Category Archives: Diabetes

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Schizophrenia and Psychosis

Longstanding evidence suggests that schizophrenia is associated with type 2 diabetes mellitus (DM2). The research includes maternal and birth studies that identify common risk factors for both conditions, including nulliparity, gestational diabetes, preeclampsia, birth weight, and season of birth.1 Studies before the advent of antipsychotics showed an increased prevalence of abnormal glucose metabolism in patients with schizophrenia, albeit with methodological limitations.2 There is also evidence for impaired glucose tolerance and insulin resistance in patients with first-episode psychosis who are either antipsychotic-nave or have minimal antipsychotic exposure.3,4

These findings suggest that some of the increased risk of DM2 in schizophrenia may be independent of antipsychotic medications and involve host-agent-environment interactions. However, this hypothesis has largely been overshadowed by known metabolic adverse effects of second-generation antipsychotic medications, which increase the risk of DM2.

Methodology

Schizophrenia is associated with an increased risk of the metabolic syndrome, a constellation of metabolic risk factorsincluding abnormal glucose toleranceassociated with cardiovascular disease morbidity and mortality.5 In an earlier study, patients with schizophrenia and other non-affective psychoses (NAP) and a parental history of DM2 were found to have a 3.7-fold increased odds of comorbid DM2 compared with patients without this parental history.6

A meta-analysis was undertaken to understand the association between a family history of DM2 and DM2 comorbidity in patients with NAP.7 Studies were identified by systematically searching Medline, PsycInfo, Web of Science, and Science Direct. Non-affective psychosis was defined to include schizophrenia, schizophreniform disorder, brief psychotic disorder, delusional disorder, schizoaffective disorder, and psychotic disorder not otherwise specified. One hundred thirty-six potential studies were identified; however, most were excluded because of missing family history data about DM2, or because the diagnoses were primarily affective psychosis. Case reports were also excluded. After a detailed review, 10 studies met the inclusion criteria

Data used included number of subjects with and without a family history of DM2 based on comorbid DM2 status, as well as other clinical and demographic variables. Effect size estimates (odds ratios [ORs] and 95% confidence intervals [95% CIs]) were calculated using the random effects method. Given significant between-study heterogeneity, a sensitivity analysis and a series of meta-regressions to explore possible moderating variables we used to account for heterogeneity (eg, age, sex, geographic region, body mass index, year of publication, study quality).

The total sample consisted of 3780 patients with non-affective psychoses, including 804 subjects with a family history of DM2 and 2976 without a family history of DM2. A family history of DM2 was associated with more than a four-fold increased odds of comorbid DM2 (OR=4.3, 95% CI 2.9-6.4, P < .001), with significant between-study heterogeneity. In sensitivity analyses, after removing two outlying studies with the highest OR, the association remained significant (OR=3.3, 95% CI 2.6-4.3, P < .001), but between-study heterogeneity was no longer significant. A funnel plot and Eggers test were not significant for publication bias, although findings should be interpreted with some caution given the small number of studies. In meta-regression, there was a significant, positive association with age, but all other potential moderating factors were unrelated to the association between comorbid DM2 and family history of DM2.

Strengths and weaknesses >

References:

1. Kandhal P, Miller BJ. Shared early life risk factors for schizophrenia and diabetes. Minerva Psichiatrica. 2013;54:197-210.

2. Kohen D. Diabetes mellitus and schizophrenia: historical perspective. Br J Psychiatry. 2004;184:64-66.

3. Greenhalgh AM, Gonzalez-Blanco, L, Garcia-Rizo C. et al. Meta-analysis of glucose tolerance, insulin, and insulin resistance in antipsychotic-nave patients with nonaffective psychosis. Schizophr Res. 2017;179:57-63.

4. Perry BI, McIntosh G, Weich S, et al. The association between first-episode psychosis and abnormal glycaemic control: systematic review and meta-analysis. Lancet Psychiatry. 2011;11:1049-1058.

5. McEvoy JP, Meyer JM, Goff DC, et al. Prevalence of the metabolic syndrome in patients with schizophrenia: baseline results from the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) schizophrenia trial and comparison with national estimates from NHANES III. Schizophr Res. 2005;80:19-32.

6. Miller BJ, Goldsmith DR, Paletta N, et al. Parental type 2 diabetes in patients with non-affective psychosis. Schizophr Res. 2016;175:223-225.

7. Chung J, Miller BJ. Meta-analysis of comorbid diabetes and family history of diabetes in nonaffective psychosis. Schizophr Res. 2019 (In press).

8. Papazafiropoulou AK, Papanas N, Melidonis A, Maltezos E. Family history of type 2 diabetes: does having a diabetic parent Increase the risk? Curr Diabetes Rev. 2017;13:19-25.

