Highlights from EASD 2020

By Eliza Skoler, Matthew Garza, June Dong, Sophie Skallerud, and Elaine Young

Highlights from last week’s European Association for the Study of Diabetes’ (EASD) virtual 2020 conference included announcements on the Guardian Sensor 4 Continuous Glucose Monitoring (CGM) and the Omnipod 5 Automated Insulin Delivery (AID) system, new data on the importance of time in range, and updated recommendations on SGLT-2s, GLP-1s, and combination therapies

People across the world tuned in to the European Association for the Study of Diabetes’ (EASD) virtual 2020 conference. Leading researchers, healthcare professionals, and diabetes advocates shared the newest data on diabetes management, discussed time in range, announced upcoming technology and clinical trials, and visited 25 exhibit halls.

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Diabetes Technology Doesn’t Stop – Announcement after Announcement

• Medtronic announces a new CGM: Guardian Sensor 4

• Omnipod 5 Hybrid Closed Loop pivotal trial is complete

• Dexcom G6 real-world evidence shows 59% average time in range, low hypoglycemia, and high CGM use

• Data shows just how much CGM can benefit all people with diabetes

• Roche’s diabetes management platforms show promise

Diabetes Therapy

• GLP-1 Rybelsus can be a cornerstone treatment for type 2 diabetes

• Combination therapy recommendations for people with type 2 diabetes

• Ultra-rapid insulin Lyumjev lowers glucose and reduces hypoglycemia in pump users with type 1 diabetes

• INNODIA research initiative standardizes type 1 diabetes research in Europe

Big Picture: Time in Range and COVID-19

• Landmark data: more time in range is associated with fewer microvascular complications

• Time in range linked to heart health and severe hypoglycemia reduction

• COVID-19 and diabetes: what we know for people with type 1 and type 2 diabetes

Diabetes Technology Doesn’t Stop – Announcement after Announcement

Medtronic announces a new CGM: Guardian Sensor 4

In exciting news, Medtronic announced the Guardian Sensor 4, a new continuous glucose monitor (CGM). Though it is still being designed, Medtronic intends to distinguish the Guardian Sensor 4 from the Guardian Sensor 3 with three key elements:

• Zero required calibrations. No fingerstick CGM calibrations will greatly improve the user experience.

• Non-adjunctive indication. This means that users will be able to take insulin based on their CGM readings alone, without using a meter to confirm glucose levels.

• More accurate low sensor sugar measurements.

The updated CGM will be part of Medtronic’s MiniMed 780G system, a second-generation automated insulin delivery (AID) system that will launch soon in Europe. The MiniMed 780G adjusts basal insulin rates every five minutes and can automatically deliver correction boluses.

The Guardian Sensor 4’s non-adjunctive indication will be especially important for people with diabetes who have Medicare insurance. The indication will enable Medicare to cover use of the MiniMed 670G and MiniMed 770G AID systems with the Guardian Sensor 4 CGM. This is a major step towards making diabetes technology more affordable and more accessible.

Omnipod 5 Hybrid Closed Loop pivotal trial is complete

The pivotal trial for Insulet’s Omnipod 5 hybrid closed loop, also known as Omnipod Horizon, is now complete – meaning that the technology is one step closer to becoming available for people with diabetes. Though the trial experienced a delay earlier this year, Insulet plans to share the results in February 2021 and to launch the system in the US before July 2021.

Omnipod Horizon is an automated insulin delivery (AID) system that will integrate, or combine, the Omnipod 5 patch pump (worn for three days at a time) with a continuous glucose monitor (CGM) to predict sugar levels and dose insulin. Omnipod Horizon will first become available with the Dexcom G6 CGM, and later with Abbott’s FreeStyle Libre 2 CGM – it will be the first AID system with two CGM partners. The system will be controlled via a smartphone app (or through a special device, for people who don’t use smartphones). Insulet is focusing on making the system user-friendly and simple, with alarms and adjustable glucose targets (set between 100 and 150 mg/dl) allowing people new to AID to “ease” into the therapy by beginning with higher set points and working their way down.

You can read more about the Omnipod Horizon here.

