Summary of Clinical Research on Remote Patient Monitoring & Diabetes

Clinical Research Demonstrates RPM Improves Diabetes Outcomes

Many diabetic patients are already used to taking blood sugar readings on a daily basis. With the rapid increase in telehealth and Remote Patient Monitoring (RPM), many studies are now demonstrating that sharing this data with clinicians through an RPM program can lower A1C levels. RPM enables more data analysis, structured health coaching and timely interventions that lead to better A1C management than patient self-monitoring.

Below is a summary of the clinical research on the role of telehealth and at-home interventions in managing A1C levels. Overall, there is growing evidence that telehealth has a powerful and promising role for RPM in managing diabetes. RPM can provide frequent access to glucose data before and after meals and activities. This creates a complete feedback loop for collecting and analyzing data, adjusting behaviors, and modifying treatment to improve outcomes.

In addition to glucometers, patients at risk for diabetes can use weight scales with an RPM program to help prevent diabetes. Clinical research has also supported the use of remote monitoring for diabetes prevention.

Optimize Health’s clients using RPM to manage blood glucose have produced results consistent with the clinical research. Diabetic patients have experienced an 11-point reduction in blood glucose measurements in just 2 months and a 20-point drop within 12 months.

Highlights of the Research Include:

  • Telemedicine is effective for improving HbA1c and thus, glycemic control in patients with type 2 diabetes. In addition, telemedicine interventions were also found to significantly improve other health outcomes as well as QoL scores.
  • Clinical trials evaluating the impact of telehealth remote patient monitoring on A1C among adults with type 2 diabetes that incorporated study elements, such as patient education, provider education, patient goals, feedback, interactive communication, and shared decision making, consistently achieved significant A1C improvements between study groups.
  • An HbA1c decrease of -1.15% (95% CI -1.84% to -0.45%), yielding an HbA1c value of 6.95% (SD 0.495), was shown in studies using 6-month "real-time video" interventions.
  • Asynchronous interventions were the most successful for patients diagnosed with T1DM…this systematic meta-review shows that telemetric interventions cause significant reduction in HbA1c levels and result in overall positive effects in T1DM management.
  • Blood glucose home telemonitoring technologies confer a statistically significant reduction in HbA1c of ~0.50% in comparison to usual care when used adjunctively to a broader telemedicine initiative for adults with type 2 diabetes.
  • An eHealth model incorporating a complete feedback loop with telehealth remote monitoring and paired glucose testing with asynchronous data analysis significantly improved A(1c) levels compared to usual care.
  • Results suggest that a virtual DPP [Diabetes Prevention Program, including RPM weight scale] can change the pattern of utilization and reduce costs in a Medicare population … Medical and pharmacy costs were consistently lower for participants in the post-program year.

 

How to Use this Research

Whether you have an existing RPM program or are considering launching one, we understand that you need to direct your limited resources to programs that are going to have a significant impact on clinical care. Physicians and ordering providers rely on the results of clinical research studies every day to make patient care decisions. The below studies can be used for a variety of purposes including:

  • Educating physicians on the clinical benefits of RPM
  • Justifying the investment of staff time and practice resources into launching or maintaining an RPM program
  • Improving RPM patient identification and onboarding based on patient populations that can benefit from RPM

Included Studies & Resources

Efficacy of telemedicine on glycaemic control in patients with type 2 diabetes: A meta-analysis
Source: World Journal of Diabetes

Telehealth Remote Monitoring Systematic Review: Structured Self-monitoring of Blood Glucose and Impact on A1C
Source: Journal of Diabetes Science and Technology

Clinical Improvements by Telemedicine Interventions Managing Type 1 and Type 2 Diabetes: Systematic Meta-review
Source: Journal of Medical Internet Research

Effect of Telemetric Interventions on Glycated Hemoglobin A1c and Management of Type 2 Diabetes Mellitus: Systematic Meta-Review
Source: 
Journal of Medical Internet Research

Telemetric Interventions Offer New Opportunities for Managing Type 1 Diabetes Mellitus: Systematic Meta-review
Source: JMIR Diabetes

