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Category Archives: Diabetes

Supercut of Wilford Brimley saying "Diabeetus" contrasted against other people saying "Diabetes" – Boing Boing

Posted: October 11, 2019 at 3:44 pm

Behold the master in enunciation outclass the mediocrities that surround him.

Previously in Diabeetus: Cat resembling Wilford Brimley skilled in art of playing "death by diabeetus"

Gil Gerard, star of the fantastic Buck Rogers in the 25th Century has joined 2491 as an actor and producer. 2491 was inspired by the fantastic Buck Rogers series. Hollywood Reporter: Former Buck Rogers in the 25th Century star Gil Gerard has come aboard a sci-fi project that wants to recapture the spirit of the []

Seems a pro-poker player, Mike Postle, has achieved impossible-seeming results. Other players have put hours upon hours upon hours into analyzing his baffling play. It is like watching someone play with perfect information, they claim! While nothing definitive has been found, Stones Gambling Hall, a live poker site where the questionable Postle has spent a []

Uhh whats it like? pic.twitter.com/7G2jiwdMvO Silvia Killingsworth (@silviakillings) September 25, 2019 Shaking the champagne bottle.

No matter what kind of office you work at, theres probably an Excel expert in it. And no wonder: Businesses are still discovering uses for one of Microsofts flagship software suites beyond just bare-bones spreadsheets. Make October the month you become invaluable at work by taking one of these boot camps in Excel and its []

Whoever said youd never need math to succeed in life clearly never sat down at a high-stakes poker table. When it comes right down to it, poker is a winnable game no matter where you play it as long as you play the odds. There are time-honored strategies for playing those odds, tested by []

Clearly theres a booming market for CBD out there, as more people discover the relief from pain and stress that it can bring. But not everyone uses it the same way, and thats why cannabidiol products from Common Ground are gaining ground with consumers not just because theyre one of the most trusted sources []

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Supercut of Wilford Brimley saying "Diabeetus" contrasted against other people saying "Diabetes" - Boing Boing

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Moore resident says diabetes, nutrition program improved quality of life – Sandhill Sentinel

Posted: October 11, 2019 at 3:44 pm

For more than 20 years, Cynthia Brewer had been able to manage her diabetes largely on her own. If her blood glucose levels became elevated, Brewer would adjust her daily diet based on what had always worked for her.

If I knew I was going out to supper and have a baked potato, I would watch what I ate all day and could manage it that way, says Brewer, who lives in northern Moore County.

But when those efforts recently stopped working, Brewer decided to completely cut out foods such as potato chips and crackers, believing that would control her glucose levels.

Even though I was watching what I ate even more carefully, and had eliminated certain things from my diet, my sugar levels were still high.

Simultaneously, Brewer realized she did not feel well many days and was becoming discouraged about suddenly being unable to control her diabetes as she always had.

That all changed recently when Brewers physician referred her to FirstHealths Diabetes and Nutrition Education Center. Working with certified diabetes educator and registered dietitian Michelle Cole, who directs the program, Brewer has adopted new strategies to manage her diabetes.

One of the fundamental changes has been her daily approach to eating, Brewer says.

Mostly, Ive learned to watch what I eat, and compensate for things Ive cut out with other foods, Brewer says. Shes also learned that she doesnt have to completely eliminate the foods she likes, something she had done before joining the program. Ive really cut down on things like breadIll cut an English muffin in half each morning and eat that with egg and a little bacon. Then for lunch or dinner, I might fix a hamburger and toast the other half of the English muffin and have it with my burger.

Cole says education is a key component of the program, especially when it comes to diet.

It is very common for our patients to make comments such as, I cant believe I can actually eat this much food or, I was told I cant eat anything white, but now I see that I can. Many people believe that once you are diagnosed with diabetes, you must then deprive yourself of foods and ingredients, or limit your intake of food in general.

Instead, Cole says she and her staff of diabetes educators and dietitians tell patients that no foods are off-limits but provide them with information on how certain foods affect the body and which ones are better for overall health.

Patients meet with one of the staff dietitians and receive an individualized meal plan, as well as tips for new recipes and making wise choices while grocery shopping.

A healthy diet is just one component of diabetes management, and Cole emphasizes the program works with patients on other areas that are critical to their health.

We help patients with an overall approach to exercise, monitoring glucose levels, taking medication, problem solving, reducing risks, and healthy coping, Cole says.

In addition to her dietary changes, Brewers diabetes management plan now includes insulin. She admits she was reluctant at first, but other diabetes medications werent an option for her.

Cole explained how insulin works in the body, and that sometimes diet and exercise alone arent enough for some patients to manage their condition.

After that discussion, Cole followed up with Brewers physician to recommend an insulin prescription. I felt very confident that Michelle had my best interests at heart, so I felt good about it.

FirstHealths program offers individualized and group sessions, depending on each patients needs.

We often hear feedback from our patients that having someone listen to them and spend time with them, whether in a one-on-one session or group, helps alleviate anxiety surrounding their health conditions, Cole says. Many patients particularly enjoy the group setting, meeting others and learning from their experiences of dealing with the same day-to-day obstacles they do.

Cole and her staff work hard to inform patients and dispel the myths that sometimes surround diabetes management.

In todays society, there is a magnitude of information available, Cole says. Sometimes its difficult to decipher between truth and misleading information, or even harmful information. Our program provides evidence-based information, which is derived from national standards of care.