Read more from the original source:
Family History of Diabetes: Is There an Association With Non-Affective Psychosis? - Psychiatric Times

Over 400 million individuals worldwide, according to the World Health Organization (WHO), have diabetes, living each day on the precipice of health determined by the level of sugar in their bloodstream. The vigilance required to ensure that their levels are neither too high nor too low can often become all-encompassing. A circumstance that Lonny Stormo, co-founder and CEO of the Oak Park Heights, Minnesota-based startup, Pops, truly understands.

Lonny Stormo, Co-founder and CEO of Pops

Stormo brought his proficiency in electrical engineering and business to the medical device industry over three decades ago. He has served in various executive leadership roles during his thirty-year career at industry giant Medtronic, and even collaborated with NASA. Though his work at Medtronic was primarily focused on cardiovascular health, he developed a vested interest in diabetes care when, in his mid-thirties, Stormo was diagnosed with adult onset type 1 diabetes.

As an active member of his community and an avid runner, Stormo was often frustrated by the encumbrance that conventional blood sugar monitoring would have on his lifestyle. After fifteen years of observing the same testing and tracking regimen, this medical device industry veteran began to question whether there was a better way to do this.

How can it be with all the advances we were making in medicine, that I had been managing my diabetes the same exact way these years, with the same black zip-up bag holding a meter and test strips and a lancing tool that you had to assemble, says Stormo, describing the equipment that those with diabetes typically use to keep track of their daily blood sugar levels, The test kit was too big to carry around wherever I went. Besides, I was not comfortable taking everything out to run a test in front of everybody and often there would not be a table around for me to set things up on. It was all very inconvenient.

Stormo suggested that because of the inconvenience associated with this cumbersome approach, many with diabetes, as he often did, would just leave their test kits at home. Beyond seeing their blood sugar level results perhaps, a couple times a day while at home, many do not have any idea what their true status is. That is, until the next biannual medical exam when the HbA1C test that indicates the prior months blood sugar level average, is performed. By then, if the readings suggest their blood sugar concentration has been too high, any deterioration to their health that could result may have already taken place.

Poor self-monitoring of blood sugar levels over time is a leading cause of long-term health complications for those with diabetes complications that range from nerve damage, vision loss, kidney failure, heart attacks, stroke and lower limb amputation to death. According to the most recent report from the International Diabetes Foundation (IDF) citing data for 2017, approximately four million deaths globally were attributed to known cases of diabetes, thus placing it among the top ten causes of mortality worldwide (WHO 2018). Associated healthcare costs, in 2017 alone, amounted to $727 billion USD globally of which 48% was attributed to individuals living in the United States. Americans with diabetes spent on average $12,000 USD on health care in 2017, which is twice the cost incurred by those who live without diabetes (numbers taken from IDF 2017 report).

Stormo recognized that the struggles he faced managing his own care reflected the experience of millions of others in the US and is implicated in the high health care costs for those with diabetes. So, he decided to do something about it.

He leveraged his decades of experience and extensive network in the medical device field to gather a team of like-minded colleagues co-founders, Dan Davis, Pops current Security Officer and VP of R&D, and Curt Christensen, Pops VP of Operations with a mission to improve the lives of those with diabetes. Thus, in 2015, Pops Diabetes Care was launched by this team that understands what living with diabetes is like, and who are determined to make it easier for those with diabetes to control their blood sugar levels, therefore reducing their risk of expensive health complications.

Our vision is lowering the worlds A1c one person at a time, Stormo explains.

Their strategy involves addressing the reasons why many individuals do not adhere to regular testing. A Reality of Diabetes Care Survey reported by the Canadian-based Medical Education Network (Mednet) back in 2010, identified several of these reasons thus validating what those dealing with these challenges daily have been saying for years. These reasons, further characterized in subsequent studies, include forgetfulness, insufficient time for regular testing, not having all the things needed to test, unreliable meters, not wanting to carry around the equipment for the tests, pain and testing anxiety, inability to test discretely, lack of motivation, and even concerns regarding safe disposal of the used test strips and lances. A daunting list of deterrents that Stormo and his team were all too familiar with.

If we want people to manage their diabetes all the time and do it better, says Stormo, We have to give them a better experience. What we have done is reengineered that experience to make it easy for them to test their blood sugar less painfully, discretely, no assembly needed, anywhere, at any time, with non-invasive, non-judgmental virtual coaching.

Stormo and his team developed a portable test kit that can (doesnt have to) pop-on to the back of a smartphone to which it interfaces via wireless connection to a Pops virtual management care app.

I can now literally check my blood sugar anytime, anywhere while I am on the road for a run, something I could never do before, explains an enthusiastic Stormo, One time at a business competition, I was standing on stage and it was time to check my blood sugar levels. So right there in front of hundreds of people, I quickly pulled out my phone and discretely did a test. Simple. No fuss.

The Pops approach aligns with the current shift in individual behavior being observed across the healthcare landscape. Subject to a conventional system that does not always serve their best interests, patients are less passively resigned to receive services offered as is. Rather they are being more selective about their care and are actively pursuing alternatives that confer better outcomes.

