ADA Releases 2020 Standards of Care – December 20, 2019

Executive Highlights

  • The ADA today published its Standards of Medical Care in Diabetes for 2020 in Diabetes Care, coming in at a whopping 224 pages. We were thrilled to see GLP-1s and SGLT-2s now in consideration for CV/renal benefits independent of target or baseline A1c – although metformin remains as the organization’s choice for first-line treatment, we hope this is the start of far more focus on secondary cardiovascular disease prevention and renal disease-prevention.

  • As always, the guidelines provide a plethora of data-driven recommendations, and we recommend looking at the Summary of Revisions to get a rapid-fire look at what’s new. Due to improvements in the available levels of evidence in the past year, a number of recommendations have been updated and/or expanded.

  • New Hot Topics have been added within sections such as the care of type 2 diabetes (T2DM) in migrant agricultural workers, use of e-cigarettes, remote retinal screenings, increased guidance on the placement of DM meds that have cardio-vascular and/or renal benefits, management of type 1 diabetes (T1DM) in older adults, use of CGM during pregnancy and the care of patients with connected diabetes devices e.g. insulin pumps, sensors and closed loop systems in the inpatient setting.

  • Oral semaglutide, nasal glucagon, and liquid glucagon injections make their debuts in the Standards of Care. Though no recommendations were made by the ADA to promote recently approved agents over traditional ones, their ease of use and less invasive nature are attractive to most. While costs still limit access to these agents for some, many have found the reimbursement to be stronger over time and while the government limits patients on Medicare to use Patient Access Programs, anyone on private insurance can get a prescription of Rybelsus (oral semaglutide) for up to a year with a $10/month card.

  • Early combination therapy, and more choice in injectable therapies, were added to type 2 care algorithms and we certainly hope that this will drive uptake. While we felt it was unfortunate that the ADA did not recommend early combination over first-line therapy with metformin given VERIFY results, the ADA did at least highlight VERIFY results as support for early combination with Novartis’ vildagliptin (presumably this will be seen as a class effect). The irony is profound, of course, that this DPP-4 inhibitor was never approved in the US.

  • In another notable win for the CGM field and Beyond A1c movement, Time in Range, consensus CGM metric goals, and ambulatory glucose profiles (AGPs) were included in the 2020 Standards of Care in more detail than before. While CGM targets and AGP were also included in the August update to the 2019 Standards of Care, it was great to see this, there were more references in this volume. We believe some HCPs are still not well informed about the power of AGP (much less CGM) and how to interpret and utilize the data in clinical practice. We hope the added guidance will help significantly.

  • In addition to the CGM metrics and AGP goals, the new Standards of Care also highlight CGM and “CGM-assisted pump therapy” as tools for prevention of hypoglycemia. We believe the Standards of Care will continue to get even stronger in promoting technology that improves care and reduces burden and we hope to see much stronger adoption and uptake. We would like to see far more patients urged to use Professional CGM (often a gateway to personal CGM wear) and believe the new Standards can help.

  • In similar news, a 2019 update was also made to the 2018 ADA/EASD consensus report. The changes were just published in Diabetes Care and echo many of the changes in the ADA 2020 Standards of Care. In terms of major changes, committee members emphasized:

    • moving to treat high-risk individuals with a GLP-1 or SGLT-2 to reduce MACE, hHF, CV death, or CKD progression independently of A1c;

    • considering use of GLP-1s in patients with type 2 without established CVD but with the presence of specific high-risk factors (this was big);

    • recommending SGLT-2s in patients with type 2 and HF, particularly those with HFrEF, to reduce hHF, MACE, and CV death; and

    • recommending SGLT-2s in patients with type 2 and CKD to prevent the progression of CKD, hHF, MACE, and CV death.

The ADA today published its official Standards of Medical in Diabetes for 2020 in Diabetes Care. Here, we review and contextualize the most notable updates made from the 2019 Standards of Care, broken down by topic. We recommend looking at the Summary of Revisions to get a rapid-fire look at what’s new. This report contains ten items that struck us as notable; there are a number of areas not discussed in this report such as NPH insulin recommended for patients if they do not have access to other insulins, low-carb meals stressed as a key option for patients, etc.