For Brewer, the program has vastly improved the quality of her life.

I feel the best I have in a long time, Brewer says. She is quick to credit Cole, her staff and the program for giving her a new outlook on life with diabetes. Its not that you have to go through life saying I cant have this, I cant have that. You just have to have common sense about it.

Courtesy photo: certified diabetes educator and registered dietitian Michelle Cole (L) and patient Cynthia Brewer.

Contributed

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Moore resident says diabetes, nutrition program improved quality of life - Sandhill Sentinel

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Multiple Perspectives on Nation’s Insulin Crisis Reported in Special Issue of Evidence-Based Diabetes Management – Business Wire

Posted: October 11, 2019 at 3:44 pm

CRANBURY, N.J.--(BUSINESS WIRE)--Theres no shortage of ideas and policy proposals to lower the cost of prescription drug prices, particularly insulin, which people with type 1 diabetes (T1D) need in order to stay alive. But while conversation and debate about insulin pricing continue to drag on without a resolution, patients suffer, sometimes with deadly consequences. In the September special issue of Evidence-Based Diabetes Management (EBDM), called Perspectives on Insulin Pricing, young adults speak about the effect the disease has had on their health and finances, the head of JDRF discusses legislative reform, the editor-in-chief describes the consequences of rationing and researchers outline improved adherence and cost savings by switching from analogue insulin to human insulin.

Articles featured in the issue include:

Young adults defer career dreams and scramble for steady health benefits. Young adults are grateful for the Affordable Care Act (ACA), which allowed them to stay on their parents health plan until age 26, but they tell of struggling under the weight of high-deductible health plans and high cost sharing, if they can obtain a position with benefits at all. Some worry about what will happen if the ACA is overturned and, with it, protections for people with preexisting conditions like diabetes.

Teenage recalcitrance over a diabetes diagnosis leads to adult complications. A college graduate describes the common circumstance of teenagers struggling to become responsible for a life-threatening illness, which in her case caused temporary vision loss and a rare gastrointestinal illness that led to unemployment.

We may not know the total cost of todays insulin crisis until tomorrow. Robert A. Gabbay, MD, PhD, FACP, the editor-in-chief of EBDM, says the consequences of rationing, such as more time in hyperglycemia or greater risk of diabetic ketoacidosis, increase the likelihood of future complications such as blindness and kidney failure. The total costs of diabetes complications borne by health systems triggered by todays high insulin prices may not be fully known for years.

Action is needed by Congress, insulin makers, health plans and the federal executive branch. Aaron Kowalski, PhD, the first chief executive officer of JDRF, who has T1D himself, discusses his support for a new bill that would ban rebates on insulin formations that sell above their 2006 prices.

Its possible to improve adherence and lower costs by switching insulin. The high cost of analogue insulin hurts patients by limiting affordability, worsening medication adherence and leading to microvascular and macrovascular complications, say CareMore Health researchers. The authors write about the experience of switching Medicare Advantage patients to a new regimen of human insulin, with less frequent injections and a delay in reaching the so-called donut hole, or coverage gap, in Medicare Part D.

Find these and other articles in EBDMs Perspectives on Insulin Pricing issue here.

AboutThe American Journal of Managed Care

The American Journal of Managed Care(AJMC) is a multimedia peer-reviewed, MEDLINE-indexed journal that keeps industry leaders on the forefront of health policy by sharing digital research relevant to industry decision-makers. Other brands in theAJMCfamily includeThe American Journal of Accountable Care,Evidence-Based Oncology andEvidence-Based Diabetes Management. These comprehensive multimedia brands bring together stakeholder views from payers, providers, policymakers and other industry leaders in managed care. AJMC is a brand of MJH Life Sciences, the largest privately held, independent, full-service medical media company in the U.S. dedicated to delivering trusted health care news across multiple channels.

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Multiple Perspectives on Nation's Insulin Crisis Reported in Special Issue of Evidence-Based Diabetes Management - Business Wire

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Incidence of Type 2 Diabetes Up in Younger People and Risks Greater – Medscape

Posted: September 19, 2019 at 9:52 am

BARCELONA - The proportion of younger adults (18-40 years) diagnosed with type 2 diabetes has risen from 9.5% to 12.5% since the year 2000, with younger diabetics having higher cardiovascular (CV) risk factors compared with older people with the disease, finds a study of UK primary care data.

Type 2 diabetes incidence in people aged 41-50 years also increased from 14% to 17.5% over the 17 years of the study that began in 2000. CV morbidity and all cause mortality rates remained stable in younger age groups after 2005, even while mortality rates declined substantially among patients aged over 60.

Effectively, in the UK today, around 1 in 8 new cases of type 2 diabetes is in someone aged 18-40 years, compared with 1 in 10 in the year 2000.

The findings add to a growing body of evidence of an increased incidence of type 2 diabetes including worrying complications in younger people. Earlier this year, Medscape Medical News reported how young people diagnosed with type 2 diabetes in their early teens had an "alarming" high rate of diabetes-associated complications by the time they were in their mid-20s. Another study reported results showing that early treatment in teens with prediabetes or recent-onset type 2 diabetes failed to prevent deterioration in beta-cell function.

Sanjoy Ketan Paul, PhD, chair in clinical epidemiology, biostatistics & health services research, and Digsu Koye, PhD, clinical epidemiologist, both from the University of Melbourne, Australia, presented the results at this years Annual Meeting of the European Association for the Study of Diabetes (EASD).

