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Defining a New Standard for Structured, Personalized Blood Glucose Checking

Dr. Bimal Shah

06.09.20

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Livongo clinical research proves value of BG checking for people with non-insulin treated Type 2 diabetes

Diabetes is a highly complex and challenging condition to manage. On any given day, a wide array of behavioral and physical factors can combine to affect blood glucose levels -- including diet, exercise, medications, sleep, stress, and more. As we come to better understand the interplay among these factors, we are also coming to recognize the role emerging technologies can play in teasing apart and systematically targeting them. Given the rapid pace of such digital health innovation, it’s unfortunate but perhaps not surprising that treatment guidelines and clinical practice often lag behind the latest evidence for effective intervention.

Such is the case with the ongoing debate around the efficacy of self-monitoring of blood glucose (SMBG) for people with non-insulin treated Type 2 diabetes (T2DM) where, until recently, reliance on analogue approaches has led to the entrenchment of certain fallacies and prevented millions of people from understanding the full benefits of monitoring.

The Value of Structured Checking: An Emerging Consensus

SMBG, commonly known as finger-stick checking, has been a pillar of diabetes care and treatment for decades. While the benefits of SMBG have been well demonstrated for those with Type 1 diabetes and insulin-treated T2DM, SMBG studies for people with non-insulin treated T2DM have been inconsistent in their findings due to inherent differences in trial design, populations, and interventions. But as Parkin, et al. point out in their comprehensive review of these studies, “the most significant issues of concern with the previous generation of SMBG studies...are the testing regimens (structure and/or intensity) employed and how the SMBG data were utilized.”

Despite these inconsistencies and limitations, the American Academy of Family Physicians (AAFP) and the Choosing Wisely initiative still recommend against SMBG for non-insulin treated T2DM. Their recommendations are grounded in the aforementioned generation of studies which were based on ineffective once-daily unstructured checking that lacks the kind of tech-enabled programmatic support and personalized interventions every Livongo Member receives. The recommendations also rely on unvalidated claims that SMBG causes people undue anxiety and stress and leads to high costs from strips and other supplies. Fortunately, a flood of more recent trial-based studies and a year-long research study conducted on Livongo’s platform are converging around a new consensus and defining a new standard of care.

Furthermore, byzantine formulary and reimbursement rules limit people with diabetes to only 90 strips for 90 days (essentially one strip per day) where guideline recommendations suggest people with diabetes check up to four times per day, or more if necessary or suggested by their physician. As a result, ‘strip rationing’ as a financial savings tool, to avoid out-of-pocket costs in between covered refills, inhibits evidence-based checking routines known to improve overall glycemic control which only furthers the fallacy that SMBG is not clinically impactful. In fact, according to a survey by T1 International, up to 38% of people with diabetes in the United States have rationed blood glucose testing supplies.

Over the past decade, 9 out of 10 published studies have contradicted earlier orthodoxy around SMBG, demonstrating that when SMBG regimens are structured, such as before and after meals or exercise, they are indeed statistically and clinically effective in reducing HbA1c levels. As Parkins, et al. define it in their literature review, structured SMBG refers to “an approach in which BG data are gathered according to a defined regimen, interpreted and then utilized to make appropriate pharmacologic and/or lifestyle adjustments.” In one of the most recent studies, for example, structured SMBG was associated with an A1c decrease of 1.1 points at twelve months compared with a 0.3 point reduction in a similar group who did not perform SMBG. The American Diabetes Association (ADA) has endorsed structured checking in its 2019 standards of care, noting that “glucose monitoring can provide insight into the impact of diet, physical activity, and medication management on glucose levels.” As William Polonsky, President and Co-Founder of the Behavioral Diabetes Institute, summarized the new consensus around structured SMBG, “With the right kind of structured approach to monitoring in combination with wrap-around personalized support and feedback, almost everyone living with diabetes can measurably benefit from checking.”

Livongo Research Points the Way to Unleashing the Full Potential of SMBG

In their latest guidelines for people with non-insulin treated T2DM, the International Diabetes Federation (IDF) endorses SMBG under the right conditions, summarizing that the regimen is “likely to be an effective self-management tool only when results are reviewed and acted upon by healthcare providers and/or people with diabetes to actively modify behavior and/or adjust treatment.” As results from our latest research demonstrates, Livongo’s platform meets these requirements for clinical success, and instills greater confidence in self-managing diabetes.

Bimal Blog Structured Checking Images 2-03 Figure 1. Example of a Livongo Member’s Structured Checking Plan

Unlike traditional analog meters that are unable to send data or provide any form of feedback, Livongo’s two-way cellular connected meter allows us to capture a complete record of a person’s BG data (complete with date and time stamps and meal tags), build a unique profile for each individual, and then deliver personalized insights at exactly the right moment (e.g., while taking a BG reading) to inform behavior changes that can help them stay healthy. With targeted Health Nudges, for example, we have been able to drive behavior change for before breakfast checking -- the most highly recommended monitoring pattern for understanding fasting BG -- with over 40% of our Members completing a check and adhering to this vital regimen.

Bimal Blog Structured Checking Images 1-02 Figure 2. Example of a Livongo Challenge encouraging before breakfast checking

To better understand and improve the efficacy of Livongo’s structured checking program for non-insulin treated people with T2DM, we conducted an analysis of 9,498 Members from this population who were engaged in structured checking over a period of 12 months. In addition to understanding efficacy, we also sought to test a set of unvalidated assumptions that are commonly used to recommend against the use of SMBG with this population. Here’s what we found:

Efficacy. Members saw a significant HbA1c reduction at 12 months (-0.74, p<0.001), showing that structured checking, when supported through personalized messaging and nudges, can provide significant value for this population.

Anxiety and Distress. Contrary to claims by some groups that SMBG leads to unnecessary anxiety, our clinically validated survey showed that our Members engaged in SMBG in fact saw reduced distress and improved diabetes empowerment, feeling increased confidence to manage their diabetes.

Cost. Prior arguments against SMBG pointing to the high cost of testing supplies consistently fail to account for the sizable downstream savings from an effective structured checking program. Livongo has demonstrated a $131 PMPM medical savings and positive ROI across its Member base, including 16% overall cost savings for T2DM members not on insulin, demonstrating that the cost savings from such a program far outweigh the cost of supplies. In fact, the Livongo program includes as many supplies as a Member needs, shipped directly to their home, actively encouraging regular utilization and structured checking.

Frequency. In the world of diabetes management and SMBG there is a common tendency to equate more checking with more value. However, we have demonstrated through our platform that the quality of checking trumps quantity and that the range of BG can be accurately assessed with daily structured checking. Checking in itself is not the therapeutic intervention, it is what people do with the information that drives to the clinical result. I will elaborate more on that notion in a later blog post.

Finally, our research found that non-insulin treated Members with T2DM still have hypoglycemic episodes that require intervention, countering prior assumptions. Nearly one-third of our Members in this population use sulfonylureas, and 22% have received alert calls from our coaches for out of range BG levels.

After years of playing catch-up, healthcare is in the midst of rapid digital transformation. The COVID-19 pandemic has only accelerated the pace of change as telemedicine and remote monitoring respond to exploding demand. For the 30 million Americans living with diabetes, our research has shown that a tech-enabled structured checking program that’s personalized to the individual can drive crucial behavior change and improve outcomes while lowering costs for all. As future trials are designed and treatment guidelines updated, it’s time that they incorporate and account for the role of emerging technologies in delivering a new standard of care.

This study was a collaborative effort among a number of Livongo researchers including Anoop Sangha, MD, Roberta James, MSTAT, and Wei Lu, PhD.

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