Of note, this is the first year that the ADA Standards have been published without past CMSO Dr. Will Cefalu, who was the visionary behind making the Standards of Care a living document in 2018 and now has taken up the reins at the NIH. It is great to see that he had influenced such a strong Professional Practice Committee. Dr. Kenneth P. Moritsugu, the acting CSMO, has done a terrific job in moving forward these guidelines under the leadership of ADA CEO Tracey Brown.

Overall, the new Standards of Care move the field forward in important respects – while the standards do not have major changes like ESC’s (European Society of Cardiology) new standards in recommending GLP-1 and SGLT-2 as strong first line agents, there are some major changes. On the metformin front, we expect further debate in the future as more outcomes data emerges; while metformin doesn’t have the evidence of GLP-1 and SGL-2 inhibitors in cardiovascular- or renal (secondary) prevention, it has been used successfully for some time in many patients.

Broadly, we commend the ADA’s Professional Practice Committee on putting together this incredibly impressive document year after year. It is “volunteer work” for so many of the people who work on it, and HCPs and patients and systems benefit enormously. We’d like to see far more translation beyond Diabetes Care and hope that too will take place.

KOL Commentary

  • Dr. John Buse (Diabetes Care Center at UNC, Chapel Hill, NC): “This is a rapidly evolving area of research that the ADA and EASD studied intensively and debated vigorously. I do believe the new guidance is highly evidence based and provides a more evidence-driven approach to medication selection in the setting of type 2 diabetes with atherosclerotic cardiovascular disease, heart failure and chronic kidney disease than other recent efforts. The aim was to provide strong recommendations where the evidence of benefit is large and thus the greater expense of treating with GLP-1RA and SGLT2i is likely to have the greatest impact. That said, these newer, more expensive drugs certainly have attributes that make them attractive in a broader population of patients with type 2 diabetes. However, unique benefits on mortality, hospitalizations, events and progression of disease has not been studied for these medications in the general population of patients with type 2 diabetes with comorbidities who are not at the highest risk for cardiovascular events and progressive kidney disease.”

  • Dr. Sanjay Kaul (Cedars-Sinai Medical Center, Los Angeles): “The 2020 ADA Standards of Care, unlike 2019 ESC/EASD guidelines, continue to emphasize metformin as first-line therapy without robust and high-quality supportive evidence to mitigate either microvascular or macrovascular complications of type 2 diabetes. While it is relatively safe, inexpensive and easy to use, the quality and the quantity of evidence is not sufficient to elevate it to the lofty pedestal of first-line therapy.

The remaining recommendations, especially for CV risk mitigation, are generally faithful to the evidence except for the use of GLP1-RA in those in whom CKD or HF predominates and who are not eligible to take SGLT2 inhibitors. There are no robust data to support this recommendation and (not surprisingly) GLP1-RA are not approved for these indications.

A minor point is the qualification for HFrEF using LV EF cut-off of 45%. The DAPA-HF used 40% as the cut-off and EMPEROR program is also using this cut off. Otherwise, the recommendations look good to me.”

  • Dr. Anne Peters (USC): “The key to the success of any guidelines is helping implementation with our primary care colleagues.  Which is why we tried to make it clearer, even though it is not possible to make it simple.”

