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Impact of Wearable Continuous Glucose Monitoring Technologies on Diabetes Management Across Diverse Populations

Executive Summary

Wearable continuous glucose monitoring (CGM) technologies represent a significant advancement in diabetes care compared to traditional monitoring approaches. This report synthesizes evidence regarding the impact of CGM on long-term glycemic control, patient adherence, and healthcare utilization across diverse diabetic populations. Research demonstrates that CGM provides substantial benefits in glycemic control for both type 1 and type 2 diabetes, with particularly notable improvements in reducing hypoglycemic events and increasing time in target glucose range. However, significant disparities exist in access to and adoption of these technologies among racial/ethnic minority groups and those from lower socioeconomic backgrounds. The report concludes with recommendations for addressing these disparities and maximizing the potential benefits of CGM across diverse diabetic populations.

Introduction

Diabetes management has traditionally relied on intermittent self-monitored blood glucose (SMBG) measurements to guide therapy decisions. However, this approach provides limited information about glucose trends and may miss significant hyperglycemic or hypoglycemic events. Continuous glucose monitoring (CGM) technologies have emerged as an alternative that offers more comprehensive glucose data, potentially improving both clinical outcomes and quality of life for people with diabetes 1.

This report examines the impact of wearable CGM technologies on three key aspects of diabetes management across diverse populations:

1. Long-term glycemic control

2. Patient adherence to monitoring regimens

3. Healthcare utilization patterns

Types of Wearable Continuous Glucose Monitoring Technologies

Overview of CGM systems

Continuous glucose monitoring systems typically consist of three primary components 1:

1. A monitor to display information (sometimes the patient's mobile device)

2. A sensor inserted into subcutaneous tissue

3. A transmitter that sends data to the monitoring device

CGM technologies have evolved significantly and can be categorized into different types:

Real-time CGM (RT-CGM)

1. Provides continuous glucose readings updated every few minutes

2. Features alerts for impending or actual hyperglycemia or hypoglycemia

3. Allows immediate intervention based on glucose trends

4. Examples include Dexcom G6, Medtronic Guardian systems

Intermittently Scanned CGM (IS-CGM)

1. Requires patient interaction with the device to obtain readings

2. May still provide alerts for hypoglycemia or hyperglycemia

3. Examples include the FreeStyle Libre system

Professional CGM

1. Healthcare provider-owned equipment used for retrospective analysis

2. Similar to a cardiac Holter monitor, collecting data for later analysis

3. Allows providers to obtain relatively unbiased glucose patterns during everyday life

4. Examples include FreeStyle Libre Pro and Dexcom G6 Pro (which can be used in blinded mode)

Impact on Long-term Glycemic Control

Type 1 Diabetes

Multiple randomized controlled trials demonstrate significant improvements in glycemic control with CGM use in type 1 diabetes:

1. The JDRF Continuous Glucose Monitoring Study showed a 0.53% reduction in HbA1c compared to usual care, with significant benefits primarily in adults over age 24 1

2. The DIAMOND study demonstrated a 0.6% lower HbA1c with RT-CGM versus SMBG in patients on multi-dose injection therapy 1

3. The GOLD trial found a mean difference in HbA1c of 0.43% favoring RT-CGM 1

Meta-analyses have consistently found modest but significant improvements in HbA1c (0.23-0.28% reduction) with CGM use, with larger treatment effects seen in patients with higher baseline HbA1c levels (>8%) 1.

Beyond HbA1c, CGM provides additional metrics of glycemic control, including:

1. Time in Range (TIR): The percentage of time glucose levels remain within target range (typically 70-180 mg/dl)

2. Time Below Range (TBR): The percentage of time spent in hypoglycemia

3. Glycemic variability measures

Studies consistently show improvements in these metrics with CGM use compared to traditional monitoring approaches:

1. The IMPACT trial demonstrated a reduction in time spent in hypoglycemia by nearly 90 minutes per day compared to SMBG 1

2. Multiple studies show increased TIR with CGM use 1

Type 2 Diabetes

Research on CGM use in type 2 diabetes shows promising results across various treatment regimens:

1. In patients treated with basal insulin and oral medications, Vigersky et al. found a 1.0% reduction in HbA1c with intermittent RT-CGM compared to 0.5% with SMBG alone, with effects persisting up to 40 weeks 1

2. The MOBILE study in patients with type 2 diabetes on basal insulin showed significant reductions in HbA1c, improved TIR, and reduced hypoglycemia with the Dexcom G6 system compared to usual care 1

3. A 10-week study in patients with type 2 diabetes on multiple daily insulin injections found greater HbA1c reduction with flash glucose monitoring compared to traditional monitoring (-0.82% vs. -0.33%) 1

Notably, CGM can serve as a motivational tool even for patients not on insulin therapy, potentially improving lifestyle modifications and self-management behaviors 1.