Dexcom G6 real-world evidence shows 59% average time in range, low hypoglycemia, and high CGM use​

Dexcom data scientist Robert Dowd shared results from a real-world data set of 9,216 Dexcom G6 users. The large sample included both adults and children with type 1 and type 2 diabetes:

• Average time in range (TIR): people with type 1 diabetes had an average of 57% TIR (about 14 hours each day), and people with type 2 diabetes had an average of 62% TIR (about 15 hours each day). Neither group is meeting the consensus target of more than 70% TIR (about 17 hours per day).

• Hyperglycemia (glucose levels above 250 mg/dl): people with type 1 diabetes spent 14.3% of time in hyperglycemia, and people with type 2 diabetes spent 13.8% of time in hyperglycemia. The target for people with diabetes is to spend less than 5% of their time with glucose values above 250 mg/dl.

• Hypoglycemia (glucose levels below 70 mg/dl): people with type 1 and type 2 diabetes spent about 2% of their time with glucose levels below 70 mg/dl. This met the goal of less than 4% of time in hypoglycemia, and was much more encouraging than the hyperglycemia data.

• Among people with type 1 and type 2 diabetes, more than 86% of people used their CGM consistently. Many also share their CGM data with care-partners: 63% of those with type 1, and 40% of those with type 2 shared their data.

Data shows just how much CGM can benefit all people with diabetes

As many in the diabetes field work to give more people with diabetes access to continuous glucose monitors (CGM), several sessions and posters at EASD 2020 showed data on the benefits of CGM use in different populations. CGM was found to improve both diabetes management and quality of life:

• Dr. Hood Thabit talked about the benefits of CGM use in children, teenagers and young adults. Across three studies (SENCE, CITY, and MILLENIAL), CGM reduced the amount of time participants spent with glucose levels above 180 mg/dl, improved their time in range (TIR), and reduced hypoglycemia. All three studies also showed that participants spent the majority of the time wearing their sensors.

• Dr. Thabit also presented data from the WISDM trial in people over the age of 60 years with diabetes. After the six-month study, participants using the Dexcom G5 CGM spent significantly more time each day in-range, compared to those measuring their glucose with by finger stick blood glucose monitoring (SMBG): 15 hours per day with CGM, versus 13 hours per day with SMBG (p<0.001). Additionally, people using CGM saw a significant reduction in severe hypoglycemic events and an overall reduction in time spent in hypoglycemia. Furthermore, the trial was extended for an addition six months to allow those who desired to continue to use CGM.  The reasons for the continued use were that the participants had high levels of trust in the CGM data and satisfaction with the use of CGM as a tool to manage their diabetes.

• Dr. Addie Fortmann and Dr. Bill Polonsky found that certain behaviors around CGM data sharing resulted in higher quality of life. Their online survey included 302 adults with type 1 diabetes using the Dexcom G5 or G6 CGM with its Share feature. 81% of the respondents said that their main share partner was their spouse or partner, and 70% of the respondents had a prior conversation with their share partner about how to best respond to their CGM data. Most importantly, the survey results showed that frequent “encouraging” and “celebrating” by the person following the CGM data were linked to lower A1C levels and less severe hypoglycemia, as well as improved quality of life.

• One of the main benefits of CGM is that it can easily measure time in range (TIR, glucose levels between 70-180 mg/dL), an increasingly common metric of day-to-day diabetes management. Dr. Pieter Gillard presented a poster that linked higher TIR with improved measures of Quality of Life (QOL) in the Belgian RESCUE trial’s 515 adults with type 1 diabetes using insulin pumps. Lower TIR was correlated with more diabetes-related emotional distress. Measures of  QOL need further investigation to determine their relationship to TIR, which could further validate the importance of TIR as a primary diabetes outcome measure. 

Roche’s diabetes management platforms show promise

During its company presentation, Roche showcased several of their tools for digital health and personalization of care, including their integrated personal diabetes management (iPDM) platform, their new Glycolytics app, the Accu-Chek SugarView app, and their RocheDiabetes InsulinStart service.

Roche presented real-world data from 19,475 people with diabetes using its iPDM platform over four years. The digital platform integrates a person’s diabetes data with their medical records and treatment plans. People using iPDM showed:

• An average A1C reduction of 1.3 percentage points. After only one year, A1C reductions averaged 0.5 percentage points (from a baseline A1C of 8.5%).

• 8% fewer hypoglycemia events, and reduced diabetes complications and death with iPDM use.

• Both people with diabetes and their healthcare teams reported improved satisfaction with care.

