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Highlights from EASD 2021

Published: 10/1/21
24 readers recommend
By: Matthew Garza Andrew Briskin Arvind Sommi Julia Kenney Natalie Sainz

diaTribe is excited to bring you additional expanded coverage from the EASD 2021 virtual conference this past week! Find out more from leading clinicians and researchers around the world on insights into the latest data on automated insulin delivery, diet and nutrition, SGLT-2s, GLP-1s, and chronic kidney disease.

Check out our special edition, EASD 2021 conference coverage below, and keep an eye out as we bring you more on the latest innovations in diabetes technology, therapies, and management. From automated insulin delivery (AID) systems to SGLT-2 inhibitors to the dangers of hypoglycemia, check out the latest data below.

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New ADA/EASD Consensus Report on Type 1 Diabetes Care

The American Diabetes Association (ADA) and EASD joined forces to publish a new consensus report on diabetes care for adults with type 1. Both organizations believed that current care guidelines for type 1 diabetes were too broad and difficult to apply to individuals’ health needs. To address this, the report highlights the main areas that healthcare providers should consider when caring for adults with type 1 diabetes. Notable T1D management priorities outlined in the report include:

  • DiagnosisNear 40% of people diagnosed with type 1 over the age of 30 are first misdiagnosed. The report calls for more specific diagnosis guidelines and provides an algorithm for healthcare providers to refer to in diagnosing type 1 diabetes.

  • Glucose MonitoringThe report strongly recommends the use of CGM to monitor blood glucose in adults with type 1 diabetes. While BGM can be used as a back-up option, CGM metrics such as Time in Range (TIR) can help people with diabetes and providers access real-time health data to inform daily diabetes management and avoid dangerous health complications.

  • Insulin therapyInsulin analogues are described as the “treatment of choice” for adults with type 1 diabetes because they act faster and help them avoid lows and post-meal highs. The report recommends the use of multiple daily injections (MDI) or pump therapy and notes that CGM use can support insulin therapy in adults with type 1.

  • Psychosocial careDiabetes health is impacted by a series of social factors and providers must account for these when caring for someone with type 1 diabetes. The consensus report does not provide specific guidelines for when psychosocial care should be incorporated but does state that “self-management difficulties, psychological, and social problems should be screened periodically and monitored.”

  • Type 1 curesPancreas and islet cell transplantation are beta-cell replacement therapies that could act as functional cures to type 1 diabetes. These therapies do require lifelong immunosuppression and the report urges people with diabetes and their providers to understand the risks and benefits associated with both procedures.

The consensus report has additional sections on addressing diabetes self-management education (DSMES), hypoglycemia, diabetic ketoacidosis (DKA), adjunctive therapies, and T1D management in pregnant women and high-risk populations. By providing clearer, more specific T1D care guidelines, this report can foster more individualized and person-centered healthcare for adults with type 1.

People with Type 1 Diabetes Could Benefit From SGLT-2s and GLP-1s 

Though the Food and Drug Administration (FDA) has not approved the use of either SGLT-2 inhibitors or GLP-1 receptor agonists for people with type 1 diabetes, researchers are gathering data to determine whether the benefits could outweigh potential risks.

The following three cohorts, summarized below, presented at the EASD 2021 conference included people with type 1 diabetes who used either an SGLT-2 inhibitor or GLP-1 receptor agonist. Results from the studies on these cohorts showed that liraglutide (a GLP-1 medication) was found to improve (depending on the size of the dose) glucose management, reduce body weight, and lead to reduced insulin needs when compared with a placebo.

Dapagliflozin (an SGLT-2) led to increases in TIR without any significant increase in hypoglycemia occurrences. And finally research out of Belgium showed that the use of SGLT-2s led to lower A1C, reduced weight, and reduced total insulin dose, but still resulted in a small number of diabetic ketoacidosis cases. 

“I think certainly the use of SGLT2 inhibitors in people with type 1 diabetes should be considered as our data shows the importance of good patient selection,” said Falco van Nes, from UZ Gasthuisberg, in Leuven, Belgium. “Those who use insulin pumps or are at a low BMI you really have to be careful with it. It certainly has its place in type 1 diabetes but you really have to educate your patients very well and watch out for the side effects.”