Home telemonitoring for type 2 diabetes: an evidence-based analysis
Source: Ontario Health Technology Assessment Series

Remote Patient Monitoring and Clinical Outcomes for Postdischarge Patients with Type 2 Diabetes  
Source: Population Health Management

Association Between Weight Loss and Glycemic Outcomes: A Post Hoc Analysis of a Remote Patient Monitoring Program for Diabetes Management
Source: Telemedicine Journal and e-Health

The impact of telehealth remote patient monitoring on glycemic control in type 2 diabetes: a systematic review and meta-analysis of systematic reviews of randomised controlled trials
Source: BMC Health Services Research

Overcoming Clinical Inertia: A Randomized Clinical Trial of a Telehealth Remote Monitoring Intervention Using Paired Glucose Testing in Adults With Type 2 Diabetes
Source: Journal of Medical Internet Research

Patients, physicians benefit from remote blood glucose monitoring
Source: Healio

Effect of home blood pressure telemonitoring with self-care support on uncontrolled systolic hypertension in diabeticsg
Source:
American Heart Association Hypertension Journal

Prediabetes

Virtual Diabetes Prevention Program—Effects on Medicare Advantage Health Care Costs and Utilization
Source: American Diabetes Association

A Digital Diabetes Prevention Program (Transform) for Adults With Prediabetes: Secondary Analysis
Source: JMIR Diabetes

Results From a Trial of an Online Diabetes Prevention Program Intervention
Source: American Journal of Preventive Medicine


Efficacy of telemedicine on glycaemic control in patients with type 2 diabetes: A meta-analysis

Source: World Journal of Diabetes

Conclusion: The findings indicate that telemedicine is effective for improving HbA1c and thus, glycemic control in patients with type 2 diabetes. In addition, telemedicine interventions were also found to significantly improve other health outcomes as well as QoL scores. The results of the subgroup analysis emphasized that interventions in the form of telemonitoring, via a clinical treatment model and with a focus on biomedical parameters, delivered at a less than weekly frequency and 6 mo duration would have the largest effect on HbA1c reduction. This is in addition to being led by allied health, through modes such as video conference and interactive telephone, with an intervention engagement level > 70% and a drop-out rate between 10%-19.9%. Due to the high heterogeneity of included studies and limitations, further studies with a larger sample size is needed to confirm our findings.

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Telehealth Remote Monitoring Systematic Review: Structured Self-monitoring of Blood Glucose and Impact on A1C

Source: Journal of Diabetes Science and Technology

Abstract: The aim was to summarize research on telehealth remote patient monitoring interventions that incorporate key elements of structured self-monitoring of blood glucose (SMBG) identified as essential for improving A1C. A systematic review was conducted using the Medline, Cumulative Index to Nursing and Allied Health Literature, EMBASE, and OVID Medline databases with search terms “Telemedicine” AND “Monitoring, Physiologic” AND “Diabetes Mellitus, Type 2.” Study selection criteria included original randomized clinical trials evaluating the impact of telehealth remote patient monitoring on A1C among adults with type 2 diabetes and incorporated 1 or more essential elements of SMBG identified by the International Diabetes Federation (patient education, provider education, structured SMBG profile, SMBG goals, feedback, data used to modify treatment, interactive communication or shared decision making).

Fifteen studies were included, with interventions ranging from 3 to 12 months (mean 8 months) with sample sizes from 30 to 1665. Key SMBG elements were grouped into 3 categories: education, SMBG protocols, and feedback. Research incorporating 5 of the 7 elements consistently achieved significant A1C improvements between study groups. Interventions using more SMBG elements are associated with an improvement in A1C. Studies with the largest A1C decrease incorporated 6 of the 7 elements and computer decision support. Two studies with 5 of the 7 elements and active medication management achieved significant A1C decreases. Telehealth remote patient monitoring interventions in type 2 diabetes have not included all structured monitoring elements recommended by the IDF. Incorporating more elements of structured SMBG is associated with improved A1C.
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Clinical Improvements by Telemedicine Interventions Managing Type 1 and Type 2 Diabetes: Systematic Meta-review