  • Dr. Silvio E. Inzucchi (Yale): “The new Standards of Care represent an evolution in the T2DM treatment guidelines from the ADA, based on a rapidly shifting evidence base. It was in 2016, soon after we published the surprising results from the EMPA-REG OUTCOME trial that the ADA guidelines began to acknowledge that certain glucose-lowering drugs might be preferred over others in those with established CVD.  As the evidence grew, mainly from large CV outcome trials involving SGLT2 inhibitors and GLP-1 receptor agonists, the recommendations became stronger, to the point that, in the joint Consensus Report from the ADA and the EASD from 2018, the first step in the algorithm after metformin was explicitly spelled out when additional glucose lowering was required in the setting of prevalent ASVCD (SGLT2i or GLP-1 RA), HF (SLGT2i) or CKD (SGLT2i). During this time, several papers have demonstrated that the benefits of these classes, particularly the SGLT2 inhibitors, is independent of their effect on glucose concentrations. That is, HbA1c is not an effect modifier for either CV or kidney benefits in these trials. Accordingly, some (mainly from the cardiology community) have questioned whether it makes any sense any longer to predicate the addition of these newer drugs on the need to improve HbA1c. Both the ACC and the ESC have developed guidelines over the past 1-2 years that bypass metformin as first-line therapy and also stipulate that the use of these now evidence-based therapies in T2DM should be driven by the underlying risk of the patient and not by how high the HbA1c might be.  While the new Standards of Care don’t go so far to advise these meds over metformin as first line therapy, they do recommend that they be used regardless of HbA1c.  Although I tend to agree with this approach, I would point out one flaw. This strategy has never been actually proven to be effective in a dedicated clinical trial. Instead, we are inferring this to be the correct approach from relatively small subgroups in these trials.  On the other hand, properly powered studies are unlikely to ever be conducted to specifically prove that this approach is valid. Accordingly, as in many areas of medicine, we are forced to interpret the data we have, often suboptimal, and then contextualize this for the patients we see in our practices.  One final point I would make is that the endorsement of GLP-1 RA therapy in HF or CKD patients if an SLGT2i cannot be used continues to befuddle me. There is zero evidence any benefit from the GLP-1 RA’s in HF and their effect in CKD is mainly on macroalbuminuria not (as is the case with the SGLT2i’s) on delaying the actual progression of renal dysfunction (i.e., fall in GFR.)”

  • Dr. Irl Hirsch (U Washington) “I am overall impressed by the continued evolution of the ADA's SOC. This is a monumental effort and the authors, as usual, did an outstanding job in assessing the evidence. I was delighted that LADA is now an official designation in the classification, as up until now many had not realized it had not been included in either ADA or the WHO classification. The most controversial part, as usual, will be the type 2 pharmacotherapy. I still wonder why we wait until an A1C of 10% or severe insulin deficiency with symptoms before starting insulin. While I agree it would be ideal to start everyone on a GLP1 RA for an A1C at 8.5% (assuming no ASCVD, or CKD), due to cost it is not realistic and setting the level at 10% for mandated insulin keeps too many in the 9's and 10s for too long. We still have too many coming into our clinic referred for insulin starts with A1C levels in the 12's--with a 9% A1C noted years before. With that being said, given the amount of new evidence in the fields of technology and CVOTs, this is a great document which unfortunately can't be made much less complicated given the complexity of what has happened in the field.”

  • Dr. Satish Garg (U Colorado): “I am not sure if metformin should continue to be the first line of therapy of diabetes. The only reason it will remain is because it is so cheap. Even though Time in Range makes more sense for day to day diabetes management, its adoption in clinical research and care will be slow, especially by the regulators, due to lack of prospective data like DCCT clinical trial. Implementation of CGM, automatic downloading, standardized reporting and proper understanding of the data require additional resources for better clinical outcomes. Even though off -label use of SGLT inhibitors continues in type 1 diabetes, new data from Europe (where they are approved) in the next year might help their approvals in the US.”

  • Dr. Deneen Vojta (UnitedHealth Group): "We applaud the release of the American Diabetes Association’s 2020 Standards of Care. At UnitedHealth Group, we support the ADA’s emphasis on intensive lifestyle interventions and other metabolic therapies that are proven to produce better outcomes for patients, which can lead to remission.

    Digital tools, including continuous glucose monitoring (CGM), support patients in making meaningful lifestyle changes like healthier food selections that patients enjoy and aid in disease control. We know changing behaviors and making healthier food choices can be difficult. Tools like real-time CGM provide patients with immediate information about their glucose levels and can empower patients to quickly adapt their diet and activity level.

