Diabetes Mellitus, Type 2NCT06517576
Using Remote Monitoring to Address Health Disparities in Type 2 Diabetes
A study testing Blood glucose monitor with Digital Platform and Health Coaching and Continuous glucose monitor in people with Diabetes Mellitus, Type 2, run by Lawndale Christian Health Center at 1 site in United States.
Trial summary
Patient populations at community health centers, specifically Black or African American and Hispanic or Latino populations with Type 2 diabetes, experience significant health disparities. 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?
- Blood glucose monitor with Digital Platform and Health Coaching and Continuous glucose monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2024to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 18 years of age or older
- Have an assigned primary care provider
- Diagnosis of Type 2 diabetes
- Medication use is insulin
- HbA1c of 8.0% or higher
Who cannot join
- Diagnosis of chronic kidney disease at Stage 4 or higher
- Diagnosis of pregnancy
- Diagnosis of behavioral health conditions including serious mental illness or severe depression in the past 6 months.
- All participants must have a smartphone that is able to access internet services.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Lawndale Christian Health Center
Chicago, Illinois, 60623
About this study
Official title: Randomized Controlled Trial Using Remote Monitoring With an Automated Patient Engagement System and a Self-Monitoring Program With Continuous Glucose Monitors to Address Health Disparities in Type 2 Diabetes
Patient populations at community health centers, specifically Black or African American and Hispanic or Latino populations with Type 2 diabetes, experience significant health disparities. In particular, they have higher rates of diabetes-related complications and other related conditions such as myocardial infarction, cerebrovascular disease, kidney failure, blindness, neuropathy, and the risk of amputation. Diabetes affects 34 million adults in the US. Achieving a target HbA1c less than 8% can be challenging through diabetes management. Patients are able to monitor their blood glucose levels with devices such as blood glucose meters or continuous glucose monitors to facilitate diabetes management and glycemic control. Past studies have demonstrated that these devices are effective in engaging patients in the improvement of diabetes management. Current advancements in remote patient monitoring and self-monitoring have been observed to be effective in facilitating improvement in diabetes outcomes. However, the effectiveness and financial feasibility of these devices delivered in conjunction with automated patient engagement systems in remote patient monitoring programs is not well understood among underinsured, underserved, and vulnerable minority populations as they face a high-cost barrier particularly with continuous glucose monitors. To better address this gap in knowledge, this pilot study will compare and examine the effectiveness of these interventions on patient outcomes with Type 2 diabetes among populations in the West Side of Chicago. Study the comparative effectiveness among patients with uncontrolled Type 2 diabetes on insulin in an intervention group using remote patient monitoring and automated patient engagement system with blood glucose monitors to a group using a self-monitoring program with continuous glucose monitors and a usual care group receiving standard care. Conduct a feasibility analysis and financial impact of these programs among an underinsured and underserved population of Black/African Americans or Hispanic/Latinos with Type 2 diabetes.
Read the detailed description
This will be conducted at a Lawndale Christian Health Center, a community health center in the West Side of Chicago that serves a largely Black or African American and Hispanic or Latino population. To accomplish this objective, Aim 1 will study the impact on patients with uncontrolled Type 2 diabetes on insulin by comparing an intervention group that features remote patient monitoring with an automated patient engagement system and health coaching using blood glucose meters compared to a group that features a self-monitoring program using continuous glucose monitoring devices and a usual care group with standard care, and Aim 2 will examine the feasibility of implementing these interventions and financial impact of each treatment group at a community health center. To understand the effect of this study on health outcomes, patient level data will be examined including primary outcomes for health measurements such as HbA1c, blood glucose, BMI/weight, estimated glomerular filtration rate (eGFR), patient-reported outcomes including medication adherence, daily activities, diabetes self-management activities, and secondary outcomes for health measurements such as LDL cholesterol, systolic and diastolic blood pressures, as well as implementation outcomes such as acceptability, appropriateness, and feasibility. The costs of implementation and delivery will be examined using a budget impact analysis. This study will be essential for informing the impact on health disparities through remote monitoring with automated patient engagement compared to self-monitoring when providing care for underinsured and underserved populations.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Blood glucose monitor with Digital Platform and Health Coaching, Continuous glucose monitor, Usual Care
- Keywords
- Type 2 Diabetes, Remote Patient Monitoring
- 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.