Cohort

Results

In a broad population of 2233 people with type 1 treated with liraglutide (1.8 mg) or a placebo added to insulin for 26 weeks results showed that liraglutide:

  • A1C was reduced by 0.8 percentage points

  • Total daily insulin dose was reduced by 14%

  • Body weight was reduced by 5kg

  • Rates of hyperglycemia with ketosis and rates of hypoglycemia was not clinically significant 

In 60 people with type 1 diabetes on basal insulin and dapagliflozin that were either instructed (Group A) or not instructed (Group B) to reduce their total insulin dose by 10% by reducing basal insulin dose only, results showed that:

  • Group A’s hypoglycemia frequency in times/day wentr from 0.232 to 0.269

  • Group A’s Time in range (TIR) went from 63.6% to 69.7%

  • Group B’s hypoglycemia frequency in times/day went from 0.197 to 0.233

  • Group B’s TIR went from 59% to 69.1%

  • Use of dapagliflozin resulted in greater TIR 

In a retrospective study of 199 patient records looking at results after 1 year of SGLT-2 use in adults with type 1 diabetes, results showed that:

  • Those with BMI greater than or equal to 27 kg/m3 had their A1C drop from 8.3% to 7.7%

  • Those with BMI greater than or equal to 27 had their weight drop from 89.4 kg to 85.9 kg

  • Those with BMI greater than or equal to 27 had their total daily insulin dose drop from 0.689 U/kg to 0.619 U/kg

  • Those with BMI less than 27 had A1C drop from 8.1% to 7.8%

  • Those with BMI less than 27 had their weight drop from 71.1 kg to 69.4 kg

  • Those with BMI less than 27 had their total daily insulin dose drop from 0.623 U/kg to 0.674 U/kg

  • 29% of participants reported adverse events with the majority being genital infections most prevalent in women but independent of BMI or the dose of SGLT-2

  • There were 7 instances of DKA among the 199 patients

Chronic Kidney Disease: A Patient Perspective on the Importance of Early Diagnosis

Chronic kidney disease (CKD) is one of the most common diabetes-related complications, affecting approximately one in three adults with diabetes. CKD can be life threatening if left untreated but thankfully, new pharmaceuticals, such as SGLT-2 inhibitors, and lifestyle intervention can slow the progression of the disease and improve overall kidney health. However, these interventions have proven to be far more effective if introduced as early as possible, leaving many people frustrated and frightened by a diagnosis of CKD at a more advanced stage.

People with diabetes at risk for CKD should be empowered to voice their concerns to their healthcare provider and ask for screening. One man from South Wales, U.K., John, who didn’t reveal his last name, shared his experience at the EASD 2021 conference of being diagnosed with CKD and why he wished his healthcare team had given him more information earlier.

“I was diagnosed with stage 4 CKD in December 2018,” John said. “I finally got a copy of my medical records in 2019, which said I was diagnosed with kidney disease stage 3A in 2007. Nobody had ever told me anything in 11 years other than ‘We’ll keep a close eye on your kidneys.’”

John urged healthcare providers, “When you talk to your patients, be honest about CKD, but keep it positive. And if you have some information [that could help them treat the disease early], don’t keep it to yourself for 11 years.”

John said that people like himself can benefit from early diagnosis and guidance from their healthcare providers, but many are not receiving it. “I would have wanted to hear about a recommended dietician, or help with any number of factors that could slow the disease progression,” he said. “I would have made changes to my diet, and possibly other things as well, if I had simply known what to do.”

If you may be at risk for developing CKD, talk with your healthcare provider about getting screened and how to best intervene early on. If you are not already taking one, consider asking your provider about SGLT-2 inhibitors or blood pressure medications and how they can support kidney health. For providers and people with diabetes, it is important to remember the acronym CKD:

  • Check kidney numbers

  • Kick off a conversation

  • Diagnose Early

For more information about CKD, the importance of early diagnosis, and supporting healthy kidney function, check out this overview.

MiniMed 780G System Leads to Improvements in Glucose Levels and Time in Range

The MiniMed 780G is Medtronic’s second-generation automated insulin delivery system (an upgrade from the 670G system). The device, available in Europe but still under FDA review in the US, includes automatic basal rate adjustments and correction boluses, an adjustable glucose target down to 100 mg/dl, fewer alarms, and simpler operation with the goal of further increasing Time in Range (TIR).

Real world data of the 780G in Europe shows improvements in TIR and glucose management indicator (GMI) (which can be thought of as an estimated A1C), said Prof Ohad Cohen, Medtronic’s director of Medical Affairs.

“Even with the growing number of users, more countries using it, more physicians using it, we see that these results are stable,” he said. “And when you look at six months of follow up [these results] are also sustainable, and actually there is almost no change in both the TIR and the GMI [from initiation to month six].”

The following three cohorts included 780G users across Europe who uploaded their data to CareLink between August 2020 and July 2021 and who gave permission for their data to be studied.

