Using Remote Monitoring to Address Health Disparities in Type 2 Diabetes

NCT06517576 | Enrolling By Invitation DMC FDA Device

• 2 other identifiers: LCHC-ID-10P30DK092949
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Type 2 Diabetes; Remote Patient Monitoring

Outcome Measures

Primary Outcomes (7)

• Glycated Hemoglobin

  HbA1c based on blood sugar attached to hemoglobin based on lab analysis of blood.

  Baseline and at 4 Months

• Blood Glucose

  Blood glucose measurements based blood glucose monitor (BGM) and continuous glucose monitor (CGMs).

  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

  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.

  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.

  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.

  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.

  Baseline and at 4 Months

Secondary Outcomes (8)

• Weight

  Baseline and at 4 Months

• Height

  Baseline and at 4 Months

• Estimated glomerular filtration rate

  Baseline and at 4 Months

• Low-density lipoprotein Cholesterol

  Baseline and at 4 Months

• Blood Pressure

  Baseline and at 4 Months

Study Arms (3)

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.

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.

Device: Continuous glucose monitor

Usual care group receiving standard care

ACTIVE COMPARATOR

Participants in this group will receive standard care for diabetes.

Other: Usual Care

Interventions

Blood glucose monitor with Digital Platform and Health Coaching DEVICE

Blood glucose monitors will be used daily to measure blood glucose measurements.

Also known as: Bluetooth Blood Glucose Monitor, 3011065399

Remote patient monitoring and automated patient engagement system with blood glucose monitors

Continuous glucose monitor DEVICE

Continuous glucose monitors will be used daily to measure blood glucose measurements.

Also known as: Dexcom G7 Continuous Glucose Monitoring System, 3004753838

Self-monitoring program with continuous glucose monitors

Usual Care OTHER

Usual care for type 2 diabetes

Usual care group receiving standard care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lawndale Christian Health Center: lead
• Northwestern University Feinberg School of Medicine: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• University of Chicago: collaborator

Study Sites (1)

Lawndale Christian Health Center

Chicago, Illinois, 60623, United States

Location

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Andrew Wang

  Lawndale Christian Health Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Population Health Director

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: July 24, 2024
• Study Start: December 1, 2024
• Primary Completion: August 31, 2025
• Study Completion: September 30, 2025
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)