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

Overview

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.

Interventions

• Device Blood glucose monitor with Digital Platform and Health Coaching
  Blood glucose monitors will be used daily to measure blood glucose measurements.
• Device Continuous glucose monitor
  Continuous glucose monitors will be used daily to measure blood glucose measurements.
• Other Usual Care
  Usual care for type 2 diabetes

Primary outcome measures

• Glycated Hemoglobin [Time frame: Baseline and at 4 Months]
• Blood Glucose [Time frame: 4 Months]
• Engagement with digital platform with a daily submission of blood glucose [Time frame: 4 Months]
• Implementation - Acceptability of Intervention Measure (AIM) [Time frame: Baseline and at 4 Months]
• Implementation - Intervention Appropriateness Measure (IAM) [Time frame: Baseline and at 4 Months]
• Implementation - Feasibility of Intervention Measure (FIM) [Time frame: Baseline and at 4 Months]
• The Diabetes Self-Management Questionnaire (DSMQ) on eating, medication, glucose monitoring, physical activity, and healthcare use [Time frame: Baseline and at 4 Months]

Secondary outcome measures (8)

• 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]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Factorial

Masking

Open label

Primary purpose

Prevention

Study locations

United States · 1 center

• Lawndale Christian Health Center — Chicago

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/ PMID 33411424
• 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. PMID 23937988
• 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. PMID 28851459

Identifiers

NCT: NCT06517576 · LCHC-ID-10 · P30DK092949

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