Cohort

Results

Users with more than 10 days of data after initiating the MiniMed 780G (12,870 users)

  • 76% of users achieved a GMI less than 7%

  • 76% of users achieved a TIR greater than 70%

  • 82% of users achieved a Time Below Range (TBR) (less than 70 mg/dL) of less than 4%

  • 58% of users achieved all three of these metrics

Users with more than 10 days of data both when they were on the MiniMed 780G in “open-loop” and after using it in advanced hybrid closed-loop (2,977 users)

  • 75% of users achieved a GMI less than 7% when in closed loop (only 41% achieved this in open loop)

  • 75% of users achieved a TIR greater than 70% when in closed loop (only 36% achieved this in open loop)

  • The average sensor glucose readings decreased by 15 m/dL from 161 mg/dL in open loop to 146 mg/dL

  • Average GMI decreased by 0.4 percentage points from 7.2% in open loop to 6.8%

  • Average TIR increased by 11.4 percentage points from 64% in open loop to 76%

  • Average TBR decreased by 0.5 percentage points from 3.3% in open loop to 2.8%

Users with more than 10 days of data in each of the first six months after initiating the MiniMed 780G (2,566 users)

  • At one month, users mean sensor glucose was 143 mg/dL, GMI was 6.7%, TIR was 77% and TBR was 3%

  • These positive metrics were sustained out to six months – users mean sensor glucose was 144 mg/dL, GMI was 6.8%, TIR was 76% and TBR was 2.9%

Promising results from people using both Steglatro and insulin with type 2 diabetes and cardiovascular disease

“We all know that type 2 diabetes is a very complex disease, with a very complex pathophysiology,” said Dr. Ildiko Lingvay of UT Southwestern. The best way to treat this disease “is to combine agents with multiple mechanisms of action” and therefore “improve the efficacy of the treatment,” she said. 

SGLT-2 inhibitors, a type of glucose-lowering medication with far reaching benefits, can help with treating all of the complex effects of type 2 diabetes. “We can use it in combination with insulin to garner the benefits of both of these classes [of medication] in controlling blood sugar and additional benefits,” said Dr. Lingvay.

The VERTIS-CV trial is a well-known study that evaluated the effects of Steglatro (ertugliflozin) on over 8,000 people with type 2 diabetes and cardiovascular disease (CVD). The trial found that treatment with Steglatro reduced participants’ average A1C by 0.5 percentage points, lowered average weight by nearly five pounds, and reduced blood pressure compared to standard diabetes treatment. Steglatro also improved kidney function (as measured by eGFR) and reduced the number of study participants with heart failure. You can learn more about VERTIS-CV here

In a sub-study, called VERTIS-CV INSULIN, results showed that Steglatro, when added to insulin, significantly reduced A1C, body weight, and systolic blood pressure in patients with diabetes and cardiovascular disease. This study, which lasted 18 weeks, enrolled people over age 40 with type 2 and cardiovascular disease on insulin (with or without metformin), but who still had poor glucose management. Over 1,000 people were included and were randomly assigned to either oral, once-daily Steglatro (5mg or 15mg) or the placebo (a non-therapy pill). 

At both doses, Steglatro demonstrated about a 0.6 percentage point reduction in A1C over 18 weeks compared to people who did not receive the SGLT-2. For people who were assigned to the 5 mg dose, A1C was significantly reduced by 0.58 percentage points and for people who received the 15 mg dose, A1C reduced by 0.65 percentage points.

Additionally, Steglatro produced significant reductions in participants’ fasting glucose, body weight, and blood pressure as seen in the graphs.

These results suggest Steglatro and SGLT-2 inhibitors in general may be useful in treating people with type 2 diabetes on insulin who need additional help in managing their glucose levels. According to Dr. Lingvay, “This should impact the way we treat patients with type 2 diabetes and [cardiovascular disease].”

SGLT-2 Inhibitors Safe and Effective in Older People with Type 2 Diabetes

SGLT-2 inhibitors are a type of glucose-lowering medication for people with type 2 diabetes that have been shown to have impressive effects. They also help people with other diabetes-related health conditions, such as heart disease, heart failure, and kidney disease.

Type 2 diabetes is more prevalent in people older than 65 compared to younger populations (almost one in four people 65 and older have diabetes), and recent studies have provided evidence that SGLT-2 inhibitors may be a promising therapy for these people.

“The aging process is strongly associated with the development of diabetes,” Maria Lunati from the University of Milan. Elderly individuals also often have multiple comorbidities (or other medical conditions) and are at higher risk for cardiovascular (heart) and kidney complications.

