The US FDA has approved Tidepool Loop, an app designed to automate insulin dosing. Born out the do-it-yourself, "we are not waiting" movement, it has designs and features not in the first wave of commercial automated systems like Omnipod 5 and Tandem’s Control IQ. CEO Howard Look talks to Stacey about what was approved here and what Tidepool Loop is all about.
If you’ve followed this story closely, you’re going to be surprised to learn about a few changes that have happened along the road to approval.. and to learn the questions that Tidepool will have to answer next.
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Learn more about Tidepool: https://www.tidepool.org/
Our previous episodes with Howard Look:
Please visit our Sponsors & Partners - they help make the show possible!
Check out VIVI Cap to protect your insulin from extreme temperatures
Learn more about AG1 from Athletic Greens
The best way to keep up with Stacey and the show is by signing up for our weekly newsletter:
Sign up for our newsletter here
Here's where to find us:
Learn more about everything at our home page www.diabetes-connections.com
Reach out with questions or comments: info@diabetes-connections.com
How are those New Year's resolutions going? By this time, it’s possible you’ve given up. But maybe it's just that you’ve set your goals a little too high.
This week, Stacey talks to Ben Tzeel, Founder of Your Diabetes Insider, Registered Dietitian, Certified Diabetes Care & Education Specialist, Certified Strength & Conditioning Specialist. Ben also lives with type 1. We’re going to talk about how to make the changes you want in a way that helps you stick with it. AND he’s going to share some of his experience in a trial where he ate – no joke – about four thousand calories at one meal!
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Join the Diabetes Connections Facebook Group!
Sign up for our newsletter here
Episode Transcription Below (or coming soon!)
Please visit our Sponsors & Partners - they help make the show possible!
It’s In the News, a look at the top stories from the diabetes community from the last seven days. This week: Cost Plus pharmacy starts putting out feelers about insulin, asking people to take part in a pilot program, EO Flow looks at the US market for their new patch pump, quite a few new studies about type 2 diabetes drugs, a study about slowing down type 1 in kids and much more!
Learn more about the T1D exchange and drive research that matters! www.t1dexchange.org/stacey
Join the Diabetes Connections Facebook Group!
Sign up for our newsletter here
Episode Transcription Below (or coming soon!)
Please visit our Sponsors & Partners - they help make the show possible!
Hello and welcome to Diabetes Connections In the News! I’m Stacey Simms and these are the top diabetes stories and headlines of the past seven days.
XX
In the news is brought to you by The T1D Exchange - Help drive research that matters.
XX
Possible new player in the US Patch pump business. EO Flow has submitted a 510(k) application to the FDA for its EOPatch wearable, disposable insulin pump. EO Flow is based in California and has launched the pump in South Korea. The company also has FDA breakthrough device designation on an integrated artificial pancreas. The website says EOPancreas is a wearable disposable artificial pancreas system that integrates a continuous glucose sensor and an insulin pump in one small wearable module and autonomously controls insulin infusion. They’re looking for a US partner for the pump and hope to launch in 2024.
http://www.eoflow.com/eng/eopatch/eopatch_010100.html
https://www.drugdeliverybusiness.com/eoflow-submits-insulin-patch-pump-fda-clearance/
XX
Your time in range before getting a COVID vaccine may predict your body’s response. This was a small study, 25 patients with type 1 who received two doses of a COVID vaccine. Researchers followed the group two weeks before before and six months after the shots.