"The very high HbA1c of 8.6% in the youngest group, with 71% obese, and around 72% with high LDL [low-density lipoprotein] levels, suggests we need to review our whole approach to screening in the UK and the wider world," said Paul.

"Type 2 diabetes doesnt happen overnight but develops over time with high risk exposure leading to the development of the disease at young age," he added. "We need to be more proactive in the holistic management of cardiovascular and cardiometabolic risk factors such as blood pressure, lipids and so on, in addition to lifestyle management and use intensive therapeutic interventions to manage these risk factors in this age group."

The study looked at the incidence of type 2 diabetes in the UK population over time, in particular at young onset type 2 diabetes compared with later onset; trends over time in the incidence of atherosclerotic CV disease (ASCVD) by age group; as well as the risk of ASCVD and all-cause mortality by risk status at time of diabetes diagnosis in each age group.

"We dont really know what is happening to the incidence of type 2 diabetes over time in younger compared with older people, and what the risk factors are at time of diagnosis. Also, do those diagnosed early on have a higher risk of developing CVD, different to the risk in older people?" Paul said. This study addressed these outstanding research issues.

Data were analysed on 343,714 people. Five age groups were evaluated: 18-40, 41-50, 51-60, 61-70 and 71-80 years. Patients did not have ASCVD at diagnosis.

The youngest group (18-39 years) had significantly higher body mass index (BMI) compared with older age groups, with a mean of35 kg/m2, and 71% were obese. Their mean HbA1c was 8.6% with 58% having levels 7.5%,and 71% had LDL levels 100 mg/dL.

In comparison, among those in the 41-50 year age group, 70% were obese, with a mean BMI of 34 kg/m2 and 55% had HbA1c of 7.5%

Data on anthropometric, clinical and laboratory measures, as well as comorbidities atdiagnosis of type 2 diabetes, microvascular disease and all-cause mortality were measured over a median follow-up of 7 years.

Trends over time in the proportion of people with a type 2 diabetes diagnosis in all the age groups were evaluated from 2000 to 2017, as well as the temporal trend for ASCVD and all-cause mortality.

"The temporal patterns show that the incidence of type 2 diabetes has been consistent over the past 5 to 7 years, with a marginal increase in the young onset people, at around 6% in 2006/7 and 8% at the end of the follow-up period," said Paul.

Women showed a striking trend over time. "In the youngest age group (18-40 years), females have a higher incidence of type 2 diabetes diagnosis, compared with a consistently reduced incidence in females in the 40-50 and 50-60 years age groups," he highlighted.

After diagnosis, the rate of development of ASCVD remained similar post-2007, following a decline since the year 2000, across all age groups.

The rate of all-cause mortality remained unchanged among those under-60 but declined in the 60+ age group, decreasing by around 20% in the 60-70 years group and 30% in 70-80 years group.

In the youngest group, the time to a first ASCVD event was the same irrespective of risk level at diagnosis. However, in older people (40 years +) there was a clear difference of around 2 years in development of ASCVD between high-risk and non-high-risk patients. "Similarly, in terms of time to death [all-cause mortality], in the youngest age group, the time to all-cause mortality is similar, but in the older groups there was a difference again."

Commenting from the audience, Dr Roy Taylor, professor of medicine and metabolism, University ofNewcastle, said: "These are interesting data. The decreased incidence in the oldest age group is of interest but surely this is an effect of earlier diagnosis of type 2 diabetes with increasing adiposity in the population over recent decades."

Dr Naveed Sattar, from the University of Glasgow, who was moderating the session pointed out that, "It was likely that we are screening less and we are missing a lot of people at younger age. Because of the level of acquisition we are probably not capturing everyone in the community."

EASD 2019 Annual Meeting. Presented September 18, 2019. Abstract #82

COI: Dr Paul reported no relevant disclosures.

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VERIFY: Metformin + DPP-4 Inhibitor as Dual Therapy for Diabetes? – Medscape

Posted: September 19, 2019 at 9:52 am

BARCELONA, Spain For patients newly diagnosed with type 2 diabetes, the recommended strategy of initiating treatment with metformin and then stepping up treatment with a second agent if monotherapy fails to control blood glucose might not be ideal, a new large, 5-year trial suggests.

Rather, initial dual therapy may be better.

Among patients with newly discovered diabetes whose HbA1C level was 6.5% to 7.5% (48 58 mmol/mol), those who initially received combination therapy with metformin plus the dipeptidyl peptidase4 (DPP-4) inhibitor vildagliptin (Galvus, Novartis) were less likely to experience sustained treatment failure (HbA1C 7% [53 mmol/mol]) during a 5-year period.

Lead investigator David R. Matthews, DPhil, EASD president and professor emeritus of diabetic medicine, University of Oxford, in the United Kingdom, and two coinvestigators presented these findings from the Vildagliptin Efficacy in Combination With Metformin for Early Treatment of Type 2 Diabetes (VERIFY) trial here at the European Association for the Study of Diabetes (EASD) 2019 Annual Meeting. The findings were simultaneously published in the Lancet.

This is the largest long-term prospective trial to test the durability of glycemic control in patients with diabetes who were initially treated with dual combination therapy, Ofri Mosenzon, MD, and Gil Leibowitz, MD, from Hebrew University of Jerusalem, Israel, write in an editorial that accompanies the Lancet article.