This increasing demand for consumer-focused healthcare services is further bolstered by the recent acceleration in technological innovation. In an imperfect healthcare system, where many struggle to access appropriate care, it is not surprising that individuals are seeking solutions through advanced technologies that enhance the delivery of such care.

A 2017 report by consulting group, Deloitte Development LLC, indicates that over 70% of consumers in the US prioritize access thus are comfortable using virtual health platforms to manage their own care or coordinate with providers. According to Statista, 77% of US adults surveyed over a two-month period in 2018 were satisfied with their virtual care experience, confirming this trend.

People want to take healthcare into their own hands using technology, says Stormo, Previously, we were using technology to connect patients and doctors, sending information to the doctor then waiting for the doctor to respond with what to do, perhaps via a video console. Now people are managing their health directly using easy, convenient, smart technology. And living their lives. This is the next step virtual care people are empowered to self-manage their conditions.

Pops not only includes an integrated virtual care system they call Rebel, but also Mina, a 24/7, non-judgmental personal virtual coach. Rebel and Mina together provide non-invasive blood sugar-testing and monitoring along with basic analytics that inform guidance and support. In addition, everyone using the system is considered an owner controlling how and with whom, if anyone, their information is shared, whether its with friends, family and/or caregivers.

At Pops, we are enabling you to take care of yourself, to own your condition, to own your life, says Stormo, You have diabetes, but it does not define you. You are a person first and foremost.

Last year, Pops patented system received FDA clearance. Since then, they have established partnerships with healthcare plans and employers who have included Pops in their employee benefits offerings, promoting healthier employees, greater productivity at work, and an associated reduction in company healthcare costs. In the future, Stormo would like for everyone with diabetes to have access to Pops, regardless. For now, the system is not yet directly available to the consumer.

This purpose-driven company has been gaining attention across the country. Pops recently closed an oversubscribed Series A funding round of $6 million USD as a result of heightened investor interest. The round was led by 30Ventures, a healthcare and biotechnology venture capital firm based out of Madison, Wisconsin.

Also participating in this round was New York-based investment firm, Flying Point Industries and Revolutions Rise of the Rest Seed Fund, a Washington D.C.-based firm founded by AOL co-founder Steve Case that focuses on funding highly promising seed stage companies outside the startup hubs of Silicon Valley, New York City, and Boston.

In a recent press release, Stormo expressed his gratitude for the strong investor support, We are pleased that investors see this commercial growth as a sign that diabetes virtual care is making a difference for people with diabetes. The funds will be used to further the commercialization of Pops system.

Pops was also recently chosen to participate in the 2019 Winter Insurtech program run by globally renowned startup accelerator, Plug and Play.

Though grateful for the validation and support received this year, for Stormo, nothing comes close to the fullfilment he experienced that memorable day, when Pops received the first testimonial from the first person whose HbA1C levels were lowered by 1.5 points using the Pops system.

The first thing we see each day walking through the front doors is his framed photo the first person whose life we changed, says Stormo proudly, That is what our mission is all about!

For more information about Lonny Stormo and Pops, visit http://www.popsdiabetes.com.

REFERENCES:

https://www.who.int/news-room/fact-sheets/detail/the-top-10-causes-of-death

http://www.mednet.ca/docs/pdf/HO10-005_E_with_WM.pdf

Josh Nelson, Bryan Sung, Sunil Venkataram, and Jennifer Moore, Transforming care delivery through virtual health, Deloitte, 2017.

View post:
Pops on the go virtual care system empowers those with diabetes to Own Their Life - Silicon Prairie News

Im sure youve heard the joke before: someone is eating something that contains a lot of sugar and says Im going to get diabetes to make fun of themselves for being unhealthy. Or maybe they look down at the dessert in front of them and say, this looks like diabetes on a plate. I hear these kinds of jokes constantly, and its time I finally do something about it.

Not only are these jokes inconsiderate toward people who have been affected by diabetes, but they are also inaccurate in the message they spread about the disease. People commonly view diabetes Type 2 in particular as being something that people get because they eat poorly and dont exercise. Although lifestyle is a factor, there are other prominent causes, including genetics, age and ethnicity. In many cases, diabetes occurs when a predisposition is inherited, then the onset of diabetes is triggered by environmental factors.

For instance, both Type 1 and Type 2 diabetes run in my family. This means that I am more likely to develop the disease than someone else with a similar lifestyle but no family history of it. So, before you make a joke about being diabetic simply because youve eaten a large amount of sugar, you should consider just how false the assumption you are making is. An unhealthy lifestyle can contribute to diabetes, but that does not mean it should be interpreted as the disease you get when you dont look after your health.

However, the thing that bothers me most about diabetes jokes is that they are completely inconsiderate toward people with the disease and people who have loved ones with the disease. Imagine seeing your loved one suffer from the complications of diabetes and work hard every day to control it, then getting to school and overhearing someone joke about going into a candy-bar-induced diabetic coma. These kinds of jokes make it seem as if diabetes is nothing more than a disease that people with poor diets have. However, diabetes causes much more suffering and requires much more care than most people are aware of.