Main outcome measures: The primary exposure and outcome measures were pre-vaccination glucose control, and antibody response after vaccination, respectively. Patients meeting the recommended pre-vaccination glucose targets of TIR (≥70%) and TAR (≤25%), developed stronger neutralizing antibody titres (p < 0.0001 and p = 0.008, respectively), regardless of HbA1c. highlighting a role for well-controlled blood glucose in vaccination efficacy.
https://pubmed.ncbi.nlm.nih.gov/36611249/
XX
New study in kids with type 1 seems to show that the drug golimumab – brand name Simponi – can help preserve beta cell function. This is the Tiger study which included people ages 6 to 21 years old with T1D and given either the drug or a placebo for 52 weeks the off the drug for another year. The group taking the drug used less insulin and had a higher c peptide level in the time after the medication stopped, indicating that there was a difference.
https://diabetesjournals.org/care/article-abstract/doi/10.2337/dc22-0908/148228/Two-Year-Follow-up-From-the-T1GER-Study-Continued?redirectedFrom=fulltext
XX
New study confirming what a lot of you already know, Metformin failure in people with type 2 diabetes is very common, particularly among those with high A1c levels at the time of diagnosis.
An analysis of electronic health record data for more than 22,000 patients starting metformin at three US clinical sites found that over 40% experienced metformin failure. This was defined as either failure to achieve or maintain A1c less than 7% within 18 months or the use of additional glucose-lowering medications. "These results call into question the ubiquitous use of metformin as the first-line therapy and suggest a more individualized approach may be needed to optimize therapy," they add in their article published online in the Journal of Clinical Endocrinology and Metabolism.
The investigators identified a total of 22,047 metformin initiators from three clinical primary care sites: the University of Mississippi's Jackson centers, which serves a mostly African American population, the Mountain Park Health Center in Arizona, a seven-clinic federally qualified community health center in Phoenix that serves a mostly Latino population, and the Rochester Epidemiology Project, which includes the Mayo Clinic and serves a primarily White population.
https://www.medscape.com/viewarticle/986994
XX
The FDA has approved a label update for semaglutide that allows the drug to be used in addition to diet and exercise as a first-line option to improve glycemic control in adults with type 2 diabetes. The brand name here is Wegovy. With its initial FDA approval in 2019, semaglutide became the first and only glucagon-like peptide-1 (GLP-1) analog in pill form.
https://www.pharmacytimes.com/view/fda-approves-label-update-for-semaglutide-allowing-use-as-first-line-option-for-adults-with-type-2-diabetes
XX
Merk says it’s diabetes drugs Januvia and Janumet have become contaminated with a potential carcinogen.. and it can resolve the problem by the end of the year. The company submitted a report to the U.S. Food and Drug Administration (FDA) and other regulators. The impurity arose mostly during storage, as well as during manufacturing, Bloomberg News said. The FDA said in August certain samples of sitagliptin, a compound in Merck's diabetes drugs Januvia and Janumet, were contaminated with a possible carcinogen.
https://www.bloomberg.com/news/articles/2023-01-17/merck-mrk-ready-to-remove-cancer-linked-chemical-from-diabetes-drugs-in-2023
XX
Researchers studying new methods for improving blood sugar control in type 2 diabetes have discovered an old class of antipsychotic drugs may offer clues to a novel kind of treatment for hyperglycemia. While the researchers propose the old drugs could be directly repurposed to treat diabetes, they could also be slightly modified to more specifically target blood sugar control.
The class of drugs, known as (DPBPs), were developed back in the 1960s and are still used today. The researchers say they “They all improve blood sugar control by preventing the muscle from burning ketones as a fuel source.”
Because the DPBP drugs are already approved medicines the researchers hope to quickly move to proof-of-principal human trials. This would establish whether these preclinical findings are reproducible in human patients.
The new study was published in the journal Diabetes.
https://newatlas.com/medical/old-antipsychotic-drugs-new-class-diabetes-treatment/
XX
Another study showing an AID system works well for people with type 2. Scientists from University of Cambridge set up a small study, no surprise, the closed loop system did a lot better than standard injection therapy – people stayed in target range 66-percent of the time versus 32-percent with shots. That was an additional 8 hours a day of time in range.
https://www.medicalnewstoday.com/articles/type-2-diabetes-artificial-pancreas-may-soon-be-an-option
XX
Dexcom gives us a little more information about the G7. I interviewed Kevin Sayer for this week’s long format interview and he says the G7 will launch in the US during this first quarter.. so by the end of March. He also gave a more pessimistic view for interoperability with Tandem and Omnipod than we’ve heard – with Tandem end of summer early fall and Omnipod 5 next year. It’s up to those companies, not Dexcom.