The study should "reassure" clinicians that initial dual therapy with these two agents "is well tolerated, safe and effective," they note.

Moreover, this finding was not unexpected, because these medications have synergistic mechanisms: metformin increases insulin sensitivity, and vildagliptin enhances beta-cell function.

The study "strengthens the notion that early combination therapy could have long-term clinical benefits regarding glycemic durability," they summarize.

They note, however, that in recent years, a number of large trials have shown that newer glucose-lowering agents, mainly GLP-1-receptor agonists and SGLT2 inhibitors, "have cardiovascular and renal benefits and the place of metformin as the first drug for all patients with type 2 diabetes is [now] questioned."

VERIFY coauthor Michael Stumvoll, MD, University Hospital Leipzig, Germany, told Medscape Medical News that VERIFY was begun long before most current GLP-1 agonists and all SGLT2 inhibitors were available.

When recruitment for VERIFY began in 2012, "we were in a world where gliptins were just becoming fashionable," Stumvoll said.

"Vildagliptin a beta-cell-preserving, weight-neutral, safe drug was leading the market," he said.

Vildagliptin is still widely used around the world, he stressed.

"It's a 'fire and forget' type of thing, a fixed dose, one in the morning and in the evening," and clinicians don't need to worry about impaired kidney function, weight gain, or hypoglycemia, he said.

Some practitioners have been using initial combination therapy off label, he added. This trial provides evidence to support this practice.

About 40% of patients did not experience treatment failure on metformin monotherapy.

However, Matthews said, "The point is, you don't know who these patients [who do well on monotherapy] are."

"What I think is important," senior author Stefano Del Prato, MD, University of Pisa, Italy, told Medscape Medical News, is that this is the first large, randomized clinical trial that shows that "a combination of the two drugs that are known to be safe...can preserve glycemic control over time." His words echo the comments of the other speakers and editorialists.

He said that further study is needed to see whether improved glycemic control lowers risk for cardiovascular disease.

VERIFY was designed to determine whether clinicians should start with combined therapies or use a stepwise approach (starting with metformin and then adding vildagliptin if metformin failed to provide adequate glycemic control) for patients with diabetes, Matthews said.

From 2012 to 2014, VERIFY enrolled 2001 patients who had been newly diagnosed with type 2 diabetes in 254 centers in 34 countries.

The patients were 18 to 70 years old and had been diagnosed with type 2 diabetes within the previous 2 years.

In these patients, the range of HbA1C, level was narrow, at 6.5% to 7.5%, Stumvolt noted. Body mass index values ranged from 22 to 40 kg/m.

The patients were randomly assigned either to the early combination treatment group (998 patients) or to the initial metformin monotherapy group (1003 patients).

Those in the combination therapy group received metformin at a dose of 1000 mg, 1500 mg, or 2000 mg per day, plus vildagliptin at a dose of 50 mg twice daily.

The patients in the monotherapy arm received the same daily doses of metformin plus twice-daily placebo.

If at any time from 6 months to 5 years from the start of the trial the HbA1C level was not maintained below 7.0% with initial treatment (confirmed at two consecutive scheduled visits that were 13 weeks apart), patients in the metformin monotherapy group were given vildagliptin 50 mg twice daily (instead of placebo) in addition to metformin.

About 80% patients in each group completed the 5-year study.

During the first phase of the study (before therapy was stepped up for any patients receivingmonotherapy) 429 patients (43.6%) in the combination treatment group and 614 patients (62.1%) patients in the monotherapy group experienced treatment failure.

The median time to treatment failure was 36 months in the monotherapy group; treatment failure had not occurred by 5 years in the combination therapy group.

The risk for treatment failure was 49% lower with initial combination therapy than with initial monotherapy (hazard ratio, 0.51; P < .0001).

Both treatment approaches were safe and well tolerated. There were no unexpected or new safety findings, and no deaths occurred that were related to study treatment.

Early combination therapy was not associated with risk for hypoglycemia or increased body weight, Del Prato noted.

An ADA-EASD consensus report states that currently, "While there is some support for initial combination therapy due to the greater initial reduction of A1C than can be provided by metformin alone, there is little evidence that this approach is superior to sequential addition of medications for maintaining glycemic control or slowing the progression of diabetes."

According to Del Prado, on the basis of VERIFY, the wording should be changed to "there is now evidence...."

The study can only generate hypotheses regarding cardiovascular risk, because it was not designed to examine this. He believes, however, that the study is "opening up a new era" in diabetes treatment strategies.

VERIFY demonstrated durable glycemic control in a heterogeneous population that reflects typical patients with newly diagnosed type 2 diabetes who are seen in clinical practice, he summarized

"Whether early combination treatment strategy should be applied to all patients with type 2 diabetes" needs to be studied further, according to Mosenzon and Leibowitz.

The findings from VERIFY "suggest that early normalisation of blood glucose has a beneficial legacy effect that attenuates diabetes progression," the editorialists write.

Other studies have shown that normalizing blood glucose during the first year after diagnosis "was associated with decreased risk of microvascular and macrovascular complications," they state.

Often in clinical practice, treatment intensification is delayed, and patients are exposed to prolonged hyperglycemia.

"Early combination therapy with two or more glucose-lowering agents might become an effective strategy to prevent clinical inertia," they suggest.

