artificial pancreas

Could AID Transform Type 2 Diabetes Care?

Posted by

0


While AID has traditionally been used in type 1 diabetes, new data suggests this technology has many of the same benefits in type 2 – namely, improving time in range and A1C while reducing hypoglycemia. Plus, AID dramatically simplifies blood sugar management. 

From continuous glucose monitoring (CGM) to automated insulin delivery (AID) systems, diabetes technologies that began as innovations for people with type 1 diabetes are slowly beginning to reach people with type 2.

For instance, many insurance companies now cover CGMs for people with type 2 diabetes who take insulin as well as those who are not on insulin but have a history of hypoglycemia. And earlier this week, the FDA approved Stelo by Dexcom, a CGM designed specifically for people with type 2 diabetes who are not taking insulin.

However, less progress has been made with reimbursement by insurance companies for AID. Off-label use of AID drew significant attention at the ATTD 2024 conference, with presenters highlighting the benefits for many people with diabetes across a range of settings and systems.

AID improves time in range across different systems and settings

Research shows that AID leads to many of the same benefits in type 2 diabetes as in type 1 diabetes: improved time in range, reduced hypoglycemia, and reduced A1C. Importantly, these benefits were consistent across different study settings and regardless of which AID system was used.

A study of 30 Tandem Control-IQ users with type 2 diabetes found that time in range increased by about 15% from 56% at baseline to 71% at six weeks. This translates to an increase of 3.6 hours per day spent in range.

Dr. Anders Carlson, diabetes medical director at the International Diabetes Center in Minnesota, said this finding is in line with studies in type 1 diabetes as well as the time in target range guidelines for type 1 diabetes.

Outside of clinical trials, research suggests that the benefits of AID extend to people with type 2 diabetes in the “real world.”

In a study presented at ATTD, MiniMed 780G users were able to achieve 71-75% time in range outside of a clinical trial, again meeting the targets for diabetes. “This is really compelling evidence that in a real-world setting, this AID system can work for people with type 2 diabetes,” Forlenza said.

Participants who used the recommended MiniMed 780G settings (i.e. the lowest glucose target) achieved a time in range of 80%.

For Carlson, this finding raises an important question – what are the optimal settings for AID in type 2 diabetes? For instance, since low blood sugar (hypoglycemia) is less of a concern, it may be beneficial to have more aggressive targets from the get-go.

Another study investigated the Omnipod 5 AID system in 24 participants with type 2 diabetes, finding strong improvements in time in range with minimal hypoglycemia. Among those on MDI, time in range increased from 43% at baseline to 58% at six months. Participants on basal insulin only saw even larger improvements in time in range, from 31% at baseline to 65% at six months.

Dr. Anne Peters, professor of medicine at USC, also highlighted reductions in total daily insulin dose among participants on MDI – yet another way in which AID could simplify type 2 diabetes management.

How might combining AID with GLP-1s and SGLT-2s affect glucose levels?

Growing use of GLP-1 receptor agonists, SGLT-2 inhibitors, and diabetes technology poses new questions for the future of diabetes care. That is, how might the combination of technology and medications optimize outcomes for people with type 2 diabetes?

In the Omnipod 5 study, half of the patients were also taking a GLP-1 or SGLT-2. Overall, Omnipod users taking a GLP-1 or SGLT-2 saw greater improvements in time in range compared to those who were only taking insulin. Participants in the GLP-1 or SGLT-2 group saw a 24% increase in time in range from 28% at the start of the study to 62% at eight weeks. Meanwhile, participants not using a GLP-1 or SGLT-2 improved their time in range by 18%, from 35% at baseline to 53% at eight weeks.

Carlson said this finding suggests that combining GLP-1s or SGLT-2s with AID could potentially lead to even better glycemic control than AID alone – though formal studies will be needed to test this hypothesis.

Similarly, Dr. Gregory Forlenza, associate professor of pediatric endocrinology at the University of Colorado, noted the ability of GLP-1s to reduce insulin needs. Combining these powerful medications with AID may help people with type 2 diabetes improve glycemic control and lose weight. It’s possible these improvements could even help people work toward diabetes remission.

