Clinical trial NCT06517576: Using Remote Monitoring to Address Health Disparities in Type 2 Diabetes
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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 Diabetes
Remote Patient Monitoring
Lead sponsor: Lawndale Christian Health Center
Sponsor class: OTHER
Collaborators: name: Northwestern University Feinberg School of Medicine
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: University of Chicago
First posted: 2024-07-24
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Glycated Hemoglobin
timeFrame: Baseline and at 4 Months
measure: Blood Glucose
timeFrame: 4 Months
measure: Engagement with digital platform with a daily submission of blood glucose
timeFrame: 4 Months
measure: Implementation - Acceptability of Intervention Measure (AIM)
timeFrame: Baseline and at 4 Months
measure: Implementation - Intervention Appropriateness Measure (IAM)
timeFrame: Baseline and at 4 Months
measure: Implementation - Feasibility of Intervention Measure (FIM)
timeFrame: Baseline and at 4 Months
measure: The Diabetes Self-Management Questionnaire (DSMQ) on eating, medication, glucose monitoring, physical activity, and healthcare use
timeFrame: Baseline and at 4 Months
Secondary outcomes:
measure: Weight
timeFrame: Baseline and at 4 Months
measure: Height
timeFrame: Baseline and at 4 Months
measure: Estimated glomerular filtration rate
timeFrame: Baseline and at 4 Months
measure: Low-density lipoprotein Cholesterol
timeFrame: Baseline and at 4 Months
measure: Blood Pressure
timeFrame: Baseline and at 4 Months
measure: Clinic Visit
timeFrame: 4 Months
measure: Hospitalizations
timeFrame: 4 Months
measure: Costs of Implementation
timeFrame: 4 Months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Lawndale Christian Health Center
state: Illinois
Study officials:
affiliation: Lawndale Christian Health Center
name: Andrew Wang
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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/
citation: Schmitt 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.
citation: Weiner 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.