Hypoglycemia Management

CGM technologies have demonstrated particular efficacy in reducing hypoglycemia, especially in high-risk populations:

1. The IN CONTROL trial found that RT-CGM significantly reduced hypoglycemic events compared to SMBG in patients with type 1 diabetes and hypoglycemia unawareness, including a 9.8% reduction in events <70 mg/dl and 44% reduction in events <40 mg/dl 1

2. A study of 52 adults with type 1 diabetes and problematic hypoglycemia found 39% fewer severe hypoglycemic events with CGM compared to hypoglycemia avoidance education alone 1

These improvements in hypoglycemia detection and prevention represent a substantial advantage over traditional monitoring approaches, particularly for vulnerable populations at heightened risk for severe hypoglycemic events.

Patient Adherence and Acceptability

Adherence Rates

Patient adherence to CGM varies considerably across different populations and study contexts:

1. In adults with type 1 diabetes, CGM use rates of >90% have been reported in clinical trials after 52 weeks 1

2. Among adolescents and young adults, adherence tends to be lower, with only 68% of participants using CGM at least 5 days per week after 6 months in the CITY study 1

3. In real-world settings, persistent sensor use for 12 months has been reported as low as 30% in some multi-national studies 1

4. Using the French national claims database, a study of over 74,000 patients with type 1 or type 2 diabetes showed >98% persistence with intermittently scanned CGM at 12 months, suggesting high acceptability in real-world settings 1

Barriers to Adherence

Several factors influence CGM adherence and acceptance:

1. Cost and insurance coverage represent significant barriers, with more than 50% of potential users citing these as limitations 3

2. Device-related issues including skin reactions, adhesion problems, and the hassle of wearing devices contribute to discontinuation 1

3. Age and technological literacy impact adoption, with lower adherence among pediatric and adolescent populations 1

Patient-Reported Outcomes

While generic quality of life scores typically don't show significant improvements with CGM, more specific diabetes-related measures often demonstrate benefits:

1. Treatment satisfaction and flexibility are significantly improved with CGM use 1

2. Diabetes distress, hypoglycemia fear, and hypoglycemic confidence often show meaningful improvements 1

3. Patients using flash glucose monitoring report their treatment as more flexible and are more likely to recommend it to others compared to those using traditional monitoring 1

These findings suggest that beyond physiological metrics, CGM technologies may provide important psychological benefits for patients managing the daily burdens of diabetes.

Healthcare Utilization

The impact of CGM on healthcare utilization represents a promising dimension of these technologies:

Emergency Care and Hospitalizations

Multiple real-world studies demonstrate reductions in acute diabetes-related healthcare utilization:

1. A study using the French national claims database found 39-49% reduction in hospitalizations for acute complications and a 32-40% reduction in diabetes-related coma following initiation of intermittently scanned CGM, with reductions persisting after 2 years 1

2. In Belgium, a nationwide reimbursement policy for intermittently scanned CGM was associated with significant reductions in hospital admissions for acute complications (severe hypoglycemia or ketoacidosis) 1

3. Among over 41,000 patients with insulin-requiring diabetes in an integrated health system, CGM initiation was associated with reduced emergency department visits or hospitalizations for hypoglycemia (adjusted difference -2.7%) 1

4. In a Medicare and commercial claims database study of patients with type 2 diabetes on multiple insulin injections daily, intermittently scanned CGM was associated with a 61% reduction in acute diabetes events and a 32% reduction in all-cause hospitalizations at 6 months compared to the pre-CGM period 1

Outpatient Visits

CGM may also impact patterns of routine healthcare utilization:

1. CGM use has been associated with reductions in the number of outpatient visits and increases in telephone/virtual visits 1

2. This shift toward virtual care models represents a potential efficiency gain for both healthcare systems and patients

Cost-Effectiveness

While comprehensive cost-effectiveness data across healthcare systems is still emerging, preliminary evidence suggests potential economic benefits:

1. In patients with type 2 diabetes treated with insulin or sulfonylurea who had recent myocardial infarction, intermittently scanned CGM was reported to be cost-effective while reducing time below range by 80 minutes daily 1