What about AID for older adults with type 2 diabetes?

Starting insulin can be challenging for people of all ages, but it can be especially complex for older adults or disabled people with type 2 diabetes who receive home care.

Elderly people have a higher risk of severe hypoglycemia and hypoglycemia or ketoacidosis. Diabetes management for older adults can also be complicated by impaired cognition or dementia, reduced mobility, and difficulty accessing care.

In this context, the CLOSE AP+ study investigated AID assisted by nurses in people with type 2 diabetes unable to manage their own multiple daily injections (MDI) at home. CLOSE AP+ tested Control-IQ technology in 25 participants who had an average age of 70 years.

At 12 weeks, time in range improved significantly, from 37% to 63%. Time below range was less than 1%, while time above range was under 10%. Overall, Reznik highlighted that a majority of participants reached the American Diabetes Association guidelines for older people with diabetes. These guidelines recommend:

  • At least 50% time in range (70-180 mg/dL)
  • Less than 1% time below range (<70 mg/dL)
  • Less than 10% time above range (>250 mg/dL)

It’s also worth noting that participants using Control-IQ technology saw a significant 1.3% reduction in A1C. Over 90% of participants reached an A1C of less than 8% by the end of the trial, without any increase in severe hypoglycemia. Dr. Yves Renzik, professor of endocrinology at CHU Caen Normandy in France, also highlighted high patient confidence and high nurse satisfaction with the AID system in this study.

Ultimately, the CLOSE AP+ study showed that AID can be used safely in people with type 2 diabetes who require home nursing care. This confirms the benefits of AID extend beyond the “standard” person with type 2 diabetes to older adults and people with disabilities.

The bottom line

Numerous presentations at ATTD 2024 demonstrated that AID is safe and effective for people with type 2 diabetes. Both clinical trials and real-world data show that this technology increases time in range and improves A1C while minimizing hypoglycemia.

“I want to emphasize that across a wide variety of real world and clinical trial evidence sets, and across very different AID systems, everyone is either doing a great job hitting a goal for time in range or achieving a massive improvement in glucose control,” Forlenza said. He noted that AID leads to time in range increases of 15% to 24% in people with type 2 diabetes, nearly double the improvements typically seen in type 1 diabetes.

However, several questions remain to be answered regarding optimal settings, bolusing, and the potential of AID when combined with GLP-1s and SGLT-2s. Carlson highlighted the following areas for further research:

  • Are people on MDI the only candidates for AID? Or could AID be used in all people with type 2, regardless of their insulin needs and whether or not they’re meeting glycemic goals?
  • Is previous experience with technology necessary for successful use of AID in people with type 2 diabetes?
  • Does AID help with diabetes self-management (such as carb awareness)?
  • What role will primary care providers provide in supporting AID in this population?

Beyond glycemic data, it’s also important to consider user experience with AID. Overall, the data suggests that people with type 2 diabetes had good satisfaction and confidence in using these systems. Even people who hadn’t previously used diabetes devices reported a positive experience with AID, Peters noted.

“I honestly wasn’t sure my patients would like AID – many were technology-naive people,” Peters said. “But they loved it and they wanted to stay on it because they felt it improved their glycemic control.”

Artificial Pancreas Improves Blood Glucose Control in Young Kids with Type 1 Diabetes

Posted by

0


Smiling young girl with a photo of an insulin pump

Last week brought some great news for parents of small children with type 1 diabetes (T1D). It involved what’s called an “artificial pancreas,” a new type of device to monitor continuously a person’s blood glucose levels and release the hormone insulin at the right time and at the right dosage, much like the pancreas does in kids who don’t have T1D.

Researchers published last week in the New England Journal of Medicine [1] the results of the largest clinical trial yet of an artificial pancreas technology in small children, ages 2 to 6. The data showed that their Control-IQ technology was safe and effective over several weeks at controlling blood glucose levels in these children. In fact, the new device performed better than the current standard of care.