Source: Journal of Medical Internet Research

Results:

From 1116 unique citations, we identified 31 eligible studies (n=15 high, n=14 moderate, n=1 weak, and n=1 critically low quality). We selected 21 SRs and MAs, 8 RCTs, 1 non-RCT, and 1 qualitative study. Of the 10 trials, 3 were categorized as real-time video, 1 as real-time video and audio, 4 as asynchronous, and 2 as combined intervention. Significant decline in HbA1c levels based on pooled T1DM and T2DM patients data ranged from -0.22% weighted mean difference (WMD; 95% CI -0.28 to -0.15; P<.001) to -0.64% mean difference (95% CI -1.01 to -0.26; P<.001). The intervention effect on lowering HbA1c values might be significantly smaller for patients with T1DM than for patients with T2DM. Evidence on the impact on BP, body weight, FBG, cost effectiveness, and time saving was smaller compared with HbA1c but indicated potential in some publications.

Conclusions:

Telemedical interventions might be clinically effective in improving diabetes control overall, and they might significantly improve HbA1c concentrations. Patients with T2DM could benefit more than patients with T1DM regarding lowering HbA1c levels. Further studies with longer duration and larger cohorts are necessary.

 

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Effect of Telemetric Interventions on Glycated Hemoglobin A1c and Management of Type 2 Diabetes Mellitus: Systematic Meta-Review

Source: Journal of Medical Internet Research

Results: Overall, 1647 citations were identified. After careful screening, 99 studies (n=15,939 patients; n=82,436 patient cases) were selected by two independent reviewers for inclusion in the review. Telemetric interventions were categorized according to communication channels to health care providers: (1) "real-time video" interventions, (2) "real-time audio" interventions, (3) "asynchronous" interventions, and (4) "combined" interventions. To analyze changes in HbA1c, suitable RCTs were pooled and the average was determined. An HbA1c decrease of -1.15% (95% CI -1.84% to -0.45%), yielding an HbA1c value of 6.95% (SD 0.495), was shown in studies using 6-month "real-time video" interventions.

Conclusions: Telemetric interventions clearly improve HbA1c values in both the short term and the long term and contribute to the effective management of T2DM. More studies need to be done in greater detail.

 

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Telemetric Interventions Offer New Opportunities for Managing Type 1 Diabetes Mellitus: Systematic Meta-review

Source: JMIR Diabetes

Results: We identified 17 (6 high quality and 9 moderate quality) eligible publications: randomized controlled trials (n=9), systematic reviews and meta-analyses (n=5), cohort studies (n=2), and qualitative publications (n=1). Of 12 studies, 8 (67%) indicated a (significant or nonsignificant) reduction in HbA1c levels; 65% (11/17) of the studies reported overall (mildly) positive effects of telemetric interventions by addressing all the measured outcomes. Asynchronous interventions were the most successful for patients diagnosed with T1DM, but no technology was clearly superior. However, there were many nonsignificant results and not sustained effects, and in some studies, the control group benefited from telemetric support or increased frequency of contacts.

Conclusions: Based on the currently available literature, this systematic meta-review shows that telemetric interventions cause significant reduction in HbA1c levels and result in overall positive effects in T1DM management. However, more specified effects of telemetric approaches in T1DM management should be analyzed in detail in larger cohorts.

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Home telemonitoring for type 2 diabetes: an evidence-based analysis

Research question: Is home telemonitoring of blood glucose for adults with type 2 diabetes more efficacious in improving glycemic control (i.e. can it reduce HbA1c levels) in comparison to usual care?

Conclusions: Based on low quality evidence, blood glucose home telemonitoring technologies confer a statistically significant reduction in HbA1c of ~0.50% in comparison to usual care when used adjunctively to a broader telemedicine initiative for adults with type 2 diabetes. Exploratory analysis suggests differences in effect sizes for the primary outcome when analyzing by subgroup; however, this should only be viewed as exploratory or hypothesis-generating only. Significant limitations and/or sources of clinical heterogeneity are present in the available literature, generating great uncertainty in conclusions. More robust trials in type 2 diabetics only, utilizing more modern technologies, preferably performed in an Ontario or a similar setting (given the infrastructure demands and that the standard comparator is usual care), while separating out the effects of other telemedicine intervention components, are needed to clarify the effect of emerging remote blood glucose monitoring technologies.