    The 2020 Standards of Care also broaden “beyond A1C,” which is an important step forward. We are encouraged to see continued emphasis on other aspects of glycemic control such as time in range, as revealed by ambulatory glucose profile or CGM. We hope future recommendations for care will focus on other relevant physiological aspects such as fasting insulin levels, visceral fat and inflammatory load, which have significant consequences for a host of health issues beyond the diagnostic criteria of Type 2 diabetes.

    The 2020 recommendations allow for personalization to each patient's needs and capabilities, and recognize the role technology can play in meeting those needs. Work remains to be done to adapt these new tools to their best use, and to direct Type 2 diabetes treatment efforts at the most important physiological targets, not just the most familiar.”

  • Ralph DeFronzo (UT Health San Antonio): "The new ADA guidelines represent a significant advance, but they still are deficient in my opinion. I directed the metformin multicenter trials that eventuated in the approval of metformin by the FDA and like metformin very much. However, there are no credible data that metformin reduces cardiovascular events in any population or prevents/slows the progression of diabetic nephropathy. In believe that GLP-1 RAs should be first line therapy in diabetic patients with established cardiovascular disease or with high cardiovascular risk, while SGLT2i should be first line therapy in diabetic patients with chronic kidney disease or heart failure. Please note that the European Society of Cardiology, in collaboration with the EASD (2019) now recommends GLP-1 RAs and SGLT2i as first line therapy in diabetic patients with established cardiovascular disease or at high cardiovascular risk or with heart failure. I would take it a step further and state that GLP-1 RAs and SGLT2i should be used ahead of metformin, whether or not cardiovascular or renal disease is present.

    The ADA guidelines also continue to be deficient in their failure to recommend early initial combination therapy especially in poorly controlled type 2 diabetic patients, as was shown by us in EDICT. There also is no mention about using antidiabetic agents that specifically correct the underlying pathophysiology in type 2 diabetes. This truly would represent personalized medicine. Perhaps they have forgotten about the Ominous Octet."

Diabetes Therapy

1. ADA Recommends GLP-1/SGLT-2s for CV/Renal Benefit Independently of Baseline or Target A1c

Previously, the compounds had only been recommended if not at target. However, the new guidelines clearly state that “SGLT-2s or GLP-1s are not dependent on A1c lowering” and should be considered even for those at goal for proven cardiovascular benefit. In particular, patients with ASCVD, HF, or CKD were highlighted. We’re thrilled to see this notable paradigm shift in formalized writing, considering the outspoken support we’ve heard on this front. This recommendation follows evidence from many CVOTs that support the glucose-independent effects of these therapies in terms of reducing adverse CV/renal outcomes.

  • As expected, discussion of a number of CVOTs were included in this year’s edition. Trial results for (i) CREDENCE for J&J’s Invokana (canagliflozin), (ii) DECLARE for AZ’s Farxiga (dapagliflozin), (iii) REWIND for Lilly’s Trulicity (dulaglutide), and (iv) CARMELINA for Lilly/BI’s Tradjenta (linagliptin) are all now found in the Cardiovascular Disease and Risk Management section.

2. Metformin Remains Firmly Positioned as First-Line Therapy in Type 2 Treatment Algorithm.

We’ve been interested to see how the ADA would approach this year’s guidelines, given the ESC’s somewhat controversial (in some places stateside – there was also enthusiasm about it, particularly among cardiologists like Dr. Sanjay Kaul) decision to recommend first-line SGLT-2 or GLP-1 treatment over metformin in patients with high risk for or established CVD in its 2019 Guidelines on Diabetes, Prediabetes, and CVD. Some argue that the data to support metformin as a first-line treatment is not nearly as robust as that generated by the plethora of recent CVOTs for GLP-1s and SGLT-2s, while others emphasize that most participants in these trials were on a background of metformin and thus results cannot be generalized to exclude the stalwart medication. Of course, about 80% were on metformin, so we’d just like to see the “meta-math” on how patients did who were not on metformin. Overall, from our view, the ESC guidelines were not negative on metformin – they were just being data-driven and fact-based about the results in the CVOTs, which were more robust than results for metformin. Also, many patients go off metformin due to problems with titration (both side effects and efficacy), particularly when prescribed by PCPs. Although we see the power of an endo or PCP prescribing and explaining the benefits of metformin, especially to those who can’t afford the more expensive drugs, we also believe more coverage will come with stronger standards of care. Overall, many patients think the tradeoff of an easier-to-take, easier-to-prescribe, easier-to-titrate more potent drug that causes weight loss and no hypo is a no-brainer if they can get access – we so wish everyone could and that they would also hear the benefits of metformin.