Once diagnosed, people with diabetes have to take extremely good care of themselves every day. This often includes frequent finger pricks to monitor blood sugar levels and self-administered insulin shots. Even while doing things like this, they experience complications that worsen over time. According to Medical News Today, some of the possible complications for Type 2 diabetes are heart and blood vessel diseases, high blood pressure, nerve damage, foot damage, eye damage and blindness, kidney disease, hearing problems and skin problems. So when someone makes light of this life-altering and debilitating disease, you can see why that would be highly offensive.

Considering that over 30 million people have been diagnosed with diabetes in the U.S., there is always a good chance that someone who has the disease or someone who has a loved one with the disease can overhear you joking about it. Next time you make a joke about something, keep in mind the people around you and how your words could hurt those people.

Read the original here:
Diabetes isn't something to joke about - The JagWire

Type 2 diabetes causes a persons blood sugar level to become too high, and if blood sugar isnt controlled properly and stays too high, a number of problems can occur including kidney failure, nerve damage, heart disease and stroke.

So what can be done to prevent the condition and keep blood sugar levels in check?

Eating a healthy diet is just one of the ways blood sugar levels can be managed.

The NHS advises: "Theres nothing you cannot eat if you have type 2 diabetes, but youll have to limit certain foods.

You should eat a wide range of foods - including fruit, vegetables and some starchy foods like pasta, keep sugar, fat and salt to a minimum, and eat breakfast, lunch and dinner every day - do not skip meals.

READ MORE:How to get rid of visceral fat: The best drink to reduce the harmful belly fat

But when it comes to the first meal of the day, breakfast, one food that should be avoided is cereal bars.

Diabetes UK states: Cereal bars arent always as healthy as they appear.

For a better breakfast snack on the go, grab some fresh fruit and a handful of nuts instead.

Combine it with a glass of semi or skimmed milk to keep hydrated and get essential calcium for your bones and teeth.

DON'T MISS

Cereal can also hold a similar problem. The diabetes charity adds: Although the packaging may make some cereals - like granola and cereal clusters - appear healthy, they are often full of free sugars and unhealthy fat.

Some childrens cereals also have a lot of free sugar.

Instead, they not switch to porridge? Porridge oats or the instant variety are both fine - just avoid those with added free sugars like honey and golden syrup.

Wheat biscuits, shredded wheat or muesli (with no added sugar) are also great alternatives. For sweetness, add chopped fruit.

Read the rest here:
Type 2 diabetes: The food you should avoid eating for breakfast to lower blood sugar - Express

The Food and Drug Administration (FDA) has expanded the indication for Toujeo (insulin glargine; Sanofi) 300 Units/mL to include treatment of pediatric patients aged 6 years with diabetes mellitus. Previously, Toujeo was indicated for use in adults aged 18 years.

The approval was based on data from the phase 3, randomized, open-label, multicenter EDITION JUNIOR trial that compared the efficacy of Toujeo 300 Units/mL to Lantus (insulin glargine) 100 Units/mL in 463 patients aged 6 to 17 years with type 1 diabetes for at least 1 year. The primary end point was the change from baseline in HbA1c to Month 6. Results showed an adjusted mean change from baseline in HbA1c of -0.386% with Toujeo vs -0.404% with Lantus (adjusted mean difference: 0.018; 95% CI -0.159, 0.195).

With regard to safety, a similar percentage of patients in both groups experienced 1 event of severe and/or documented (70mg/dL) hypoglycemia (97% and 97.8% for Toujeo 300 Units/mL and Lantus 100 Units/mL, respectively). Numerically, the percentage of patients who experienced severe hypoglycemia or had 1 event of hyperglycemia with ketosis (ketones 1.5mmol/L) was lower with Toujeo compared with Lantus.

Toujeo, a long-acting human insulin analog, is available as 1.5mL SoloStar and 3mL Max SoloStar prefilled pens in 3-count packs.

For more information visit sanofi.com.

Go here to read the rest:
Toujeo Approved for Pediatric Patients With Diabetes - Monthly Prescribing Reference

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Lifestyle Changes To Prevent Type 2 Diabetes Offered At YMCA - CBS Denver

Looking for stocks with high upside potential? Just follow the big players within the hedge fund industry.Why should you do so? Lets take a brief look at what statistics haveto say about hedge funds stock picking abilities to illustrate. The Standard and Poors 500 Index returned approximately 26% in 2019 (through November 22nd). Conversely, hedge funds 20 preferred S&P 500 stocks generated a return of nearly 35% during the same period,withthe majority of these stock picks outperforming the broader market benchmark. Coincidence? It might happen to be so, but it is unlikely. Our research covering the last 18 years indicates that hedge funds' consensus stock picks generate superior risk-adjusted returns. That's why we believe it is wise to check hedge fund activity before you invest your time or your savings on a stock likeTandem Diabetes Care Inc (NASDAQ:TNDM).