Blood glucose monitor with Digital Platform and Health CoachingDevice
Also called Bluetooth Blood Glucose Monitor, 3011065399
Blood glucose monitors will be used daily to measure blood glucose measurements.
Continuous glucose monitorDevice
Also called Dexcom G7 Continuous Glucose Monitoring System, 3004753838
Continuous glucose monitors will be used daily to measure blood glucose measurements.
Usual CareOther
Usual care for type 2 diabetes
| Study group | Role | What they receive |
|---|---|---|
| Remote patient monitoring and automated patient engagement system with blood glucose monitors | Experimental | Participants in this group will receive blood glucose monitors and will check their blood glucose daily with monitoring through a digital platform and provided health coaching. Receives: Device: Blood glucose monitor with Digital Platform and Health Coaching |
| Self-monitoring program with continuous glucose monitors | Experimental | Participants in this group will receive continuous glucose monitors and will self monitor their blood glucose measurements with support by their care team. Receives: Device: Continuous glucose monitor |
| Usual care group receiving standard care | Active comparator | Participants in this group will receive standard care for diabetes. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycated Hemoglobin
HbA1c based on blood sugar attached to hemoglobin based on lab analysis of blood.
Measured: Baseline and at 4 Months
Blood Glucose
Blood glucose measurements based blood glucose monitor (BGM) and continuous glucose monitor (CGMs).
Measured: 4 Months
Engagement with digital platform with a daily submission of blood glucose
Daily blood glucose measurements from blood glucose monitor submitted to the digital platform
Measured: 4 Months
Implementation - Acceptability of Intervention Measure (AIM)
Self-reported perception among patients that this service is agreeable, palatable, or satisfactory with a likert scale of disagree to agree.
Measured: Baseline and at 4 Months
Implementation - Intervention Appropriateness Measure (IAM)
Self-reported perception among patients that this service is fit, relevant, and compatible with a likert scale of disagree to agree.
Measured: Baseline and at 4 Months
Implementation - Feasibility of Intervention Measure (FIM)
Self-reported perception among patients that this service is successfully used or carried out within a primary care setting with a likert scale of disagree to agree.
Measured: Baseline and at 4 Months
The Diabetes Self-Management Questionnaire (DSMQ) on eating, medication, glucose monitoring, physical activity, and healthcare use
Self-reported perception among patients of eating behavior, medication adherence, glucose monitoring, physical activity, and healthcare use with a likert scale of applies to me very much, applies to me a considerable degree, applies to some degree, and does not apply to me.
Measured: Baseline and at 4 Months
Secondary outcomes (8)
Weight
Weight in pounds
Measured: Baseline and at 4 Months
Height
Height in inches
Measured: Baseline and at 4 Months
Estimated glomerular filtration rate
The eGFR based on blood test.
Measured: Baseline and at 4 Months
Low-density lipoprotein Cholesterol
The LDL cholesterol based on blood test.
Measured: Baseline and at 4 Months
Blood Pressure
The systolic and diastolic blood pressure using blood pressure monitor.
Measured: Baseline and at 4 Months
Clinic Visit
The total count of clinic visits both virtually and on-site.
Measured: 4 Months
Hospitalizations
The total count of hospital admissions.
Measured: 4 Months
Costs of Implementation
Total estimated costs of implementing interventions using a budget impact analysis
Measured: 4 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start1 Dec 2024
- Primary completion31 Aug 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lawndale Christian Health Center
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Chicago
- Responsible party
- Principal investigator, Andrew Wang, Lawndale Christian Health Center
- Investigators
- Andrew Wang, Principal investigator, Lawndale Christian Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06517576
- Sponsor's protocol ID
- LCHC-ID-10
- Other IDs
- P30DK092949
- Status last verified
- Aug 2025
- First submitted
- 11 Jul 2024
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Weinstock RS, Aleppo G, Bailey TS, Bergenstal RM, Fisher WA, Greenwood DA, Young LA. The Role of Blood Glucose Monitoring in Diabetes Management. Arlington (VA): American Diabetes Association; 2020 Oct. Available from http://www.ncbi.nlm.nih.gov/books/NBK566165/
PubMed 33411424Schmitt A, Gahr A, Hermanns N, Kulzer B, Huber J, Haak T. The Diabetes Self-Management Questionnaire (DSMQ): development and evaluation of an instrument to assess diabetes self-care activities associated with glycaemic control. Health Qual Life Outcomes. 2013 Aug 13;11:138. doi: 10.1186/1477-7525-11-138.