On the other hand, combination treatment might increase the risk for side effects and is more costly. "Additional studies are needed to confirm that early combination treatment indeed halts the progression of diabetes," they write.

Many type 2 diabetes drugs are currently available that could be combined as initial dual therapy. Thus, "Further studies to assess the effects of different combination therapies on glycaemic durability and more importantly on the risk of late complications are necessary," they write.

The study was funded by Novartis. Matthews has served on advisory boards or as a consultant for Novo Nordisk, GlaxoSmithKline, Novartis, Eli Lilly, Sanofi-Aventis, Janssen, and Servier. He is currently the president of the European Association for the Study of Diabetes and has given lectures for Novo Nordisk, Servier, Sanofi-Aventis, Eli Lilly and Company, Novartis, Janssen, and Ach Laboratories. Stumvolt has received speaker's honoraria and consulting fees from Novartis, Novo Nordisk, AstraZeneca, Aegerion, Eli Lilly and Company, and Boehringer Ingelheim. Del Prato serves or has served on advisory boards for AstraZeneca, Boehringer Ingelheim, Eli Lilly and Company, GlaxoSmithKline, Hanmi Pharmaceuticals, Intarcia, Janssen Pharmaceutics, Merck Sharp & Dohme, Novartis, Novo Nordisk, Sanofi, Servier and Takeda; serves or has served on the speakers' bureau for AstraZeneca, Boehringer Ingelheim, Eli Lilly and Company, Janssen Pharmaceutics, Merck Sharp & Dohme, Novartis, Novo Nordisk, Sanofi and Takeda; and has received research support from Boehringer Ingelheim, Merck Sharp & Dohme, and Novartis. The three other coauthors are employed by and own stock in Novartis. Mosenzon has received advisory board and speaker's fees and a research grant through her institution from Novo Nordisk; advisory board and speaker's fees from Eli Lilly, Sanofi, Merck Sharp & Dohme, and Boehringer Ingelheim; advisory board and speaker's fees and a research grant through her institution from AstraZeneca; and speaker's fees from Teva that are unrelated to the editorial topic. Leibowitz has received advisory board and speaker's fees from Novo Nordisk; speaker's fees from Eli Lilly & Company; and advisory board and speaker's fees from Sanofi and AstraZeneca that are all unrelated to the editorial topic.

European Association for the Study of Diabetes (EASD) 2019 Annual Meeting: Presented September 19, 2019.

Lancet. Published online September 18, 2019. Abstract, Editorial

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VERIFY: Metformin + DPP-4 Inhibitor as Dual Therapy for Diabetes? - Medscape

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CGM, Not Insulin Pump, ‘Is What Makes Difference’ in Type 1 Diabetes – Medscape

Posted: September 19, 2019 at 9:52 am

BARCELONA Use of real-time continuous glucose monitoring (rtCGM) can help improve blood glucose control in people with type 1 diabetes whether they use an insulin pump or multiple daily injections (MDI) of insulin, new research suggests.

Three-year data from the Comparison of Different Treatment Modalities for Type 1 Diabetes Including Sensor-Augmented Insulin Regimens(COMISAIR) study were presented here at the European Association for the Study of Diabetes (EASD) 2019 Annual Meeting by Jan oupal, MD, PhD, Charles University, Prague, Czech Republic.

The results were simultaneously published in Diabetes Care.

At 3 years the longest duration of any CGM trial real-time (not flash) CGM was superior to self-monitored blood glucose (SMBG), or fingerstick, testing at least four times daily in reducing HbA1c in patients using both pumps and MDI, with little difference between the two insulin delivery modalities.

Only the rtCGM group had improvements in time-in-range and reduced time below range. Fewer patients using rtCGM experienced severe hypoglycemic episodes.

"It is not so important how insulin is delivered, but more important is how patients with type 1 diabetes monitor their glucose," oupal said during his presentation.

oupal also said that "CGM and multiple daily injections [of insulin] can be a suitable alternative to treatment with pumps and CGM for some patients," such as those who have achieved good control using that regimen, those who are only willing to accept one device on their bodies, or for reasons of accessibility/affordability.

Patients likely to do better with pump plus CGM regimens include those with the dawn phenomenon (a rise in blood glucose in the early morning) and those who are physically active and can benefit from temporarily lowered basal infusion rates. Patients with hypoglycemic unawareness may be ideal candidates for sensor-augmented pump therapy, he added.

"Individualization of treatment is important. However, according to the results of our trial, in the vast majority of cases, CGM is what makes the difference," oupal said.

Asked to comment, Julia Mader, MD, Medical University of Graz, Austria, agreed. "The majority of patients profit from rtCGM whereas the insulin delivery mode is really not that important and should be at the patients' preference. They are equal."

Many of the oIder studies that showed improved glycemic control with insulin pumps were conducted during the time prior to use of insulin analogs, she noted, so that the comparator of twice-daily injections of NPH and Regular insulin versus Regular in the pump is not an accurate reflection of today's modalities. Today, she said, "Multiple daily injection [of insulin] is much better than before."

Mader also noted that the "real-time" aspect of CGM is important.

Participants in the current study used either the Dexcom G4 or Medtronic Enlite sensors, not the Abbott Libre (ie, "flash" glucose monitoring or FGM).

In her practice in Austria, where many patients use FGM, many don't achieve HbA1c targets with either pump or injection therapy, she noted. That's probably due in part to the alarm feature of rtCGM but not flash monitoring and that flash monitoring is less accurate in the lower ranges of blood glucose levels.