Tandem Diabetes Care Inc (NASDAQ:TNDM) has seen an increase in hedge fund sentiment in recent months. Our calculations also showed that TNDM isn't among the 30 most popular stocks among hedge funds (click for Q3 rankings and see the video below for Q2 rankings). Video: Click the image to watch our video about the top 5 most popular hedge fund stocks.

5 Most Popular Stocks Among Hedge Funds

In the financial world there are a large number of tools investors have at their disposal to grade stocks. A pair of the most under-the-radar tools are hedge fund and insider trading indicators. We have shown that, historically, those who follow the top picks of the best fund managers can outperform the broader indices by a solid amount. Insider Monkey's flagship best performing hedge funds strategy returned 91% since May 2014 and outperformed the Russell 2000 ETFs by nearly 40 percentage points. Our short strategy outperformed the S&P 500 short ETFs by 20 percentage points annually (see the details here). That's why we believe hedge fund sentiment is a useful indicator that investors should pay attention to.

Samuel Isaly Orbimed Advisors

Unlike the largest US hedge funds that areconvinced Dow will soar past 40,000 or the world's most bearish hedge fundthat'smore convinced than ever that a crash is coming,our long-short investment strategy doesn't rely on bull or bear markets to deliver double digit returns. We only rely on the best performing hedge funds' buy/sell signals. Let's take a gander at the new hedge fund action regarding Tandem Diabetes Care Inc (NASDAQ:TNDM).

Heading into the fourth quarter of 2019, a total of 34 of the hedge funds tracked by Insider Monkey held long positions in this stock, a change of 3% from the second quarter of 2019. On the other hand, there were a total of 22 hedge funds with a bullish position in TNDM a year ago. So, let's find out which hedge funds were among the top holders of the stock and which hedge funds were making big moves.

Story continues

No of Hedge Funds with TNDM Positions

Among these funds, Renaissance Technologies held the most valuable stake in Tandem Diabetes Care Inc (NASDAQ:TNDM), which was worth $76.3 million at the end of the third quarter. On the second spot was Redmile Group which amassed $68.4 million worth of shares. Consonance Capital Management, Columbus Circle Investors, and OrbiMed Advisors were also very fond of the stock, becoming one of the largest hedge fund holders of the company. In terms of the portfolio weights assigned to each position Consonance Capital Management allocated the biggest weight to Tandem Diabetes Care Inc (NASDAQ:TNDM), around 5.97% of its portfolio. Sectoral Asset Management is also relatively very bullish on the stock, dishing out 4.4 percent of its 13F equity portfolio to TNDM.

With a general bullishness amongst the heavyweights, some big names have jumped into Tandem Diabetes Care Inc (NASDAQ:TNDM) headfirst. Consonance Capital Management, managed by Mitchell Blutt, initiated the most outsized position in Tandem Diabetes Care Inc (NASDAQ:TNDM). Consonance Capital Management had $60.3 million invested in the company at the end of the quarter. Peter S. Park's Park West Asset Management also made a $32.4 million investment in the stock during the quarter. The other funds with brand new TNDM positions are Jeffrey Jay and David Kroin's Great Point Partners, Chuck Royce's Royce & Associates, and John Osterweis's Osterweis Capital Management.

Let's go over hedge fund activity in other stocks similar to Tandem Diabetes Care Inc (NASDAQ:TNDM). These stocks are CarGurus, Inc. (NASDAQ:CARG), White Mountains Insurance Group Ltd (NYSE:WTM), Colfax Corporation (NYSE:CFX), and Macquarie Infrastructure Corporation (NYSE:MIC). This group of stocks' market caps are similar to TNDM's market cap.

[table] Ticker, No of HFs with positions, Total Value of HF Positions (x1000), Change in HF Position CARG,21,813076,1 WTM,16,185765,-1 CFX,30,652861,3 MIC,26,231644,-2 Average,23.25,470837,0.25 [/table]

View table hereif you experience formatting issues.

As you can see these stocks had an average of 23.25 hedge funds with bullish positions and the average amount invested in these stocks was $471 million. That figure was $587 million in TNDM's case. Colfax Corporation (NYSE:CFX) is the most popular stock in this table. On the other hand White Mountains Insurance Group Ltd (NYSE:WTM) is the least popular one with only 16 bullish hedge fund positions. Compared to these stocks Tandem Diabetes Care Inc (NASDAQ:TNDM) is more popular among hedge funds. Our calculations showed that top 20 most popular stocks among hedge funds returned 37.4% in 2019 through the end of November and outperformed the S&P 500 ETF (SPY) by 9.9 percentage points. Hedge funds were also right about betting on TNDM as the stock returned 17% during the first two months of Q4 and outperformed the market by an even larger margin. Hedge funds were clearly right about piling into this stock relative to other stocks with similar market capitalizations.