Considering the increased risk for complications and the beneficial potential of SGLT-2 inhibitors, effects of these therapies have been studied in older people with type 2 diabetes. Overall, the results showed that “SGLT-2 inhibitors appear to be a valid therapeutic option in elderly populations,” Dr. Lunati said.  

In one study, treatment with an SGLT-2 inhibitor provided a significant decline in glucose values and a 0.3 percentage point reduction in A1C after a one year follow-up. Additionally, eGFR values (a measure for how well your kidney is functioning) remained stable over time, highlighting the well-tolerated nature of the therapy.

Another study further explored the benefits of Steglatro, a common SGLT-2 inhibitor. This VERTIS-CV trial studied the effects of Steglatro in over 8,000 people with type 2 diabetes and cardiovascular disease (CVD). The trial found that treatment with ertugliflozin reduced participants’ A1C by an average of 0.5 percentage points, lowered their average weight by nearly five pounds, and reduced blood pressure compared to standard diabetes treatment. Ertugliflozin also improved kidney function (as measured by eGFR) and reduced the number of study participants with heart failure. You can learn more about the VERTIS-CV trial results here.

Dr. Richard Pratley, medical director at AdventHealth Diabetes Institute, took a more focused approach to the VERTIS-CV study analysis and presented on the effectiveness of ertugliflozin, specifically in elderly individuals. “Our objective in this analysis was to assess selected cardiovascular and kidney outcomes and the safety [of Steglatro] in older patients with type 2 diabetes and atherosclerotic cardiovascular disease in the VERTIS CV,” he said.

The results showed that “the effects of ertugliflozin on cardiovascular and kidney outcomes did not differ by treatment assignment between the subgroups of patients above 65 and below 65 years or in the subgroups of patients above 75 and below 75 years,” Dr. Pratley said.

Simply put, the results in the older population were consistent with the results from the overall original cohort from the VERTIS-CV study (regardless of age). This indicates that Steglatro can be assumed to be generally well tolerated in older populations patients with no specific safety concerns for this group.

The Health Consequences of Frequent Hypoglycemia

In the short term, having low glucose levels (hypoglycemia) can make you feel tired, foggy, and make it difficult to accomplish daily tasks. Research has found that there are serious long term health consequences of frequent low blood sugar levels.

One exciting development in hypoglycemia research has been the preliminary results from the Hypo-RESOLVE Study – a project developed by JDRF and Novo Nordisk to better understand the impact of hypoglycemia and its relationship to diabetes complications. The study analyzed cases of hypoglycemic events in over 22,000 people with type 1 and type 2 diabetes and outlined set hypoglycemia categories:

  • Level 1: 54 mg/dl – 70 mg/dL

  • Level 2: Less than 54 mg/dL

  • Level 3: Also referred to as severe hypoglycemia, this is any case of low glucose that requires emergency assistance from someone else.

Dr. Joseph O’Reilly from the University of Edinburgh, Scotland, shared some of the preliminary results from the Hypo-RESOLVE study:

  • There is an association between the number of hypoglycemic events in the past 45 days and the risk for another hypoglycemic event (of any level) in the following 45 days.

    • This was seen in both people with type 1 and type 2 diabetes, the more events you had previously, the greater your risk for another event.

  • Frequent low glucose levels were associated with an increased risk of nerve disease (neuropathy) and heart disease in participants with type 2 diabetes. The data indicated that there may be a relationship between hypoglycemia and health complications in people with type 1 diabetes, but those results were not significant.

While low blood sugar can be difficult to avoid completely, these results indicate that reducing all levels of hypoglycemia can help decrease your risk for serious health complications. Given that hypoglycemic events are associated with subsequent severe hypoglycemia, which in turn is associated with further complications like nerve damage or heart disease, Dr. O’Reilly said that these preliminary results suggest that a snowball effect may be initiated by experience any degree of hypoglycemia.

To learn more about hypoglycemia and how to identify the warning signs, read “Detecting the Signs: Hyperglycemia vs. Hypoglycemia.

Real-Time Continuous Glucose Monitoring for All People on Insulin: The Emerging Standard of Care

Using a continuous glucose monitor (CGM) to assist with diabetes management can have very positive effects on both a person’s physical and mental health. One CGM, the Dexcom G6, has been shown to have impressive impacts on diabetes management. In recent years, researchers have been particularly interested in the benefits of real-time CGM (rtCGM, which continuously reports glucose data and alerts users about high or low glucose levels) over intermittently-scanned CGM (isCGM, which reports values only when manually scanned by the user using a separate device).