PubMed 23937988Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.
PubMed 28851459
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Using Remote Monitoring With an Automated Patient Engagement System and a Self-Monitoring Program With Continuous Glucose Monitors to Address Health Disparities in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT06517576
- Acronym / sponsor ID
- LCHC-ID-10
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Type 2 Diabetes, Remote Patient Monitoring
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Lawndale Christian Health CenterUniversity, hospital or other
- Collaborators
- Northwestern University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Chicago
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 24 Jul 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.
Patient populations at community health centers, specifically Black or African American and Hispanic or Latino populations with Type 2 diabetes, experience significant health disparities. In particular, they have higher rates of diabetes-related complications and other related conditions such as myocardial infarction, cerebrovascular disease, kidney failure, blindness, neuropathy, and the risk of amputation. Diabetes affects 34 million adults in the US. Achieving a target HbA1c less than 8% can be challenging through diabetes management. Patients are able to monitor their blood glucose levels with devices such as blood glucose meters or continuous glucose monitors to facilitate diabetes management and glycemic control. Past studies have demonstrated that these devices are effective in engaging patients in the improvement of diabetes management. Current advancements in remote patient monitoring and self-monitoring have been observed to be effective in facilitating improvement in diabetes outcomes. However, the effectiveness and financial feasibility of these devices delivered in conjunction with automated patient engagement systems in remote patient monitoring programs is not well understood among underinsured, underserved, and vulnerable minority populations as they face a high-cost barrier particularly with continuous glucose monitors. To better address this gap in knowledge, this pilot study will compare and examine the effectiveness of these interventions on patient outcomes with Type 2 diabetes among populations in the West Side of Chicago. Study the comparative effectiveness among patients with uncontrolled Type 2 diabetes on insulin in an intervention group using remote patient monitoring and automated patient engagement system with blood glucose monitors to a group using a self-monitoring program with continuous glucose monitors and a usual care group receiving standard care. Conduct a feasibility analysis and financial impact of these programs among an underinsured and underserved population of Black/African Americans or Hispanic/Latinos with Type 2 diabetes.
Detailed description
This will be conducted at a Lawndale Christian Health Center, a community health center in the West Side of Chicago that serves a largely Black or African American and Hispanic or Latino population. To accomplish this objective, Aim 1 will study the impact on patients with uncontrolled Type 2 diabetes on insulin by comparing an intervention group that features remote patient monitoring with an automated patient engagement system and health coaching using blood glucose meters compared to a group that features a self-monitoring program using continuous glucose monitoring devices and a usual care group with standard care, and Aim 2 will examine the feasibility of implementing these interventions and financial impact of each treatment group at a community health center. To understand the effect of this study on health outcomes, patient level data will be examined including primary outcomes for health measurements such as HbA1c, blood glucose, BMI/weight, estimated glomerular filtration rate (eGFR), patient-reported outcomes including medication adherence, daily activities, diabetes self-management activities, and secondary outcomes for health measurements such as LDL cholesterol, systolic and diastolic blood pressures, as well as implementation outcomes such as acceptability, appropriateness, and feasibility. The costs of implementation and delivery will be examined using a budget impact analysis. This study will be essential for informing the impact on health disparities through remote monitoring with automated patient engagement compared to self-monitoring when providing care for underinsured and underserved populations.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Remote patient monitoring and automated patient engagement system with blood glucose monitors | Experimental | Device: Blood glucose monitor with Digital Platform and Health CoachingParticipants in this group will receive blood glucose monitors and will check their blood glucose daily with monitoring through a digital platform and provided health coaching. |
| Self-monitoring program with continuous glucose monitors | Experimental | Device: Continuous glucose monitorParticipants in this group will receive continuous glucose monitors and will self monitor their blood glucose measurements with support by their care team. |
| Usual care group receiving standard care | Active comparator | Other: Usual CareParticipants in this group will receive standard care for diabetes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age or older
- Have an assigned primary care provider
- Diagnosis of Type 2 diabetes
- Medication use is insulin
- HbA1c of 8.0% or higher
Key exclusion criteria (4 listed)
- Diagnosis of chronic kidney disease at Stage 4 or higher
- Diagnosis of pregnancy
- Diagnosis of behavioral health conditions including serious mental illness or severe depression in the past 6 months.