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Remote Patient Monitoring and Clinical Outcomes for Postdischarge Patients with Type 2 Diabetes  

Source: Population Health Management

Abstract: The objective of this study was to evaluate changes in clinical outcomes for patients with type 2 diabetes (T2D) after a 3-month remote patient monitoring (RPM) program, and examine the relationship between hemoglobin A1c (HbA1c) outcomes and participant characteristics. The study sample included 955 patients with T2D who were admitted to an urban Midwestern medical center for any reason from 2014 to 2017, and used RPM for 3 months after discharge. Clinical outcomes included HbA1c, weight, body mass index (BMI), and patient activation scores. Logistic regression was used to estimate the likelihood of having a postintervention HbA1c <9% by patient characteristics, among those who had baseline HbA1c >9%. Most patients experienced decreases in HbA1c (67%) and BMI (58%), and increases in patient activation scores (67%) (P < 0.001 in all 3 cases) at the end of RPM.

Logistic regression analyses revealed that among patients who had HbA1c >9% at baseline, men (odds ratio [OR] = 3.72; 95% confidence interval [CI], 1.43-9.64), those who had increased patient activation scores after intervention (OR = 1.05; 95% CI, 1.01-1.09), those who had higher baseline patient activation scores, and those who had a greater number of biometric data uploads during the intervention (OR = 1.02; 95% CI, 1.00-1.04) were more likely to have reduced their HbA1c to <9% at the end of RPM. RPM for postdischarge patients with T2D might be a promising approach for HbA1c control with increased patient engagement. Future studies with study designs that include a control group should provide more robust evidence.
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Association Between Weight Loss and Glycemic Outcomes: A Post Hoc Analysis of a Remote Patient Monitoring Program for Diabetes Management

Source: Telemedicine Journal and e-Health

Objectives: To identify predictors of weight loss and to examine the association between weight loss and hemoglobin A1C (HbA1C) outcomes for T2D patients who were enrolled in an RPM program for diabetes management.
Conclusions: This study revealed a notable relationship between weight loss and positive HbA1C outcomes for T2D patients in an RPM-facilitated diabetes management program, which pointed to the potential of integrating evidence-based lifestyle modification programs into future telemedicine programs to improve diabetes management outcomes.

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The impact of telehealth remote patient monitoring on glycemic control in type 2 diabetes: a systematic review and meta-analysis of systematic reviews of randomised controlled trials

Source: BMC Health Services Research

Results:  Evidence from pooling four systematic reviews found that telehealth interventions produced a small but significant improvement in HbA1c levels compared with usual care (MD: -0.55, 95% CI: -0.73 to − 0.36). The greatest effect was seen in telephone-delivered interventions, followed by Internet blood glucose monitoring system interventions and lastly interventions involving automatic transmission of SMBG using a mobile phone or a telehealth unit.

Conclusion: Current evidence suggests that telehealth is effective in controlling HbA1c levels in people living with type 2 diabetes. However, there is a need for better quality primary studies as well as systematic reviews of RCTs in order to confidently conclude on the impact of telehealth on glycemic control in type 2 diabetes.
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Overcoming Clinical Inertia: A Randomized Clinical Trial of a Telehealth Remote Monitoring Intervention Using Paired Glucose Testing in Adults With Type 2 Diabetes

Source: Journal of Medical Internet Research

Objective: The purpose of this study was to evaluate a telehealth remote monitoring intervention using paired glucose testing and asynchronous data analysis in adults with type 2 diabetes. The primary aim was change in glycated hemoglobin (A(1c))—a measure of overall glucose management—between groups after 6 months. The secondary aims were change in self-reported Summary of Diabetes Self-Care Activities (SDSCA), Diabetes Empowerment Scale, and Diabetes Knowledge Test.