Disclosure: None. This article was originally published at Insider Monkey.

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Hedge Funds Have Never Been This Bullish On Tandem Diabetes Care Inc (TNDM) - Yahoo Finance

BOSTON, Dec. 03, 2019 (GLOBE NEWSWIRE) -- Beta Bionics, Inc. a medical technology company developing and aiming to commercialize the worlds first fully automated bionic pancreas today announced that its bionic pancreas glucose control algorithms that use lifelong autonomous learning were deployed in a pilot study comparing usual care with automated insulin-only and bihormonal (insulin and glucagon) delivery in three patients with cystic fibrosis related diabetes (CFRD). Results of the study were published in the Journal of Cystic Fibrosis (J.S. Sherwood, R.Z. Jafri, C.A. Balliro, et al., Automated glycemic control with the bionic pancreas in cystic fibrosis-related diabetes: A pilot study, Journal of Cystic Fibrosis, https://doi.org/10.1016/j.jcf.2019.08.002).

Researchers at the Massachusetts General Hospital performed a three-arm, random-order, cross-over, pilot study comparing the bihormonal bionic pancreas versus the insulin-only bionic pancreas versus usual care for CFRD. The bionic pancreas dosing algorithms utilized in this pilot study were identical to those used in other studies in subjects with type 1 diabetes. There were no restrictions on activity and subjects continued their normal diet, exercise, and work throughout the study. The bionic pancreas was initialized only with subject body weight, without any information regarding their usual insulin regimen.

Given the sample size of the study, only descriptive statistics were reported for the group. The group mean blood-glucose level, as measured by continuous glucose monitoring (CGM), was nominally lower in both the bihormonal (139 15 mg/dl) and insulin-only (149 10 mg/dl) bionic pancreas study arms relative to the usual care study arm (159 35 mg/dl). During bionic pancreas arms, subjects used the meal announcement feature on average less than once per day, and survey data suggested that subjects had a decreased diabetes-management burden. Subjects reported they spent less time thinking about diabetes, felt more freedom with food choices, and had overall greater peace of mind.

We are encouraged by the results of this pilot study suggesting that our bionic pancreas technology can potentially be deployed in multiple conditions of glycemic disregulation, including CFRD, said Ed Damiano, President and Chief Executive Officer of Beta Bionics. We look forward to continuing our commitment to innovation through clinical research as we plan to test multiple applications of our technology in further clinical studies in an effort to maximize the potential good our technology and company can bring to the diabetes community.

This pilot study was supported by the National Institutes of Health under award number R01DK119699-01.

About Beta Bionics

Beta Bionics is a for-profit Massachusetts public benefit corporation founded in 2015 to commercialize the iLet, a revolutionary bionic pancreas that is driven by mathematical dosing algorithms, which incorporate lifelong autonomous learning to automatically control glycemia. These mathematical dosing algorithms were developed in the Damiano Lab at Boston University and refined based on results from home-use clinical trials in adults and children with T1D. Beta Bionics is a Certified B Corporation whose founders in addition to Ed Damiano include other parents of children with type 1 diabetes and people with type 1 diabetes. Beta Bionics is committed to acting in the best interests of the diabetes community and to profoundly disrupting the diabetes medical device industry by bringing the iLet to market as expeditiously and responsibly as possible. Beta Bionics is pursuing regulatory approval of its insulin-only bionic pancreas, followed by its dual-hormone system, which will also administer a glucagon analog in order to raise blood-sugar levels without the need to consume carbohydrates.

Beta Bionics operates in Massachusetts and California. For further information, please visit http://www.betabionics.com or follow Beta Bionics Facebook, YouTube, Instagram, LinkedIn and Twitter @BetaBionics.

Ed Damianoedamiano@betabionics.com

Ed Raskineraskin@betabionics.com

Investor Relations ContactJeremy Fefferjeremy@lifesciadvisors.com

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Encouraging Results of Pilot Study Testing Bionic Pancreas in Cystic Fibrosis-Related Diabetes Published in Journal of Cystic Fibrosis - GlobeNewswire

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The U.S. Food and Drug Administration (FDA) approved an expanded indication for Sanofis Toujeo (insulin glargine injection) for blood sugar control in adult and pediatric patients who are ages six years and older. This applies to both type 1 and 2 diabetes. Previously, Toujeo was approved only for adults aged 18 years and older.

The company announced the results of the EDITION JUNIOR clinical trial earlier in the month. It was the first randomized, controlled trial to compare Toujeo to Gla-100 in this patient population. The trial met its primary endpoint, demonstrating comparable decreases in average blood sugar over six months with both treatments and similar risk of low blood sugar events (hypoglycemia). In fact, the proportion of patients experiencing severe low blood sugar events and high blood sugar (hyperglycemia) with ketosis was numerically lower with Toujeo.

Based on the data, the European Medicines Agency (EMA)s Committee for Medicinal Products for Human Use recommended the expanded label in Europe.