One study published in JAMA showed that people with type 1 diabetes using the Dexcom G6 experienced significant improvements over those using self-monitoring blood glucose (SMBG), including:

  • Their average A1C was reduced by 0.43 percentage points (from 8.35% during the SMBG treatment to 7.92% during CGM treatment)

  • Less hypoglycemia, or glucose levels below 70 mg/dL (3.58% during the CGM treatment versus 6.68% during SMBG treatment)

  • Improved quality of life

  • They were more likely to continue using their treatment compared to those only using SMBG

 A similar study released in 2020 demonstrated that after 6 months of using the Dexcom G6, people with type 1 had:

  • A significantly lower A1C than those using SMBG (7.7% versus 7.0%)

  • Increased Time in Range by 7.4 percentage points (about 1 hour and 45 minutes each day)

  • Reduced Times Above and Below Range

These results were observed regardless of whether participants received multiple daily injections (MDI) of insulin or used an insulin pump. When the group using CGM was switched to SMBG and vice versa, the group now using CGM experienced an identical result to the original group, suggesting that the use of CGM is more important toward maintaining glucose management than the method of insulin delivery.

To better understand the advantages of rtCGM over isCGM, researchers conducted the ALERTT1 trial. In this trial 254 individuals with type 1 diabetes were assigned to either rtCGM or isCGM. Those using rtCGM spent significantly more Time in Range than those who were on isCGM after six months, a difference of 1 hour and 39 minutes per day. In addition, people using rtCGM reported being much happier with their treatment and less worried about hypoglycemia than those on isCGM.

“I believe that alerts and alarms are key in ensuring these improvements in Time in Range,” said Dr. Pieter Gilliard, an investigator on the ALERTT1 trial.  “If someone already has good control of their glucose levels, we would not want to force a change, but it is worth considering a switch from isCGM to rtCGM for those who may struggle with glucose control.” Dr. Gilliard mentioned his vision for a three-year extension to this study, which will investigate the cost-effectiveness and long-term effects of switching to rtCGM.

Debates on Nutrition: Low-Carb or Low-Fat?

The sheer volume of information on ways to tackle diet and nutrition for people with diabetes can be overwhelming. Some recommendations focus on low-fat diets while others encourage limiting carbohydrates – and each person’s body responds differently to different eating plans.

Dr. Stefan Kabisch from Charité – Universitätsmedizin Berlin presented on how low-carb and low-fat diets have the potential to prevent diabetes in both men and women. The DiNA-P study included 267 people with high-risk prediabetes who were randomly assigned to either a low-fat or low-carb diet for one year.

Results showed:

  • Women experienced greater short-term (effects at three weeks) health benefits from the low-carb diet which helped reduce

  • Fasting glucose by an average of 10.8 mg/dL from baseline

  • Systolic and diastolic blood pressure by an average of 11 mmHg and 6 mmHg respectively from baseline

  • Cholesterol (measured by the ratio of low-density lipoprotein to high density lipoprotein) by an average of 0.3 from baseline

  • Triglycerides by an average of 57 mg/dL from baseline

  • Men experienced greater short-term (effects at three weeks) benefits from the low-fat diet which helped reduce

  • C-reactive protein levels by an average of 0.8 mg/L from baseline

  • Uric acid by an average of 0.6 mg/dL from baseline

  • 2-hour post-meal glucose by an average of 21.4 mg/dL from baseline

  • At one year, both men and women show a greater compliance to a low-carb diet than a low-fat diet, but the differences between the two diets on other metrics were not significant.

While low-carb diets can be beneficial for diabetes prevention, they can also improve health outcomes in people with diabetes, said Dr. Nicole Jacqeline Jensen with the University of Copenhagen. She further explained that low-carb diets can also have an impact on cognitive performance and health-related quality of life outcomes in people with type 2 diabetes. She presented a study of people with type 2 diabetes and obesity who were randomly assigned to either a low-carb, high-protein diet or a conventional diabetes diet that was not specifically low-carb. The results showed:

  • The low-carb and conventional diabetes diets both led to similar physical health-related quality of life outcomes (physical functioning, health perception, bodily pain, and role functioning), and there were not significant differences in most aspects of cognitive performance (such as verbal memory).

  • The low-carb diet did show improvements in participants’ mental health outcomes, but the results were not significant.

Carbohydrate restriction, often encouraged for helping people with diabetes manage their glucose levels, may influence mental health and some cognitive tasks; however, these effects appear modest. But the overall data suggests that this is a safe dietary strategy for people with diabetes, Dr. Jacqeline Jensen said.

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