"Real-time alarms are better than just having the data...I think that's why patients are more cautious," she said.

Mader also cautioned that in some cases the introduction of CGM or flash glucose monitoring might actually lead to an increase in HbA1c if the main initial effect is reducing hypoglycemic events, which should be explained to patients, she advised.

The real-world, nonrandomized study compared changes in HbA1c among 94 patients using one of four treatment regimens: insulin pumps with or without rtCGM (15 and 20 patients, respectively) and MDI with or without rtCGM (12 and 18 patients), and all participants also used SMBG.

All patients were adults with type 1 diabetes of at least 2 years' duration and baseline HbA1c 7.0%-10.0% (53-86 mmol/mol). A total of 88 participants completed all 15 study visits at 3-month intervals over 3 years.

At 3 years, the rtCGM + MDI and rtCGM + insulin pump groups had significantly lower HbA1c levels compared with the MDI and pump groups using SMBG, at HbA1c 7.0% (53 mmol/mol), P = .0002, and 6.9% (52 mmol/mol), P < .0001, versus 8.0% (61 mmol/mol), P = .3574, and 7.7% (61 mmol/mol), P = 1.00. There were no significant differences between the two CGM groups or the two fingerstick groups.

The proportions of patients who achieved HbA1c < 7% at 3 years were 48% with rtCGM + MDI and 43% with rtCGM + pump, compared to just 9% with SMBG + pump and 16% with SMBG + injections.

Improvements in time-in-range (70-180 mg/dL, 3.9-10.0 mmol/L) were 14.2% with rtCGM + MDI versus SMBG + MDI (P = .0007), 11.1% with CGM + injections versus SMBG + pump (P = .0016), 17.6% with rtCGM + pump versus SMBG + pump (P < .0001), and 14.5% with rtCGM + pump versus SMBG + pump (P < .0001).

Significant reductions in percentage of time below 70 mg/dL (3.9 mmol/L) were seen in both CGM groups but not the SMBG groups (P = .4847 and P = 1.000), respectively.

A total of seven severe hypoglycemic episodes occurred during the study, of which two were in the SMBG + pump group, three in the SMBG + injections group, and one in the rtCGM + pump group (but the patient was not wearing the CGM at the time). There were three episodes of diabetic ketoacidosis: one in the SMBG + pump group, one in the SMBG + MDI group, and one in the CGM + pump group. All were adjudicated.

COMISAIR was supported by grants from the Agency for Healthcare Research and the Ministry of Health of the Czech Republic. Soupal has reported serving as an advisory board member, consultant, and/or speaker for Novo Nordisk, Eli Lilly, Sanofi, Boehringer-Ingelheim, AstraZeneca, Medtronic, Roche, and Dexcom. Mader has reported being an advisory board member and/or speaker for Becton Dickinson, Boehringer Ingelheim, Eli Lilly, Medtronic, Sanofi, Abbott Diabetes Care, AstraZeneca, Nintamed, Novo Nordisk, Roche Diabetes Care, Sanofi, Servier, and Takeda.

EASD 2019 Annual Meeting. Presented September 19, 2019. Abstract 40.

Diabetes Care. Published online September 17, 2019. Abstract

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CGM, Not Insulin Pump, 'Is What Makes Difference' in Type 1 Diabetes - Medscape

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Novel Agent Imeglimin Improves Glucose Control in Type 2 Diabetes – Medscape

Posted: September 19, 2019 at 9:52 am

BARCELONA A novel investigational first-in-class drug called imeglimin (Poxel Pharma) has shown promise in treating type 2 diabetes in a phase 3 study conducted in Japan.

Findings from the Trials of Imeglimin for Efficacy and Safety (TIMES) clinical development program were presented September 18 during a symposium here at the European Association for the Study of Diabetes (EASD) 2019 Annual Meeting by Julie Dubourg, MD, Poxel's medical director of clinical development.

"In all phase 2 and phase 3 trials, imeglimin has demonstrated very robust efficacy in the type 2 diabetic population, as well as in subpopulations such as elderly patients and those with chronic kidney disease. The safety and tolerability profile is also very good. So this [may be] a new option for the treatment of patients with type 2 diabetes as mono- or add-on therapy," Dubourg told Medscape Medical News.

Imeglimin works by improving mitochondrial function, which in turn increases insulin secretion and insulin sensitivity in the muscle while also decreasing hepatic glucose production, Ralph A. DeFronzo, MD, professor of medicine and chief of the diabetes division at the University of Texas Health Sciences Center, San Antonio, said during the symposium.

Imeglimin is the first of what will be a new "glimin" class of glucose-lowering agents.

"These drugs actually correct three of the big problems that are present in our diabetic patients...It provides us with a new mechanism of action," DeFronzo said.

In addition, because preclinical data suggest that imeglimin also mobilizes fat in the liver, "this drug also has the potential to be used in [nonalcoholic steatohepatitis]," he noted.

Asked to comment, Harold E. Lebovitz, MD, professor of medicine at the State University of New York-Brooklyn, said: "The Japanese data are very impressive, but we don't know yet how other populations will respond to it."

"It is clearly a new class with unique mechanisms, but we have to define what that role is," he added.

Lebovitz, who conducted early studies on imeglimin but isn't involved in its development now, also pointed out that the drug could work in some patients for whom other classes of glucose-lowering agents might not be effective, or appropriate, such as those with kidney disease.