Conclusions: An eHealth model incorporating a complete feedback loop with telehealth remote monitoring and paired glucose testing with asynchronous data analysis significantly improved A(1c) levels compared to usual care..

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Patients, physicians benefit from remote blood glucose monitoring

Source: Healio

Summary: After 90 days, researchers found that blood glucose testing frequency increased by 44%, and all participants shared all blood glucose testing data with their providers. The data revealed that 70% of participants had blood glucose readings out of range or did not test as often as recommended. Researchers were able to identify hypoglycemic events among 26% of participants and trends for hyperglycemia among 65% of participants and address these conditions immediately with an insulin dose adjustment or additional education at the next visit. Patients reported feeling more confidence in talking with providers and family members about diabetes and less isolation in their disease management.

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Effect of home blood pressure telemonitoring with self-care support on uncontrolled systolic hypertension in diabetics

Source: American Heart Association Hypertension Journal

Abstract: Lowering blood pressure reduces cardiovascular risk, yet hypertension is poorly controlled in diabetic patients. In a pilot study we demonstrated that a home blood pressure telemonitoring system, which provided self-care messages on the smartphone of hypertensive diabetic patients immediately after each reading, improved blood pressure control. Messages were based on care paths defined by running averages of transmitted readings. The present study tests the system's effectiveness in a randomized, controlled trial in diabetic patients with uncontrolled systolic hypertension. Of 244 subjects screened for eligibility, 110 (45%) were randomly allocated to the intervention (n = 55) or control (n = 55) group, and 105 (95.5%) completed the 1-year outcome visit.

In the intention-to-treat analysis, mean daytime ambulatory systolic blood pressure, the primary end point, decreased significantly only in the intervention group by 9.1 ± 15.6 mmHg (SD; P < 0.0001), and the mean between-group difference was 7.1 ± 2.3 mmHg (SE; P < 0.005). Furthermore, 51% of intervention subjects achieved the guideline recommended target of <130/80 mmHg compared with 31% of control subjects (P < 0.05). These improvements were obtained without the use of more or different antihypertensive medications or additional clinic visits to physicians. Providing self-care support did not affect anxiety but worsened depression on the Hospital Anxiety and Depression Scale (baseline, 4.1 ± 3.76; exit, 5.2 ± 4.30; P = 0.014).

This study demonstrated that home blood pressure telemonitoring combined with automated self-care support reduced the blood pressure of diabetic patients with uncontrolled systolic hypertension and improved hypertension control. Home blood pressure monitoring alone had no effect on blood pressure. Promoting patient self-care may have negative psychological effects.

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Virtual Diabetes Prevention Program—Effects on Medicare Advantage Health Care Costs and Utilization

Source: American Diabetes Association

Abstract: This study evaluated the impact of a virtual version of the Diabetes Prevention Program (DPP) on healthcare utilization and costs in a Medicare Advantage population. The program was offered during 2015 to a random sample of 9,497 individuals who had metabolic syndrome or prediabetes. Program enrollees (n=501) received a 12-month virtual DPP including a wireless scale, pedometer, nutrition tracker, educational lessons, health coaching, and peer group support through an online platform. Participants with available administrative claims data during the 12 months before and 24 months following program start (n=495, mean age=69 years; 64% female; 85% white) were propensity-score matched on demographic, behavioral, and clinical factors in a ratio of 1:1 to a comparison group (n=495, selected from 6,490; mean age=69 years; 58% female; 87% white) who did not receive the DPP. In the 24 months following DPP enrollment, participants averaged 0.2 inpatient admissions, 0.3 emergency department visits, and 12.2 physician visits, compared to 0.2, 0.4, and 12.0 for controls.