The iPDM platform also includes a new remote monitoring system that looks at patterns in a person’s diabetes data and alerts their healthcare professionals if the data suggests an adverse trend. In addition, it allows for the personalization of digital care tools and direct communication between healthcare providers and the people they treat.

Roche touched on three other exciting digital services:

• The Glycolytics app – this new app will integrate a person’s data from their blood glucose meter, Fitbit activity tracker, healthcare professionals, and medical records, using a special algorithm to predict “nighttime hypoglycemia and after-meal glucose” levels. This could be helpful for people who self-monitor blood glucose levels in predicting potential adverse events and less than optimal glucose readings!

• The Accu-Chek SugarView app – this app is designed for people with diabetes in areas with very little access to medical care. Users take a photo of their Accu-Chek test strip, upload it to the app, and are given information to help them understand their glucose values and the factors that might be affecting their glucose levels. SugarView is already available in Nigeria, the Philippines, Mexico, India, and Pakistan.

• The RocheDiabetes InsulinStart service – this program helps people who are transitioning from oral diabetes medications to insulin. The service sends people text messages reminding them to check their glucose levels; when a user responds, this helps calculate insulin dosing. This program is important for supporting people who are starting insulin therapy.

Diabetes Therapy

GLP-1 Rybelsus can be a cornerstone treatment for type 2 diabetes

GLP-1 agonists are a powerful type of diabetes drug that works to lower  glucose levels in people with type 2 diabetes. Most GLP-1’s are taken by injection, however, Rybelsus (semaglutide) is the first FDA-approved GLP-1 pill. In a session on Novo Nordisk’s Rybelsus, presenters used data from the PIONEER trials to discuss the safety and efficacy of this medication:

• Regardless of baseline A1C, people taking Rybelsus experienced reductions in their A1C.

• A1C levels decreased regardless of age, background medication, race or ethnicity, and how long someone had diabetes.

Rybelsus was also successful for improving diabetes management in people with kidney disease and high risk of heart disease:

• In PIONEER 5, people with moderate kidney disease taking Rybelsus showed major decreases in A1C and body weight.

• In a combined analysis of several trials, Rybelsus and GLP-1 Victoza decreased the risk of stroke for people with type 2 diabetes and high risk of heart disease. The results from these trials also suggested there was a benefit of early treatment with a GLP-1 medication.

Read more about Rybelsus here.

Combination therapy recommendations for people with type 2 diabetes 

Primary Care Diabetes Europe (PCDE) published new guidelines for primary care physicians treating people with type 2 diabetes, focusing on protecting people who may be at risk for heart disease. PDCE encouraged the use of early combination therapy (prescribing metformin with an SGLT-2 or GLP-1) instead of prescribing first one medicine, waiting until glucose levels rise, and then adding an addition medication. This approach aims to get heart-protecting medications to people early in the course of their diabetes.

The guidelines recommend determining whether someone with type 2 diabetes has “very high cardiovascular risk,” “high cardiovascular risk,” or is “elderly/frail” to decide what treatment strategy is best for them.

• A person should be classified as very high risk if they have a history of cardiovascular events, risk factors like high blood pressure, obesity, or smoking, decreased kidney function (an eGFR below 60 ml/min/1.73m²⁾, albuminuria), or early onset diabetes. Dr. Kamlesh Khunti showed that people with early onset type 2 diabetes (diagnosed before age 40) have a 14 times greater risk of heart attack and a 30 times greater risk of stroke than people without diabetes. For these people, combination therapy is strongly encouraged.

• People with type 2 diabetes who are not “very high risk” can be considered “high risk,” given the close association of diabetes and heart disease. The treatment recommendation for people with high risk is combination therapy of metformin with either a GLP-1 drug, an SGLT-2 drug, or a DPP-4 drug. For older people in this category, metformin is recommended first.

In another session, Dr. Vivian Fonseca used real-world data to investigate the benefits of combination therapy of basal insulin plus a GLP-1 agonist medication for glucose management. Analysis of data from more than two thousand people with type 2 diabetes and an A1C above 10% showed that those who started both basal insulin and a GLP-1 within 30 days reached an A1C target of 7% to 8% (or saw a reduction in their A1C level) more frequently than people who started the two drugs within 31-90 days. These findings suggest that not only is this combination therapy effective for lowering A1C levels, but the combination is most helpful early within a month of diagnosis (instead of waiting to measure the success of one drug before adding the other).