2. The substantial reductions in acute care utilization observed in real-world studies suggest potential for significant cost savings, though more research is needed to quantify these benefits across diverse healthcare systems and populations

Disparities in CGM Access and Utilization

Despite the demonstrated benefits of CGM technologies, significant disparities exist in access and utilization across diverse populations:

Racial and Ethnic Disparities

Multiple studies document lower CGM use among racial and ethnic minorities:

1. CGM use is significantly lower in Black and Hispanic individuals with type 1 diabetes compared to White individuals across all age ranges 3

2. These disparities persist even after adjusting for socioeconomic status, education level, insurance coverage, health literacy, numeracy, and diabetes clinical factors 3

3. A retrospective clinic-based cohort study found that Black adults were less likely than non-Black adults to use CGM at baseline (7.9% vs. 30.3%), initiate CGM over time (43.6% vs. 72.1%), and discuss CGMs with their provider (79.6% vs. 91.7%) 3

Contributing Factors to Disparities

Several factors contribute to these disparities in CGM access and utilization:

1. Provider-Level Barriers:

   1. Implicit and explicit bias may influence providers' perceptions of patients' interest, willingness, capacity, and financial ability to use CGM 3

   2. Studies document provider implicit bias in recommending diabetes technology based on insurance status and race/ethnicity 3

   3. Black patients are less likely to discuss CGMs with their providers and receive CGM prescriptions compared to non-Black patients 3

2. Health System/Structural Barriers:

   1. Limited healthcare access and suboptimal quality of care among marginalized populations 3

   2. Social determinants of health including socioeconomic status, neighborhood environment, food access, and social contexts 3

3. Insurance and Cost Barriers:

   1. High CGM cost and restrictive insurance policies represent significant barriers 3

   2. Medicaid policies for CGM coverage vary widely by state, with some requiring extensive documentation, limiting prescribers to specialists, or requiring difficult procurement processes 3

   3. Medicaid enrollees are least likely to use CGM, with particularly low rates among Black and Hispanic individuals 3

These disparities highlight a concerning equity gap in diabetes technology access that may exacerbate existing health disparities in diabetes outcomes.

Implications and Recommendations

Clinical Practice Recommendations

Based on current evidence, several recommendations can be made for clinical practice:

1. Universal Consideration of CGM: All patients who meet clinical criteria should be considered for CGM regardless of race, ethnicity, or socioeconomic status 3

2. Targeted Education and Support: Healthcare systems should develop structured education programs that address the specific needs and barriers of diverse populations 1

3. Integration with Virtual Care: CGM should be leveraged as a component of virtual diabetes care models to increase access and reduce barriers related to transportation or frequent in-person visits 3

4. Standardized CGM Data Reporting: The Ambulatory Glucose Profile and standardized metrics should be used to facilitate interpretation across diverse clinical settings 1

5. Provider Training on Bias: Healthcare systems should implement training to address implicit bias in technology recommendations 3

Policy Recommendations

Addressing disparities in CGM access requires policy-level interventions:

1. Expanded Insurance Coverage: Medicaid and private insurers should standardize and expand CGM coverage criteria, particularly for vulnerable populations 3

2. Simplified Access Pathways: Streamlining the process for obtaining CGM through pharmacy benefits rather than durable medical equipment suppliers could reduce time-to-initiation barriers 3

3. Incentives for Equity: Healthcare systems should implement incentives for equitable technology prescription practices 3

Conclusion

Wearable continuous glucose monitoring technologies demonstrate significant benefits for glycemic control across diverse diabetic populations compared to traditional monitoring approaches. The evidence consistently shows improvements in HbA1c, time in range, and reduction in hypoglycemia for both type 1 and type 2 diabetes. These benefits extend to healthcare utilization, with substantial reductions in emergency care and hospitalizations for acute diabetes complications.

However, concerning disparities exist in CGM access and utilization, particularly among racial and ethnic minorities and those with lower socioeconomic status. The barriers to equitable CGM distribution include provider bias, health system barriers, and restrictive insurance policies. Addressing these disparities through targeted interventions at provider, health system, and policy levels is essential to ensure that all individuals with diabetes can benefit from these advances in monitoring technology.

As CGM technology continues to evolve and becomes increasingly integrated with telehealth and automated insulin delivery systems, ensuring equitable access across diverse populations will be critical to preventing the widening of existing diabetes health disparities.

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