- All participants must have a smartphone that is able to access internet 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 |
|---|---|---|
| Blood glucose monitor with Digital Platform and Health CoachingAlso: Bluetooth Blood Glucose Monitor, 3011065399Blood glucose monitors will be used daily to measure blood glucose measurements. | Device | Remote patient monitoring and automated patient engagement system with blood glucose monitors |
| Continuous glucose monitorAlso: Dexcom G7 Continuous Glucose Monitoring System, 3004753838Continuous glucose monitors will be used daily to measure blood glucose measurements. | Device | Self-monitoring program with continuous glucose monitors |
| Usual CareUsual care for type 2 diabetes | Other | Usual care group receiving standard care |
Primary outcome
Glycated Hemoglobin
Time frame: Baseline and at 4 Months
HbA1c based on blood sugar attached to hemoglobin based on lab analysis of blood.
Blood Glucose
Time frame: 4 Months
Blood glucose measurements based blood glucose monitor (BGM) and continuous glucose monitor (CGMs).
Engagement with digital platform with a daily submission of blood glucose
Time frame: 4 Months
Daily blood glucose measurements from blood glucose monitor submitted to the digital platform
Implementation - Acceptability of Intervention Measure (AIM)
Time frame: Baseline and at 4 Months
Self-reported perception among patients that this service is agreeable, palatable, or satisfactory with a likert scale of disagree to agree.
Implementation - Intervention Appropriateness Measure (IAM)
Time frame: Baseline and at 4 Months
Self-reported perception among patients that this service is fit, relevant, and compatible with a likert scale of disagree to agree.
Implementation - Feasibility of Intervention Measure (FIM)
Time frame: Baseline and at 4 Months
Self-reported perception among patients that this service is successfully used or carried out within a primary care setting with a likert scale of disagree to agree.
The Diabetes Self-Management Questionnaire (DSMQ) on eating, medication, glucose monitoring, physical activity, and healthcare use
Time frame: Baseline and at 4 Months
Self-reported perception among patients of eating behavior, medication adherence, glucose monitoring, physical activity, and healthcare use with a likert scale of applies to me very much, applies to me a considerable degree, applies to some degree, and does not apply to me.
8 secondary outcomes
Weight
Time frame: Baseline and at 4 Months
Height
Time frame: Baseline and at 4 Months
Estimated glomerular filtration rate
Time frame: Baseline and at 4 Months
Low-density lipoprotein Cholesterol
Time frame: Baseline and at 4 Months
Blood Pressure
Time frame: Baseline and at 4 Months
Clinic Visit
Time frame: 4 Months
Hospitalizations
Time frame: 4 Months
Costs of Implementation
Time frame: 4 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Background: PubMed 33411424Weinstock RS, Aleppo G, Bailey TS, Bergenstal RM, Fisher WA, Greenwood DA, Young LA. The Role of Blood Glucose Monitoring in Diabetes Management. Arlington (VA): American Diabetes Association; 2020 Oct. Available from http://www.ncbi.nlm.nih.gov/books/NBK566165/
- Background: PubMed 23937988Schmitt A, Gahr A, Hermanns N, Kulzer B, Huber J, Haak T. The Diabetes Self-Management Questionnaire (DSMQ): development and evaluation of an instrument to assess diabetes self-care activities associated with glycaemic control. Health Qual Life Outcomes. 2013 Aug 13;11:138. doi: 10.1186/1477-7525-11-138.
- Background: PubMed 28851459Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.
- 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.
Andrew Wang principal investigator
Lawndale Christian Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood glucose monitor with Digital Platform and Health Coaching and Continuous glucose monitor in people with Diabetes Mellitus, Type 2, run by Lawndale Christian Health Center 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 5 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 11 Aug 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?
This study is still under way. Results are not available in the source record yet.
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?
Glycated Hemoglobin (time frame: Baseline and at 4 Months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06517576, which also lists 3 linked publications.
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 11 Aug 2025.