Ultra-rapid insulin Lyumjev lowers glucose and reduces hypoglycemia in pump users with type 1 diabetes

Lyumjev, Lilly’s recently-approved rapid-acting mealtime insulin, may be more effective for managing glucose levels than Humalog (another mealtime insulin from Lilly) in people with type 1 diabetes who use insulin pumps. New data from a 16-week study compared Lyumjev to Humalog in 432 people (all with type 1 diabetes and using insulin pumps) and found:

• Lyumjev significantly reduced post-meal glucose levels one hour and two hours after eating, compared to Humalog. (One-hour difference: -24 mg/dl; two-hour difference: -28 mg/dl).

• People taking Lyumjev spent significantly less time in hypoglycemia (glucose below 70 mg/dl): 85 minutes per day, compared to 106 minutes per day with Humalog.

• The effect on A1C level and time in range (TIR) of the two insulins was not significantly different. There were also no significant differences between the two insulins for severe hypoglycemia and DKA. This means that the two insulins are similarly effective and safe.

This data supports the use of Lyumjev, especially for people on pump therapy. Lyumjev is currently approved for injection and pump therapy in Europe, Japan, and Brazil, while in the US it is still only approved for injection. This latest trial data may help gain approval for Lyumjev with insulin pumps in the US.

INNODIA research initiative standardizes type 1 diabetes research in Europe

The goal of the INNODIA project – a global partnership among 31 academic institutions, 6 industrial partners, a small company, and 2 patient organizations – is to improve treatments for type 1 diabetes. Based in Europe, INNODIA focuses primarily on improving research in the field through five main objectives:

• Establish clinical infrastructure in Europe to identify and collect samples from newly diagnosed people with type 1 diabetes and at-risk individuals through screening of unaffected family members (UFM)

• Create a collaborative research network between all partners and institutions

• Support the research and development of new treatments for type 1 diabetes

• Create a large research database

• Standardize clinical trials studying type 1 diabetes

The project has created a standard method (called a Master Protocol) of studying type 1 diabetes in clinical trials across Europe. Under the INNODIA Master Protocol, people with type 1 diabetes should be identified and enrolled in the trials within six weeks after diagnosis; over the next two years researchers collect samples (including A1C and dried blood spot samples – unique to INNODIA) at specific time points, with standardized results uploaded to a central database.

Using this Master Protocol, four trials are scheduled to begin this fall and be complete by 2022: MELD-ATG, IMPACT, Ver-A-T1D, Iscalimab (CFZ533). All are investigating various therapies for people with type 1 diabetes. We look forward to the research coming from the INNODIA partnership – we will keep you updated as trials begin recruiting and as results are published.

Big Picture: Time in Range and COVID-19

Landmark data: more time in range is associated with fewer microvascular complications

Dr. Anass El Malahi presented  data on the relationship between time in range (TIR) and diabetes-related health complications. Using data from Belgium’s RESCUE trial (which included 515 adults with type 1 diabetes using insulin pumps), Dr. El Malahi explained the strong correlation between time in range and several microvascular diabetes complications:

• Higher time in range was significantly associated with less microvascular complications. Half of the participants with TIR below 40% had at least one microvascular complication; in contrast, just 27% of people with TIR greater than 70% had at least one microvascular complication.

• Retinopathy (a type of eye disease) was also strongly correlated with TIR. The rates of retinopathy for people with TIR below 40% were double the rates of retinopathy in people with TIR above 70%.

• Higher time in range was also linked to fewer diabetes-related hospitalizations. Among participants who were not hospitalized for hypoglycemia or diabetic ketoacidosis (DKA) in the prior twelve months, the average TIR was 64%. For people who had been hospitalized in the prior year, average TIR was 59%.

Importantly, the associations between TIR and complications did not depend on how long someone had diabetes.