That the ADA would stick to its roots on metformin perhaps is not surprising, given that the ESC decision came fairly recently. While ADA for now is keeping metformin firmly planted as the only first-line therapy of choice, we are not sure this will stay true forever and expect more debate may occur in the future depending on future outcomes data: “Metformin should be started at the time type 2 diabetes is diagnosed unless there are contraindications; for many patients (often depending on A1c, cardiovascular risk factors  and cost) this will be monotherapy in combination with lifestyle modifications. Metformin is effective and safe, is inexpensive, and may reduce the risk of cardiovascular events and death.”

3. VERIFY Data Highlighted as Support for Earlier Combination Therapy

As a reminder, results from VERIFY showed that early combination therapy with metformin and the DPP-4 vildagliptin delayed both time to initial treatment failure (median difference in time-to-failure vs. placebo: +25.8 months; HR: 0.51; 95% CI: 0.45-0.58; p<0.0001) and time to second failure (HR: 0.74; 95% CI: 0.63-0.86; p<0.0001) with decreased in-range glycemic management in the early combination therapy group. The ADA stressed that early combination therapy has only been empirically proven effective with vildagliptin, disqualifying the generalization to other oral therapies. Despite this, the new Standards do suggest that early combination should be considered in certain groups, primarily patients with A1cs 1.5-2% above target and established ASCVD, and who respond poorly to certain drugs. With this, if an A1c target is not achieved with metformin after three months, combination therapy can be initiated with a sulfonylurea, TZD, DPP-4, SGLT-2, GLP-1, or basal insulin. Otherwise, the treatment algorithm for glucose-lowering medication in type 2 diabetes has not changed significantly from the ADA/EASD consensus report for managing hyperglycemia in type 2 published in October 2018.

By comparison, the 2019 Standards of Care suggested also considering an insulin injectable combination (i.e. GLP-1 and basal or prandial/basal insulin) at this stage (if injectable therapy is needed to reduce A1c after behavioral intervention has not yielded desired effects). Selecting insulin as a first-line injection therapy in any situation is no longer recommended, as favor has shifted toward GLP-1 agonists because of their positive effects on diabetes-related complications. This recommendation stems from meta-analyses that have shown similar glucose-lowering capabilities between GLP-1s and insulin. However, GLP-1s are preferred due to their lower risk of hypoglycemia and weight loss potential; but this benefit is matched against high costs and tolerability issues (these are variable) related to GI side effects (which tend to dissipate over time). With this, basal analogs and bedtime NPH insulins have been recommended to be initiated prior to prandial insulin, to target lowering fasting blood glucose levels and likely promote lower-cost alternatives for patients. In the new guidelines, prandial insulin is only recommended if basal analog or bedtime NPH are ineffective at lowering glucose to reach A1c targets. This therapy then intensifies by moving to self-mixed/split, prandial, basal-bolus, or twice-daily premix insulin regimens, depending on patients’ characteristics and preferences. This choice at the most intense level is also a new addition, as previous algorithms were much more linear and step-wise. Overall, these changes emphasize individualized care that reflects potential for external issues (like affordability) that may limit access to different certain types of insulin for some (though fewer people are now limited due to increases in Patient Access Programs, those on Medicare are still not allowed by government rules to access them).

