Diabetes Mellitus, Type 2NCT06643611
Addressing Disparities in Diabetes Care
A study testing Continuous Glucose Monitor in people with Diabetes Mellitus, Type 2, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The purpose of this research is to find out if using a continuous glucose monitor and working with a clinical pharmacist can help improve the health of uninsured minority patients with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Continuous Glucose Monitor
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2024to 22 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hispanic or non-Hispanic Black
- Diagnosis of Type 2 diabetes
- HbA1c ≥8% within the past 3 months
- Active prescription for insulin and injecting at least 1 time daily
Who cannot join
- Gestational diabetes
- Type 1 diabetes
- Receiving care by endocrinologist
- Continuous glucose monitor use within the past 6 months
- Receiving long term, hospice, or palliative care services
- Malignant cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
Atrium Health Myers Park Internal Medicine Clinic
Charlotte, North Carolina, 28207
About this study
Official title: Addressing Disparities in Diabetes Care: Integrating Continuous Glucose Monitors and Pharmacist Medication Management for Uninsured Racial Minority Patients
The purpose of this research is to find out if using a continuous glucose monitor and working with a clinical pharmacist can help improve the health of uninsured minority patients with type 2 diabetes.
Read the detailed description
The objective of this research is to determine the effectiveness of a targeted intervention that integrates continuous glucose monitors and pharmacist-led comprehensive medication management services among uninsured adult patients with poor glycemic control on basal insulin, specifically focusing on Black and Hispanic populations. This pilot study is designed to help justify implementing this intervention on a larger scale within our healthcare system.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Continuous Glucose Monitor, Usual Care
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Glucose MonitorBehavioural
Patient will be provided a continuous glucose monitor. Pharmacist will provide information regarding how to best manage type 2 diabetes.
Usual CareBehavioural
Routine physician office visits and hemoglobinA1c every 3 for those with HbA1c outside goal and every 6 months for those with HbA1c within goal. Medication regimens managed by physicians, nurse practitioners, and physician assistants. Patients are sent reminders on the phone prior to their visits or when they are due for a visit or any physical examination.
| Study group | Role | What they receive |
|---|---|---|
| Continuous Glucose Monitor | Experimental | Patients in the intervention arm will receive a continuous glucose monitor in addition to usual care. These patients will be scheduled at least once monthly for clinical pharmacy visits. Receives: Behavioral: Continuous Glucose Monitor |
| Usual Care | Active comparator | Patients in the usual care arm will have routine physician office visits every 3 months if HbA1c outside goal or every 6 months if HbA1c within goal. Medication regimens will be managed by physicians, nurse practitioners, and physician assistants. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hemoglobin A1c
Change in percentage for Hemoglobin A1c. Normal range for hemoglobin A1c is 4.2%-14%. A low level indicates no diabetes and a high level indicates uncontrolled diabetes.
Measured: Baseline to Month 6
Secondary outcomes (8)
Appraisal of Diabetes Scale
Health-related quality of life will be measured using Appraisal of Diabetes scale (ADS). The ADS is a diabetes-specific quality of life instrument. It consists of 7 items on how diabetes affects the respondent. The score of each item ranges from 0 to 5 with 0 representing the least effect of diabetes and 5 the greatest effect of diabetes. The total score is calculated by summing the scores of individual items.
Measured: Baseline, 1 Month Post Intervention
Diabetes Treatment Satisfaction Questionnaire
Treatment satisfaction will be measured using the Diabetes Treatment Satisfaction Questionnaire (DTSQ). The DTSQ includes eight items on satisfaction with diabetes treatment, convenience, flexibility, understanding of diabetes, possibility of continuation of the current treatment and recommendation to others. Each item is scored on a scale from 0 to 6, with higher score indicating higher satisfaction.
Measured: Baseline, 1 Month Post Intervention
Change in Medication Adherence
Medication adherence will be determined from prescription fill data and reported in the form of medication possession ratio (the sum of days of supply during a time period divided by the number of days in that time period). The change during six months before and after intervention start (time of assessment of study criteria for the control group) will be reported.
Measured: 6 Months Post Intervention
Number of Hours Glucose Level in Normal Range
Number of hours patient's glucose level is within normal range of 70-100.
Measured: Week 1 and 2 of intervention, Last Two Weeks of Intervention
Number of Hours Glucose Level Above Normal Range
Number of hours patient's glucose level is above normal range of 70-100.
Measured: Week 1 and 2 of intervention, Last Two Weeks of Intervention
Number of Hours Glucose Level Below Normal Range
Number of hours patient's glucose level is below normal range of 70-100.