"Glucose-lowering drugs are not all for the same group of people...People with kidney disease are very sensitive and have a lot of hypoglycemia...Every drug is probably useful for a subset of patients because type 2 diabetes is not a single disease."

The ongoing phase 3 TIMES program with imeglimin includes three individual randomized, double-blind, placebo-controlled trials involving more than 1100 patients at 29 sites in Japan. TIMES 1, a 6-month monotherapy efficacy trial, TIMES 2, a 1-year safety trial with imeglimin as mono- and add-on therapy, and TIMES 3, a 16-week efficacy trial of imeglimin added to insulin, followed by a 36-week safety extension period.

Dubourg reported the results of TIMES 1 here at the EASD annual meeting. Patients had had type 2 diabetes for more than 3 months, were aged 20 years or older, were managed with diet and exercise, with or without one oral agent, and had a baseline HbA1c of 7-10%. Rescue therapy could be given after week 4 if necessary. A total of 213 participants were randomized and 205 completed the trial (103 were randomized to imeglimin and 102 to placebo).

The primary endpoint, change from baseline in HbA1c at week 24, was significantly greater with imeglimin compared to placebo (0.87%; P < .0001), consistent with results seen in a phase 2 trial that was pivotal in selecting the 1000-mg dose of imeglimin for the phase 3 trials, Dubourg said.

Fasting plasma glucose also dropped significantly at 24 weeks by an average of 19 mg/dL (P < .0001), also similar to the phase 2 results.

Proportions of patients achieving an HbA1c < 7% were 35.8% (from baseline of 7.99%) in the imeglimin group versus just 7.5% (from a baseline of 7.93%) with placebo. No patient in the imeglimin group required rescue therapy, whereas 5.7% of the placebo group did.

Results were consistent across age groups, above and below 65 years of age (both P < .0001), and across chronic kidney disease stages 1, 2, and 3 (P < .0900, P < .0001, and P = .0007, respectively).

Overall adverse event rates were similar (44.3% vs 44.9% for imeglimin and placebo, respectively). Gastrointestinal disorders occurred in 11.3% of patients with imeglimin versus 8.4% with placebo. There were no severe hypoglycemic events in either group.

Adverse events leading to study discontinuation were less common with imeglimin than placebo (2.8% vs 5.6%). Serious adverse events were more common with imeglimin (3.8% vs 0.9%). No deaths occurred.

TIMES 2 and TIMES 3 results are expected around the end of 2019.

Poxel expects to submit a New Drug Application for imeglimin in Japan by the end of 2020. Phase 3 trials will also be conducted in the United States and Europe.

EASD 2019 Annual Meeting. Presented September 18, 2019.

Dubourg is a Poxel employee. DeFronzo has reported being an advisor for, receiving research support from, and/or being a speaker for AstraZeneca, Novo Nordisk, Janssen, Boehringer-Ingelheim, Intarcia, Elcelyx, Janssen, and Merck. Lebovitz formerly consulted for Poxel but hasn't done so for more than a year and currently receives no funding from them. He now works with Indian biosimilar manufacturer Biocon.

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Blood Lipid Changes at Age 8 in Kids Genetically Prone to Diabetes – Medscape

Posted: September 19, 2019 at 9:52 am

BARCELONA Metabolic signs of type 2 diabetes are detectable in the blood of some children as young as 8 years old, according to the results of a large epidemiological study presented here at the European Association for the Study of Diabetes (EASD) 2019 Annual Meeting.

"It's remarkable that we can see signs of adult diabetes in the blood from such a young age this is about 50 years before it is commonly diagnosed," said lead researcher Joshua Bell, PhD, MRC Integrative Epidemiology Unit, University of Bristol, UK.

Bell and colleagues used data from the Avon LongitudinalStudyof Parents and Children (ALSPAC) study to look at the early features of type 2 diabetes in children aged 8 and older.

The researches assessed genetic liability in the kids using variants known to be associated with adult diabetes and calculated a genetic risk score, which was cross-referenced with metabolic markers in the blood measured at four time points as the children grew up, until the age of 25. The full articleis also available online.

"This was a way of trying to piece together what the disease looks like as it's developing," he told Medscape Medical News.

Specifically, one of the earliest features to change in the blood was metabolism of high-density lipoprotein cholesterol (HDL-C) or "good" cholesterol. Low levels of this marker appeared to be correlated with higher genetic likelihood of developing type 2 diabetes in adulthood, Bell explained

These changes occurred before any alterations in low-density lipoprotein cholesterol (LDL-C) or "bad" cholesterol.

Session moderator Naveed Sattar, MD, from the Institute of Cardiovascular & Medical Sciences at the University of Glasgow, UK, welcomed the work but pointed out that it is unlikely this information would be used clinically, at least at the present time.

"It does add a little bit of new information on what the pathways to diabetes may be so only of research interest currently not for the clinic for many years, if ever," he observed.

"We already have good risk scores based on questions and simple measurements of weight or waist...which help signal those at high risk [of diabetes] who should consider getting tested for it," he added.

Bell explained that type 2 diabetes takes many years to develop and, based on adult data, it has been established that disease-related changes can occur in the decade or two leading up to diagnosis.

"What we don't know is what the very early beginnings of disease look like," he explained.