5. Nasal Glucagon, Oral Semaglutide, and More Make Standards of Care Debut

The updated ADA Standards of Care mentioned the recent approvals of oral semaglutide (Novo Nordisk’s Rybelsus) in the treatment of type 2 diabetes, and nasal glucagon (Lilly’s Baqsimi) and liquid glucagon injection (Xeris’ GVOKE pre-filled syringe and autoinjector) in the treatment of hypoglycemia in both type 1 and type 2 diabetes. Though these new products were not concretely incorporated into new guidelines (see above), they were introduced as varied treatment options for patients. 

  • Rybelsus (oral semaglutide) received FDA approval in September 2019, and Novo Nordisk initiated its specialist launch in 3Q19 with a full commercial launch planned for early 2020. Standards of Care cited that most individuals prefer oral medications, but the need for more potent injectable medications to confer positive effects in people with longer duration of diabetes persists. Of note, oral semaglutide must be taken before the first food, drink or medication of the day with no more than 4 ounces of water followed by a 30 minute wait before any food, drink or medication. As PIONEER 4 results support the efficacy of GLP-1s to help patients achieve glycemic targets, ADA/EASD made no reference to oral versus injectable in revised treatment paradigms. However, increased costs associated with newer treatment options, like oral semaglutide, can interfere with medication taking – highlighting the need for cost-reducing strategies to pair with new therapies.

  • Baqsimi (nasal glucagon) received FDA approval in July 2019, while the GVOKE pre-mixed, liquid, room stable glucagon received approval shortly afterward in September 2019. This quickly diversified the rescue glucagon landscape, giving patients many more options than traditional glucagon reconstitution kits. As with oral semaglutide, the ADA did not make any direct statements recommending patients with diabetes and their caretakers to pivot from reconstitution kits to less complicated glucagon products but did emphasize these new franchises’ ease of use. As in previous renditions of the Standards of Care, caregivers should be trained and prepared to administer glucagon in emergency situations, and we know these new products are easier for a wider variety of people to learn to use and administer in stressful situations in public places.

  • While not a new medication, we note the addition of data from Vascepa’s REDUCE-IT CVOT, as in the March update to the 2019 Standards of Care – particularly exciting news considering the recent FDA approval of Vascepa’s CV label expansion.

Diabetes Technology

1. In a notable win for CGM and the Beyond A1c movement, Time in Range, consensus CGM metric goals, and ambulatory glucose profiles (AGPs) were included in the 2020 Standards of Care. This follows the inclusion of CGM targets and AGP in the August update to the 2019 Standards of Care.

Following the Diabetes Care publication at ADAClinical Targets for Continuous Glucose Monitoring Data Interpretation: Recommendations From the International Consensus on Time in Range,” the 2020 Standards of Care will add Time in Range goals and standardized CGM metrics associated with AGP – very positive step towards patients and HCPs having an expanded and more actionable knowledge of  the data from our view.

Following the ATTD meeting in Berlin where Time in Range goals of >70% for type 1 and type 2 diabetes were established, with <4% below 70 mg/dl and <1% below 54 mg/dl, this was great to see. Next we’d like to see an even stronger focus on limitations of BGs over 250 mg/dl, since there is no reason for any patients to be over this level given the compelling evidence from the DCCT and UKPDS trials.

2. A discussion of CGM use for hypoglycemia prevention was added in the Glycemic Targets section.

The discussion includes both CGM and “CGM-assisted pump therapy” as technologies for hypoglycemia prevention, though it zooms in on real-time CGM; on intermittent scanning CGM (i.e., FreeStyle Libre), the section cites a 2018 study that showed no significant improvement in hypoglycemia in adults with type 1 diabetes. FreeStyle Libre 2 has added optional low alarms to its EU version, which certainly helps with hypoglycemia prevention – this is not yet approved in the US. Dexcom G6 and Medtronic’s Sugar.IQ already offer predictive low glucose alarms; the Dexcom G6/Tandem t:slim X2 predictive low glucose suspend system, (Basal-IQ) has extremely impressive real-world hypoglycemia results (just 17 minutes/day <70 mg/dl in 2,696 pediatric users).