Time in range linked to heart health and severe hypoglycemia

Dr. Rich Bergenstal presented results from an analysis of the DEVOTE clinical trial provided even more evidence for using time in range (TIR) as a main metric of diabetes management. The trial data included 5,774 people with type 2 diabetes who had at least six self-monitored blood glucose (SMBG) measurements – these glucose profiles were used to calculate a “derived TIR” used in place of an actual TIR measurement that would come from continuous glucose monitor (CGM). The analysis found that higher derived TIR was linked to fewer major adverse cardiovascular (MACE, or heart-related) and severe hypoglycemia events:

• Every 10% increase in TIR was associated with a 6% relative risk reduction for MACE (defined as non-fatal heart attack, non-fatal stroke, and cardiovascular death). Compared to people with a TIR below 50%, a TIR between 50%-70% was associated with a 9% relative risk reduction for MACE, and a TIR above 70% was associated with a 31% relative risk reduction.

• Every 10% increase in TIR was associated with a 10% reduction in risk of severe hypoglycemia events. Compared to people with TIR below 50%, a derived TIR between 50%-70% was associated with a relative risk reduction of 13% for severe hypoglycemia, and a TIR above 70% was associated with a 46% relative risk reduction. (Dr. Bergenstal noted that these data show that “tighter” glucose management or higher TIR does not necessarily lead to more hypoglycemia.)

• TIR was also associated with microvascular complications. Compared to people with derived TIR below 50%, a derived TIR between 50%-70% was associated with a relative risk reduction of 27% for microvascular complications, and a derived TIR above 70% was associated with a 40% relative risk reduction.

Many people with diabetes and their healthcare teams use TIR as a measure of diabetes management to accompany A1C tests. TIR is a powerful tool for people with diabetes to assess patterns in blood glucose levels throughout the day, which helps inform daily treatment decisions. However, while research has shown a direct relationship between A1C level and diabetes-related complications, until now that direct line has not been drawn for TIR. This data will support greater acceptance and integration of TIR in diabetes care, making a huge difference in the day-to-day and long-term experiences of people with diabetes.

COVID-19 and diabetes: what we know for people with type 1 and type 2 diabetes

Panelists discussed the intersection between COVID-19 and diabetes. Dr. Juliana Chan shared data from England showing that people with diabetes had higher chances of COVID-19-related death in the hospital compared to people without diabetes: the rate was three times higher for people with type 1 diabetes and two times higher for people with type 2 diabetes. The study found that several factors increased the risk of COVID-19-related death in people with diabetes:

• Higher A1C levels (above 10% for people with type 1 diabetes and above 7.5% for people with type 2 diabetes)

• Lower kidney function (eGFR below 59 ml/min/1.73 m²)

• Having an excessively high or low body weight

However, researchers agree that while diabetes increases the risk of death due to COVID-19, it does not increase someone’s risk of being infected with COVID-19.

For people with type 2 diabetes, Dr. Daniel Drucker argued that reducing glucose is the most powerful tool for protecting against COVID-19 complications. Many risk factors for COVID-19 mortality, like decreased kidney function and being overweight, are hard to change quickly; however, intense glucose management can be achieved . Dr. Drucker said, “We can do a lot to prevent the development of COVID-19, and this needs to be emphasized over and over again to people with diabetes.”  However, it is important to remind people  that glucose control is a critical risk factor if infection occurs.

Here are Dr. Drucker’s recommendations for people with diabetes during the COVID-19 pandemic:

• Prevention: Keep physical distance from others, practice personal hygiene and wash your hands, and wear a face mask

• Prepare a list of your medications (both written and stored on a smartphone)

• Make sure you have enough diabetes supplies, including medications, test strips, and CGMs

• Don’t forget about or neglect exercise, diet, blood glucose, and blood pressure management

• Use telemedicine and devices to communicate with your healthcare team

• Stay hydrated and monitor your glucose and ketone levels

• Optimize your glucose levels and stay in-range whenever possible

• If hospitalized, clearly communicate your diabetes medications to your healthcare professionals

Dr. Catarina Limbert discussed the lessons learned about COVID-19 in relation to people with type 1 diabetes:

• The surge in telemedicine has shown that hybrid models of in-person and virtual care clinics are important for meeting the needs of people with diabetes.

• While the data shows that people with type 1 diabetes have a higher risk of COVID-19-related death, this risk applies mostly to a limited population: people over the age of 50, who have had diabetes for more than 20 years, and who have an A1C above 10%.

• COVID-19 does not appear to trigger more new-onset type 1 diabetes. Data from Germany and Italy show that rates of new-onset type 1 diabetes have remained stable or decreased during the pandemic.

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