Measured: Week 1 and 2 of intervention, Last Two Weeks of Intervention
Average Glucose Level
Average glucose level during the first two weeks of intervention. Normal range is 70-100 mg/dL. A low-level average indicates good glycemic control. A high level indicates uncontrolled diabetes.
Measured: Week 1 and 2 of intervention, Last Two Weeks of Intervention
Glucose Management Indicator Percentage
The glucose management indicator is an updated approach for estimating hemoglobin A1c from continuous glucose monitoring data. Range is 5.7%-14%.
Measured: Week 1 and 2 of intervention, Last Two Weeks of Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start18 Nov 2024
- Primary completion12 Aug 2025
- Study completion22 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- American Society of Health-System Pharmacists
- Responsible party
- Sponsor
- Investigators
- Ryan Larson, PharmD, CPP, Principal investigator, Myers Park Internal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06643611
- Sponsor's protocol ID
- IRB00115753
- Status last verified
- Sep 2025
- First submitted
- 10 Oct 2024
- Last updated
- 3 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Disparities in Diabetes Care: Integrating Continuous Glucose Monitors and Pharmacist Medication Management for Uninsured Racial Minority Patients
- ClinicalTrials.gov ID
- NCT06643611
- Acronym / sponsor ID
- IRB00115753
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- American Society of Health-System Pharmacists
- Study start
- 18 Nov 2024 (actual)
- Primary completion
- 12 Aug 2025 (actual)
- Study completion
- 22 Sep 2025 (actual)
- First posted
- 16 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to find out if using a continuous glucose monitor and working with a clinical pharmacist can help improve the health of uninsured minority patients with type 2 diabetes.
Detailed description
The objective of this research is to determine the effectiveness of a targeted intervention that integrates continuous glucose monitors and pharmacist-led comprehensive medication management services among uninsured adult patients with poor glycemic control on basal insulin, specifically focusing on Black and Hispanic populations. This pilot study is designed to help justify implementing this intervention on a larger scale within our healthcare system.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous Glucose Monitor | Experimental | Behavioral: Continuous Glucose MonitorPatients in the intervention arm will receive a continuous glucose monitor in addition to usual care. These patients will be scheduled at least once monthly for clinical pharmacy visits. |
| Usual Care | Active comparator | Behavioral: Usual CarePatients in the usual care arm will have routine physician office visits every 3 months if HbA1c outside goal or every 6 months if HbA1c within goal. Medication regimens will be managed by physicians, nurse practitioners, and physician assistants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Hispanic or non-Hispanic Black
- Diagnosis of Type 2 diabetes
- HbA1c ≥8% within the past 3 months
- Active prescription for insulin and injecting at least 1 time daily
Key exclusion criteria (6 listed)
- Gestational diabetes
- Type 1 diabetes
- Receiving care by endocrinologist
- Continuous glucose monitor use within the past 6 months
- Receiving long term, hospice, or palliative care services
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous Glucose MonitorPatient will be provided a continuous glucose monitor. Pharmacist will provide information regarding how to best manage type 2 diabetes. | Behavioural | Continuous Glucose Monitor |
| Usual CareRoutine physician office visits and hemoglobinA1c every 3 for those with HbA1c outside goal and every 6 months for those with HbA1c within goal. Medication regimens managed by physicians, nurse practitioners, and physician assistants. Patients are sent reminders on the phone prior to their visits or when they are due for a visit or any physical examination. | Behavioural | Usual Care |
Primary outcome
Change in Hemoglobin A1c
Time frame: Baseline to Month 6
Change in percentage for Hemoglobin A1c. Normal range for hemoglobin A1c is 4.2%-14%. A low level indicates no diabetes and a high level indicates uncontrolled diabetes.
8 secondary outcomes
Appraisal of Diabetes Scale
Time frame: Baseline, 1 Month Post Intervention
Diabetes Treatment Satisfaction Questionnaire
Time frame: Baseline, 1 Month Post Intervention
Change in Medication Adherence
Time frame: 6 Months Post Intervention
Number of Hours Glucose Level in Normal Range
Time frame: Week 1 and 2 of intervention, Last Two Weeks of Intervention
Number of Hours Glucose Level Above Normal Range
Time frame: Week 1 and 2 of intervention, Last Two Weeks of Intervention
Number of Hours Glucose Level Below Normal Range
Time frame: Week 1 and 2 of intervention, Last Two Weeks of Intervention
Average Glucose Level
Time frame: Week 1 and 2 of intervention, Last Two Weeks of Intervention
Glucose Management Indicator Percentage
Time frame: Week 1 and 2 of intervention, Last Two Weeks of Intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryan Larson, PharmD, CPP principal investigator
Myers Park Internal Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Glucose Monitor in people with Diabetes Mellitus, Type 2, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hemoglobin A1c (time frame: Baseline to Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2025.