XX
T1D Exchange
XX
On the podcast next week.. how are those new year’s resolutions going? If you haven’t kept them up, maybe you tried to do too much at once? Nutritionist Ben Tzeel joins me to talk about how to get back on track.
I mentioned last week’s episode with Dexcom CEO Kevin Sayer. We talk about the G7 launch and lots more, including their plans for the type 2 community and moving into “health”
That’s In the News for this week.. if you like it, please share it! Thanks for joining me! See you back here soon.
We've got new information about Dexcom’s G7 launch and much more. CEO Kevin Sayer says it’ll be available in the US before the end of March. Sayer joins us from the J.P. Morgan Healthcare Conference in San Francisco. He talks about Dexcom’s pump partners, when the FDA will let them put in features they already have in Europe but not here, and answers a lot of your questions.
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Stacey mentioned this link during the episode: www.dexcom.com/g6-medicare
Join the Diabetes Connections Facebook Group!
Sign up for our newsletter here
Episode Transcription Below (or coming soon!)
Please visit our Sponsors & Partners - they help make the show possible!
Dad and daughter, Randall and Emma Barker, were diagnosed at the same age (ten) and have a few other coincidences around their experiences with T1D. They have a close relationship and this week, they share their story.
The Barkers are here to talk about eye health – we get help from the American Diabetes Association's Dr. Laura Hieronymus to talk about treatment and prevention of complications, which Randall has. But we also talk about what it’s been like for Emma to watch her father live with type 1 and then be diagnosed herself and Randall shares his own feelings of guilt.. and pride. This is a good one.
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Join the Diabetes Connections Facebook Group!
Sign up for our newsletter here
Episode Transcription Below (or coming soon!)
Please visit our Sponsors & Partners - they help make the show possible!
It’s In the News, a look at the top stories from the diabetes community from the last seven days. This week: predictions of a huge increases in cases of type 2, insulin prices are capped for those with Medicare, Omnipod commits to a basal-only pump for people with type 2, and more!
In the news is brought to you by Athletic Greens! Find out more: https://athleticgreens.com/stacey
Join the Diabetes Connections Facebook Group!
Sign up for our newsletter here
Episode Transcription Below (or coming soon!)
Please visit our Sponsors & Partners - they help make the show possible!
Hello and welcome to Diabetes Connections In the News! I’m Stacey Simms and these are the top diabetes stories and headlines of the past seven days.
XX
In the news is brought to you by Athletic Greens! AG1 is way more than greens it’s daily nutrition made really simple
XX
New study says the number of young people in the United States with diabetes will increase by nearly 700% over the next 40 years. This was a projection study using numbers from the past 20 years and was published in the journal Diabetes Care. The CDC believes that "the increasing prevalence of childhood obesity," as well as "the presence of diabetes in people of childbearing age," could be two reasons for why the number of young Type 2 diabetics has increased so rapidly. There is some evidence that COVID 19 may also have something to do with more cases of diabetes but there isn’t enough data to know for sure.
https://www.wibw.com/2023/01/03/cdc-predicts-huge-spike-diabetes-among-young-adults-next-40-years/
XX
As of January first, the monthly out-of-pocket cost of insulin is capped at $35 for seniors on Medicare. That’s part of the Inflation Reduction Act in effect on Jan. 1. In August, Republicans blocked a provision in the bill that would have capped the out-of-pocket cost of the drug for everyone on private insurance. There was no provision for the uninsured. It’s not clear whether insulin pricing will come up again during this new congress.