3. The Glycemic Targets section calls for “standardized, one-page sensor glucose reports with visual cues such as the Ambulatory Glucose Profile” to be the standard printout for CGM devices.

As an example, the section includes a printout from the consensus goals publication in Diabetes Care. To our knowledge, the redesigned AGP report has not yet been incorporated into any CGM download’s software - yet. This will be amazing to see, particularly if it can be standardized among all the products. Primary care physicians, endocrinologists and diabetes care & education specialists (DCES) are facing multiple demands, heightened workflow, very weak reimbursement in many parts of the US; we’re very hopeful that AGP will see wider adoption as we know it’s been an enormously helpful tool to for all providers to learn and use as a tool to help their patients, for those who have used it. Dr. Roy Beck (Jaeb Center) and many other notable physicians and DCES are big fans of the AGP. At ISPAD 2019, he asked the rhetorical question comparing AGP with A1c: ““Would you rather have [AGP] or would you rather have one number that reflects someone’s average over the last three months, and may not even be an accurate average?” We don’t think there is yet full understanding of accuracy problems with A1c and we look forward to seeing that understanding expand.

4. The 2020 Standards of Care also call for “glucose management indicator (GMI) along with other CGM metrics” to provide a “much more personalized diabetes management plan.”

Of course, it will take time for patients, caregivers, and providers to learn these new metrics and incorporate them into practice, but metrics like Time in Range and GMI can provide so much more value for everyone, particularly around therapeutic interventions, nutritional interventions, and behavior change. We also believe that these stats can be incredibly meaningful in terms of preventing type 2 diabetes in the first place and even pre-diabetes, for those who have access (this is enabled by forward-thinking HCPs and pharmacists. Of course, these metrics are very intuitive, as GMI could be considered a “real-time estimated A1c” and Time in Range is the percentage of time spent within the target glucose range (70-180 mg/dl). Dr. Anne Peters (Keck School of Medicine) at CMHC 2019 gave her support for GMI: “I use GMI to say to patients, ‘Your measured A1c is 7.6%, but your GMI is 6.8%, so it shows that your last two weeks were better and you’re trending in the right direction.’ With [diabetes devices], we get data. Then, we have to interpret that data to ourselves, and more importantly, to our patients to help them change behavior and reach the targets.’”

We salute various manufacturers for keeping up with the “status quo” – Dexcom updated the Clarity app with Time in Range and GMI last April!


Table 6.2. Standardized CGM metrics for clinical care

  • Number of days CGM worn (recommend 14 days)

  • Percentage of time CGM is active (recommend 70% of data from 14 days)

  • Mean glucose

  • Glucose management indicator (GMI)

  • Glycemic variability (%CV) target ≤36% (Some studies suggest that lower %CV targets (<33%) provide additional protection against hypoglycemia for those receiving insulin or sulfonylureas.)

  • Time above range (TAR): % of readings and time >250 mg/dL

  • Time above range (TAR): % of readings and time 181-250 mg/dL

  • Time in range (TIR): % of readings and time 70-180 mg/dL

  • Time below range (TBR): % of readings and time 54-69 mg/dL

  • Time below range (TBR): % of readings and time <54 mg/dL

5. Diabetes Technology section highlights no “one-size-fits-all” approach to care; highlights not-for-profit websites for patients and providers to get information

In the opening of the Diabetes Technology section, the Standards of Care emphasize that there is no “one-size-fits-all” approach to diabetes care. In particular, differences in insurance coverage, device availability, patient interest and willingness to use devices, and providers’ ability to keep up with the rapid pace of change are highlighted. Of course, it is ideal when patients have the ability to use (or not use) diabetes devices, but cost, provider and patient technology literacy and payer preferences are certainly areas that will continue to have lots of influence. The Standards of Care highlight and “other not-for-profit websites” as resources where providers and patients can go for information. In the future, we believe peer-support communities may receive more visibility as well – we believe as more evidence is associated with coaching and other decision-support materials, we’ll see more inclusion on this.


--by Rhea Teng, Ursula Biba, Albert Cai, and Kelly Close