While the utilization values do not show a large change, a difference-in-differences regression analysis of total medical and pharmacy cost for 24 months following program start showed cost savings. The adjusted difference-in-differences effect on average cumulative cost difference was $1,110 per participant, or $46.25/month. Medical and pharmacy costs were consistently lower for participants in the post-program year. Pharmacy savings were statistically significant during the last 6 months, with a 24-month cumulative adjusted savings of $408. These cost estimates do not include the cost of the program. Results suggest that a virtual DPP can change the pattern of utilization and reduce costs in a Medicare population.

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A Digital Diabetes Prevention Program (Transform) for Adults With Prediabetes: Secondary Analysis

Source: JMIR Diabetes

Results: The sample (N=273) comprised people with prediabetes who completed 4 months of the Transform program. Participants included 70.3% women, with a mean age of 54.0 (SD 11.2) years. On average, participants decreased their weight by 13.3 lbs (6.5%) and their BMI by 1.9 kg/m2. On average, participants increased their exercise frequency by 1.7 days per week, and absenteeism was reduced by almost half a day per month.

Conclusions: These results suggest that the digital therapeutic DPP (Transform) is effective at preventing type 2 diabetes through a significant reduction in body weight and an increase of physical activity. A prospective, controlled clinical study is warranted to validate these findings.

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Results From a Trial of an Online Diabetes Prevention Program

Source: American Journal of Preventive Medicine

Results: From 1,182 invitations, 268 (23%) participants enrolled in online DPP. Among these, 158 (56%) completed eight or more modules; mean weight change was –4.7 kg at 6 months and –4.0 kg at 12 months. In a supplemental analysis of participants completing one or more sessions/modules, online DPP participants were most likely to complete eight or more sessions/modules (87% online DPP vs 59% in-person DPP vs 55% MOVE!, p < 0.001). Online and in-person DPP participants lost significantly more weight than MOVE! participants at 6 and 12 months; there was no significant difference in weight change between online and in-person DPP.

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Telecare Is A Valuable Tool For Hypertension Management: A Systematic Review And Meta-Analysis

Source: Blood Pressure Monitoring

Abstract: There is an increasing interest for using telecare (TC) in the management of hypertension. A systematic review to the use of blood pressure (BP) measurement in TC has been performed (Medline/PubMed, Embase, and Cochrane Library), selecting randomized clinical trials that compared TC with usual care (UC) for hypertension management (treatment and/or coaching). Nine randomized clinical trials were selected (n=2501, 61.4±0.6 years, 42±2.7% males). Overall there was a significant larger decrease in the TC group than in the UC group for systolic (5.2±1.5 mmHg; P<0.001) and diastolic BP (2.1±0.8 mmHg; P<0.01).

When studies were separated for antihypertensive treatment modification during the study (yes or no), systolic BP decrease difference between the TC and UC groups (ΔTC-ΔUC) tended to be significantly lower (5.1±2.9 mmHg lower) with treatment modification compared with nontreatment modification in which the ΔTC-ΔUC was 8.6±2.4 mmHg, P=0.07. TC led to a greater decrease in systolic and diastolic BP than UC. The differences between TC and UC for systolic BP tend to become larger when no treatment modification is applied. TC seems a valuable tool for hypertension management.

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Self-Monitoring Of Blood Pressure In Hypertension: A Systematic Review And Individual Patient Data Meta-Analysis

Source: PLoS Medicine

Conclusions: Self-monitoring alone is not associated with lower BP or better control, but in conjunction with co-interventions (including systematic medication titration by doctors, pharmacists, or patients; education; or lifestyle counseling) leads to clinically significant BP reduction which persists for at least 12 months. The implementation of self-monitoring in hypertension should be accompanied by such co-interventions.

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Conclusion

While the potential for RPM to positively impact our patient’s life is significant, it does require strong leadership, dedicated staff, and careful planning to implement successfully. Whether you are brand new to RPM or trying to re-energize an existing program, we hope this playbook has provided a foundation for understanding everything that is required for a successful launch or re-launch.

At Optimize Health, we believe strongly in the power of RPM to be a critical component in improving patient outcomes while lowering costs. We are always happy to talk to healthcare groups about our services or just answer questions about RPM in general.

For more information about RPM, please visit www.optimize.health or schedule a free consultation with one of our RPM experts.

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