Across the globe, between 50 and 80% of young people living with type 1 diabetes need more treatment options to help them achieve an average blood sugar level below 7.5%, said Dietmar Berger, Global Head of Development at Sanofi, at the time. By taking this step toward investigating an additional option for children and adolescents living with diabetes, we hope to provide another treatment for them and their physicians, to develop an individualized treatment plan that helps patients better manage their disease.

The EDITION JUNIOR study compared Toujeo to Gla-100 in 463 children and adolescents aged six to 17 years who had type 1 diabetes. They were evaluated for at least one year. They had HbA1C levels between 7.5% and 11.0% at the time of screening. The patients continued to use their existing mealtime insulin throughout the study.

The primary endpoint was non-inferior reduction of HbA1C after 26 weeks.

Insulin glargine injection is a long-acting, manufactured insulin. The injection holds three times as much insulin in 1ml as a standard 100 units/ml insulin.

Toujeo was originally approved for adults by the FDA in February 2015. Its primary competition is Novo Nordisks ultra-long-acting degludec, marketed as Tresiba. Both Toujeo and Tresiba are dosed once daily. The original insulin glargine is marketed by Sanofi as Lantus. It is facing competition from Boehringer Ingelheims Basaglar, the first insulin glargine follow-on approved by the FDA. It launched in 2016 after a patent battle with Sanofi.

In 2018, Toujeo brought in $840 million, while its Lantus sales dropped from $4.63 billion to $3.57 billion. Novo Nordisks Tresiba brought in $1.22 billion in 2018.

We know that living with type 1 diabetes means dealing with highs and lows in blood sugar, which are worrying and present substantial challenges for young people, said Thomas Danne, director of the Department of General Pediatrics and Endocrinology/Diabetology at the Childrens Hospital on the Bult, Hannover Medical School, Germany. In addition to the trial demonstrating safety and efficacy, the percentage of patients with severe hypoglycemia, and the percentage with hyperglycemia with ketosis, were numerically lower with Toujeo.

More:
FDA Approves Sanofi's Toujeo to Treat Childhood Type 1 and 2 Diabetes - BioSpace

A review of the literature demonstrates the value of the diabetes specialist nursing role for people with diabetes in hospital

There is a profound mismatch between the capacity of the diabetes specialist nurse (DSN) workforce and the steadily rising demand for diabetes services in the UK. A literature review of evidence in the field highlights the reasons for this, and the necessity to protect and propagate the DSN workforce.

Citation: Lawler J (2020) The role of specialist nurses for people with diabetes in hospital. Nursing Times [online]; 116: 1, 18-19.

Author: Jessica Lawler is research associate, London South Bank University.

An estimated one in six hospital beds are occupied by people with diabetes (NHS Digital, 2018), costing the NHS around 10bn a year (Diabetes UK, 2014). However, the number of diabetes inpatient specialist nurses in post is significantly lower than the recommended one per 250 beds (NHS Digital, 2017). In total, 22% of hospitals have no diabetes specialist nurses (DSNs) at all and only 12% provide a seven-day service (NHS Digital, 2019).

Lack of title protection or a national accreditation framework for DSNs, means there is wide variation in credentialing and role structure. This can reduce the potential for peer support and means specialist nurses from different trusts have varying expectations, training and experience. NHS Englands (2019) NHS Long Term Plan specifies that all hospitals should provide a DSN service to reduce variations in care. A literature review of evidence on the DSN workforce has clarified the ways they improve patient outcomes and experiences (Lawler et al, 2019); this article summarises its findings.

Caring for people with diabetes in hospital requires expertise in treatment and an understanding of how diabetes may affect care (NHS Digital, 2019). NHS England (2016) states the benefits of DSN interventions include reducing inpatient harm, including prescription errors and medication errors. In 2017, 31% of inpatients with diabetes experienced at least one diabetes-related medication error (NHS Digital, 2017). Furthermore, hospital-acquired emergency states, such as diabetic ketoacidosis and hyperglycaemia, are potentially fatal, yet preventable. In 2017, 28% of inpatients with diabetes did not see a specialist diabetes team when they should have (Diabetes UK, 2018).

DSNs respond to crises, prevent patient deterioration, and provide safe and consistent care. In addition, specialist nurses are widely acknowledged to reduce unscheduled care (Read, 2015). Reasons (2000) Swiss Cheese model showed safety is more than just the absence of harm; specialist nurses ensure the delivery of safe care, rather than simply reducing errors.

As well as reducing inpatient harm, DSNs:

Reduced length of stay is an often-used metric to determine the effectiveness or value of DSNs (NHS England, 2019). However, it should not be the only target or measure of quality or effectiveness and it is not an accurate or representative guide of safe care. Other factors to consider are:

The wide-reaching benefits of specialist nurses are well documented but narrowly measured (Leary, 2011).