Using the ALSPAC data (also known as the cohort of the 90s study), Bell and colleagues genotyped 4765 children for 162 genetic variants of adult type 2 diabetes and also examined lipid measures including triglycerides as well as a number of amino acids and fatty acids in blood samples taken at ages 8, 15, 18, and 25 years.

"We wanted to know the effect of that genetic susceptibility on blood markers. How early in life do we see the beginning of disease activity? And how does it unfold?" he told Medscape Medical News.

He acknowledged the findings "are more preclinical than clinical," but stressed they provide some early insight into "what features might be targeted to prevent progression to clinical disease."

Elizabeth Robertson, PhD, director of research at Diabetes UK, said the findings may indeed be of use in years to come.

"In the future, insights like these could mean we're able to spot who is at a higher risk and most importantly find ways to intervene to reduce this risk much earlier in a person's life than we're able to today and...potentially prevent more cases of type 2 diabetes from developing at all," she commented.

"Although we can't do anything about our genetic risk, there are things you can do to help lower your risk of developing the condition that include maintaining a healthy weight, eating well, and moving more," she noted.

EASD 2019 Annual Meeting. Presented September 19, 2019. Abstract 81.

Bell has reported no relevant financial relationships.

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Bayer steps up to take One Drop’s tech beyond diabetes, backs $40M round – FierceBiotech

Posted: September 19, 2019 at 9:52 am

One Drop, the digital health specialist that markets diabetes management tools, has found a new partner and investor in Bayer. The German pharma led One Drops $40 million series B round and licensed its technology for its bio-digital efforts in areas beyond diabetes.

New York-based One Drop offers hardware and software to help people manage their diabetes, including a Bluetooth-enabled blood glucose meter, test strips and lancets as well as a mobile app and various coaching programs. These are available individually or as part of a gestational diabetes package or a subscription-based diabetes package.

The One Drop app works with FitBit trackers and Dexcom glucose monitoring systems on iPhone and Android devices. Apple has even begun selling One Drops chrome-plated glucose meter alongside its iPhones and Apple Watches in some of its U.S. retail stores. These integrations, One Drop says, are why its reach is so deep. It estimates that nearly 1.5 million people in 195 countries use its technology.

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RELATED: Apple stores to stock chrome-plated glucose monitor from One Drop

Though aimed at diabetes, One Drop believes its platform could be used to track and manage a range of health conditionsand Bayer agrees. The Big Pharma will harness One Drops mobile platform across a broad array of therapeutic areas including oncology, heart disease and womens health.

"As part of our strategy to shape the future of healthcare and build new businesses in digital health, we are investing in integrated digital solutions to improve health outcomes through data driven solutions, said Stefan Oelrich, president of Bayers pharmaceuticals division, in a statement. "This collaboration allows us to obtain access to a world leading self-care platform for disease management beyond the boundaries of medicines with strong artificial intelligence-driven capabilities that could lead to better healthcare outcomes for people with chronic conditions."

As for the new $40 million infusion, One Drop will use it to invest in its growth and to further its mission to transform the lives of people with diabetes and other chronic conditions, Rachel Snchez-Madhur, vice president of consumer strategy and marketing, told FierceMedTech in an email.

This year will see continued growth in our consumer channels, and rapid growth in our employer channel, and an expanded effort to drive further ahead with our data science operations, she said.

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Looking In Your Eyes May Help Predict Diabetes Development – msnNOW

Posted: September 19, 2019 at 9:52 am

Pixabay Doctors may soon look into your eyes to see your risk of having diabetes. Researchers found that eye lens show changes in the body that may predict the disease even years before its development.

The new study, presented at the recent meeting of the European Association for the Study of Diabete (EASD) in Spain, used a newly developed biomicroscope to observe advanced glycation end-products (AGEs) in the eye. High levels of AGEs can contribute to a number of diseases, including eye nerve damage and neuropathy.

The biomicroscope sends blue light to the eye lens to measure its autofluorescence and inform researchers aboutthe levels of AGEs. Researchers tested the device in a healthy control group and 40 people diagnosed with either prediabetes or type 2 diabetes.

Each participant underwent comprehensive medical and neurological assessments prior to the study. They then took tests with the biomicroscope to measure their lens autofluorescence.

Results showed that autofluorescence in the lens of the eye could help predict a persons diabetes risk. The people with type 2 diabetes and impaired glucose tolerance or prediabetes appeared with significantly high AGE levels in their eyes.

"The results of this preliminary study showed the lens autofluorescence is significantly greater in patients with prediabetes and type 2 diabetes, Mitra Tavakoli, lead researcher from the University of Exeter Medical School in England, said in a statement. The level of AGE products were correlated with the levels of blood sugar."

The findings support previous studies that suggested initial signs of diabetes may appear up to ten years before the disease starts to affect the body. Researchers of the latest study said their approach may give earlier detection, which increases the chance of preventing future complications.

"Lens autofluorescence could be a robust marker of long-term diabetes control predicting future complication risks, Tavakoli said. This supports the feasibility of non-invasive lens autofluorescence to screen subjects for undiagnosed type 2 diabetes and prediabetes subjects.

Researchers said the new approach to detecting diabetes earlier may also help reduce complications in people with type 2 diabetes because of timely intervention. However, they noted larger and long-term clinical studies are required to support their initial findings.

Related video: Diabetic Women More At Risk of Heart Failure Than Men (Provided by Veuer)

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