https://www.nbcnews.com/health/health-news/insulin-cost-cap-people-diabetes-no-benefit-rcna58165
XX
Insulet is planning a basal only pump, looking at the type 2 market to compliment their Omnipod pump. The newly announced device is designed for patients with Type 2 diabetes who receive daily or weekly injections of basal insulin. Unlike Insulet’s other devices, it doesn’t have a controller, but has a built-in basal conversion rate. They hope to have it on the market by 2024. In an earnings call late last year Insulet announced a 42-percent increase in revenue in the US. They’ll plan a European launch of Omnipod 5 in mid-2023.
https://www.medtechdive.com/news/insulet-omnipod-5-q3-earnings-record-PODD/635811/
XX
Beta Bionics appoints a new Chief Medical Officer as the company quote - for the commercial launch of the iLet Bionic Pancreas System. As of right now, the iLet is still in front of the FDA but it sounds like it may be getting close to approval. Dr. Steven Russell is the new CMO here.. Dr. Russell has directed nearly all of the bionic pancreas clinical trials. The bionic pancreas – renamed the iLet a few years ago – operates using only the person’s body weight, no basal rates or other settings – and input about the size of meals, not carb counts.
https://www.newswire.com/news/beta-bionics-appoints-dr-steven-russell-as-chief-medical-officer-in-21920409
XX
Lilly’s Emergency Glucagon Kit is now out of production. They announced last year that they will discontinue the red box emergency kit at the end of 2022 in the US. The company says with newer options like Baqsimi nasal spray, Gvoke and Zegalogue pens, the demand isn’t there. If you do prefer the older kit – really the only way to do those mini-glucagon shots some people really like – there are still two options – Novo’s GlucaGen Hypo Kit – the orange box and a generic made by Amphastar.
https://diatribe.org/glucagon-options-expand-lilly-discontinues-emergency-kit
XX
Another move forward to islet transplantation. Houston Methodist Medical Center in Texas delivered islet cells and immunotherapy directly into a 3D-printed device named NICHE, which is similar to a bioengineered pancreas. It’s about the size of quarter and goes under the skin. There’s a tiny port that means the device can be refilled with medication. These researchers say they’re probably three years from human trials.
https://www.jpost.com/health-and-wellness/article-726001
XX
The US Food and Drug Administration has approved semaglutide brand name Wegovy for teenagers with obesity. When Wegovy was approved for use in adults with obesity in June 2021, it was labeled a "game changer." The results in teens – who also received what they call lifestyle intervention – were close to the results seen after bariatric surgery. Wegovy is a once weekly shot – it’s also sold with a lower dose as a type 2 treatment with the brand same Ozempic. Same drug, lower dose.
https://www.medscape.com/viewarticle/986403
XX
XX
On the podcast next week.. A father and daughter who both live with type 1 – they were diagnosed at the same age – talk about their experience with eye health. What’s changed and what’s still the same for people with diabetes. And we get guidance and info about prevention and treatments available.
Last week’s show our 2023 prediction episodes!
That’s In the News for this week.. if you like it, please share it! Thanks for joining me! See you back here soon.
----
Happy new year! What will 2023 bring for diabetes technology? We bring our best guesses to the table and we take a look back at what we said would happen last year. Stacey is joined by Chris Wilson on a Twitter Spaces Chat and you'll also hear from Mike Hoskins for a look back to 2022.
Mike is currently an editor at Healthline and formerly the managing editor at DiabetesMine. Chris Wilson, is a longtime advocate and information junkie who just marked 25 years with type 1. Chris will tell you that for much of his time with diabetes he didn’t have insurance and didn’t use a lot of the more advanced tech.. and now he really follows it all very closely, takes part in clinical trials and is designing his own pretty incredibly sounding DIY closed loop features.
None of the three have financial stakes in these companies, past some stocks that may be buried in mutual funds – we don’t’ own individual stakes in these companies. And their information is based on whatever is publicly available.
Check out Stacey's book: The World's Worst Diabetes Mom!
Join the Diabetes Connections Facebook Group!
Sign up for our newsletter here
Episode Transcription Below (or coming soon!)
Please visit our Sponsors & Partners - they help make the show possible!