Working in partnership with people who have diabetes to promote self-management is an invaluable part of educative interventions by DSNs. Improving their understanding of the physical, social and emotional effects of the condition, along with the tools to manage and cope with these effects, is part of comprehensive care. Providing psychological care for patients, and support and advice for families and carers, is also crucial.

As Lawler et al (2019) elucidate, education by DSNs is usually given in one-to-one therapeutic conversations, and associated with improved outcomes. There is a long-standing debate around the effectiveness and suitability of providing bedside education in hospital, but the review suggests disempowerment is common in people with the condition in hospital, and that diabetes education is critical for those with newly diagnosed diabetes to reduce avoidable hospital admissions.

DSNs also provide continuity of care for people with diabetes when they are in hospital whether for diabetes-related issues or other conditions giving essential care and managing complex needs and care planning. This undoubtedly improves the patient experience and quality of care.

With the wealth of evidence showing their value, why are there significantly fewer DSNs than recommended and how can this be remedied? The specialist nursing workforce is continuously asked to prove its worth, with nurses having to fight to remain in post or for posts to be created. Simplistic perceptions and short-term cost considerations often prevent consideration of the benefits and necessity of specialist nurses, and long-term financial and economic benefits are often ignored (Read, 2015).

Workforce pressures, and a shortfall in specialist nurses, mean the task of training new DSNs falls on teams already struggling with their workload. Yet moving from crisis management to proactive care relies on having a well-staffed and stable workforce. The review calls for accreditation and protection of specialist nursing titles, along with increased inpatient DSN roles to meet, if not surpass, national targets.

Appropriate and effective use of DSNs for inpatients is important in ensuring high standards of care. The NHS Institute for Innovation and Improvement launched its ThinkGlucose campaign in 2009 with the aim of improving the care, outcomes and experience of people with diabetes in hospital. The campaign, which used a traffic-light system to advise staff which patients should be referred to specialist diabetes teams, reduced inappropriate referrals, and increased diabetes knowledge and awareness among other hospital staff (Eaglesfield, 2012). Although the tool was created to improve the efficiency of DSNs work, the way it is used in practice is not explicitly recorded or defined. Further reporting using such tools could help demonstrate the benefits of DSNs.

Increasing the accessibility and convenience of care is important and telemedicine is now viewed as a way to provide guidance to patients about next steps or when to seek advice from a health professional. It involves specialist assessment and active listening to meet patients information needs and educate them on symptom control, and is particularly well received for people with long-term conditions.

Diabetes care should be patient centred and tailored to the individual to promote confidence in self-management. The review concluded that telemedicine was a cost-effective way for DSNs to deliver care. As well as enabling follow-up for some recently discharged patients without them needing to visit a clinic or make an appointment, it purportedly reduces the number of acute hospital admissions. DSNs ran telephone helplines, as well as holding telephone appointments or check-ins, to support rather than substitute direct contact care.

DSNs reportedly have limited access to, and time for, professional development. This could threaten the future of the role by creating problems with recruitment and retention. There is no census of DSNs in the UK and, therefore, no way of accurately predicting future workforce needs. Currently one in 15 people in the UK have diabetes and this proportion is predicted to rise (NHS Digital, 2018). An annual national census of the diabetes workforce would enable the NHS to plan for a sustainable and efficient workforce capable of meeting the demands of an increasing diabetes workload. Although undertaking the census might add to current workload pressures, short-term action may be needed for long-term success.

The review shows DSNs improve care and outcomes for people with diabetes by:

There is a profound mismatch between the limited capacity of the DSN workforce and the steadily rising demand for diabetes services in the UK. The results of Lawler et als (2019) literature review highlight the necessity to protect and propagate the DSN workforce.

Diabetes UK (2018) Making Hospitals Safe for People With Diabetes.

Diabetes UK (2014) The Cost of Diabetes: Report.

Eaglesfield B (2012) ThinkGlucose at an acute hospital a roller-coaster project. Journal of Diabetes Nursing; 16: 9, 356-362.

Lawler J et al (2019) Does the diabetes specialist nursing workforce impact the experiences and outcomes of people with diabetes? A hermeneutic review of the evidence. Human Resources for Health; 17: 65.

Leary A (2011) How nurse specialists can demonstrate their worth. Gastrointestinal Nursing; 9: 6, 46-49.

NHS Digital (2019) National Diabetes Inpatient Audit: Hospital Characteristics, 2018: England and Wales.

NHS Digital (2018) National Diabetes Inpatient Audit: England and Wales, 2017.

NHS Digital (2017) National Diabetes Inpatient Audit (NaDIA): 2016.

NHS England (2019) The NHS Long Term Plan.

NHS England (2016) National Diabetes Treatment and Care Programme: Introduction to and Supporting Documentation for Value Based Transformation Funding Site Selection.

Read C (2015) How specialists can help you. In: Time for Some Advanced Thinking? The Benefits of Specialist Nurses.

Reason J (2000) Human error: models and management. BMJ; 320: 768.

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The role of specialist nurses for people with diabetes in hospital - Nursing Times