Male
85 Participants
n=298 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=298 Participants
Race (NIH/OMB)
Asian
0 Participants
n=298 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=298 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=298 Participants
Race (NIH/OMB)
White
0 Participants
n=298 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=298 Participants
Race (NIH/OMB)
Unknown or Not Reported
185 Participants
n=298 Participants
Region of Enrollment
United States
185 participants
n=298 Participants
Type of health coverage
Medicaid
28 Participants
n=298 Participants
Type of health coverage
Medicare
86 Participants
n=298 Participants
Type of health coverage
Private
59 Participants
n=298 Participants
Type of health coverage
Uninsured
12 Participants
n=298 Participants
Diabetes Medication
Glucagon-like peptide-1 (GLP-1)
27 Participants
n=298 Participants
Diabetes Medication
Sodium-Glucose Co-Transporter 2 inhibitor (SGLT2)
64 Participants
n=298 Participants
Diabetes Medication
GLP-1 + SGLT2
38 Participants
n=298 Participants

PRIMARY outcome

Timeframe: Baseline and 6 months

Population: Outcome applies to participants with diabetes only. Residents underwent an educational curriculum as part of their routine training, and outcomes do not apply to the medical residents.

Participants with HbA1c \>9% since the embedded clinic implementation. Data will be assessed from electronic medical records (EMR)

Outcome measures

Outcome measures
Measure
Embedded Clinic at Midtown
n=141 Participants
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. 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.
Number of Embedded Clinic Patients With an HbA1c >9%
Baseline
141 Participants
Number of Embedded Clinic Patients With an HbA1c >9%
6 months
64 Participants

PRIMARY outcome

Timeframe: Baseline and 6 months

HbA1C results from electronic medical records.

Outcome measures

Outcome measures
Measure
Embedded Clinic at Midtown
n=141 Participants
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. 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.
HbA1C
Baseline
11.60 % of glycated hemoglobin
Standard Deviation 1.97
HbA1C
6 months
9.60 % of glycated hemoglobin
Standard Deviation 2.43

SECONDARY outcome

Timeframe: Baseline, 3 months, and 6 months

Population: Results include participants who completed the relevant questionnaires and provided valid data at each specified study visit. Participant attrition occurred over the course of the study. By the 6-month follow-up, no participants were willing to complete the final DMSES survey, resulting in zero data entries for this time point.

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).

Outcome measures

Outcome measures
Measure
Embedded Clinic at Midtown
n=32 Participants
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. 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.
Diabetes Self-efficacy Score
Domain 1: Nutrition (Baseline)
27.00 score on a scale
Standard Deviation 10.70
Diabetes Self-efficacy Score
Domain 1: Nutrition (3 months)
28.62 score on a scale
Standard Deviation 9.37
Diabetes Self-efficacy Score
Domain 2: Treatment (Baseline)
12.73 score on a scale
Standard Deviation 3.05
Diabetes Self-efficacy Score
Domain 2: Treatment (3 months)
14.31 score on a scale
Standard Deviation 1.29
Diabetes Self-efficacy Score
Domain 3: Physical Activity (Baseline)
15.54 score on a scale
Standard Deviation 4.13
Diabetes Self-efficacy Score
Domain 3: Physical Activity (3 months)
15.00 score on a scale
Standard Deviation 4.13
Diabetes Self-efficacy Score
Domain 4 - Monitoring (Baseline)
16.77 score on a scale
Standard Deviation 4.03
Diabetes Self-efficacy Score
Domain 4 - Monitoring (3 months)
18.00 score on a scale
Standard Deviation 1.85

SECONDARY outcome

Timeframe: Baseline, 3 months, and 6 months

Population: Results include only participants who completed the corresponding questionnaires at each time-point visit.

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.

Outcome measures

Outcome measures
Measure
Embedded Clinic at Midtown
n=68 Participants
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. 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.
Patient Health Questionnaire (PHQ9)
6 months
4.2 score on a scale
Standard Deviation 2.95
Patient Health Questionnaire (PHQ9)
Baseline
5.67 score on a scale
Standard Deviation 6.08
Patient Health Questionnaire (PHQ9)
3 months
3.82 score on a scale
Standard Deviation 4.08

SECONDARY outcome

Timeframe: Baseline, 3 months, and 6 months

Population: Results include participants who completed the corresponding questionnaires and provided valid data at each specified time point visit.

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

Outcome measures

Outcome measures
Measure
Embedded Clinic at Midtown
n=67 Participants
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. 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.
Generalized Anxiety Disorder 7 (GAD-7) Score
Baseline
4.55 score on a scale
Standard Deviation 5.94
Generalized Anxiety Disorder 7 (GAD-7) Score
3 months
3.61 score on a scale
Standard Deviation 4.69
Generalized Anxiety Disorder 7 (GAD-7) Score
6 months
2 score on a scale
Standard Deviation 2.00

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 3 months, and 6 months

To measure 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 3 months, and 6 months

Change in urine microalbumin (mcg/mg min 0 and higher the worse the outcome) will be calculated from available laboratory assessments from EMR

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 3 months, and 6 months

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."

Outcome measures

Outcome data not reported

Adverse Events

Embedded Clinic at Midtown

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Britt A. Marshall

Emory University

Phone: (404) 686-4411

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place