Two previous clinical trials of the Control-IQ technology had shown the same in older kids and adults, age 6 and up [2,3], and the latest clinical trial, one of the first in young kids, should provide the needed data for the U. S. Food and Drug Administration (FDA) to consider whether to extend the age range approved to use this artificial pancreas. The FDA earlier approved two other artificial pancreas devices—the MiniMed 770G and the Insulet Omnipod 5 systems—for use in children age 2 and older [4,5].

The Control-IQ clinical trial results are a culmination of more than a decade-long effort by the NIH’s National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and many others to create technologies, such as an artificial pancreas, to improve blood glucose control. The reason is managing blood glucose levels remains critical for the long-term health of people with T1D.

What exactly is an artificial pancreas? It consists of three fully integrated components: a glucose monitor, an insulin pump, and a computer algorithm that allows the other two components to communicate. This automation frees people with T1D from checking their blood glucose levels multiple times a day and from many insulin dosing decisions, though they still interact with the system at mealtimes.

Abdomen of a young child. A glucose sensor, attached to the skin sends a signal to an insulin pump which is hanging from the child's pants. A tube runs to a another adhesive on the abdomen to deliver insulin.

In this clinical trial, led by Marc D. Breton, University of Virginia School of Medicine, Charlottesville, researchers tested their Control-IQ technology (manufactured by Tandem Diabetes Care, San Diego, CA), also known as a hybrid closed-loop control system. Thanks to an algorithm developed at the University of Virginia Center for Diabetes Technology, insulin doses are administered automatically every few minutes based on readings from a continuous glucose monitor.

But treating younger children with T1D presents its own set of age-specific challenges. Younger kids generally require smaller doses of insulin more frequently. They also tend to have a more unpredictable schedule with lots of small snacks and random bursts of physical activity.

On top of all that, these young children have a tougher time than kids a few years older when it comes to understanding their own needs and letting the adults around them know when they need help. For all these reasons, young children with T1D tend to spend a greater proportion of time than older kids or adults do with blood glucose levels that are higher, or lower, than they should be. The hope was that the artificial pancreas might help to simplify things.

To find out, the trial enrolled 102 volunteers between ages 2 and 6. Sixty-eight were randomly assigned to receive the artificial pancreas, while the other 34 continued receiving insulin via either an insulin pump or multiple daily injections. The primary focus was on how long kids in each group spent in the target blood glucose range of 70 to 180 milligrams per deciliter, as measured using a continuous glucose monitor.

During the trial’s 13 weeks, participants in the artificial pancreas group spent approximately three more hours per day with their blood glucose in a healthy range compared to the standard care group. The greatest difference in blood glucose control was seen at night while the children should have been sleeping, from 10 p.m. to 6 a.m. During this important period, children with the artificial pancreas spent 18 percent more time in normal blood glucose range than the standard care group. That’s key because nighttime control is especially challenging to maintain in children with T1D.

Overall, the findings show benefits to young children similar to those seen previously in older kids. Those benefits also were observed in kids regardless of age, racial or ethnic group, parental education, or family income.

In the artificial pancreas group, there were two cases of severe hypoglycemia (low blood glucose) compared to one case in the other group. One child in the artificial pancreas group also developed diabetic ketoacidosis, a serious complication in which the body doesn’t have enough insulin. These incidents, while unfortunate, happened infrequently and at similar rates in the two groups.

Interestingly, the trial took place during the COVID-19 pandemic. As a result, much of the training on use of the artificial pancreas system took place virtually. Breton notes that the success of the artificial pancreas under these circumstances is an important finding, especially considering that many kids with T1D live in areas that are farther from endocrinologists or other specialists.

Even with these clinical trials now completed and a few devices on the market, there’s still more work to be done. The NIDDK has plans to host a meeting in the coming months to discuss next steps, including outstanding research questions and other priorities. It’s all very good news for people with T1D, including young kids and their families.

References:

[1] Trial of hybrid closed-loop control in young children with type 1 diabetes. Wadwa RP, Reed ZW, Buckingham BA, DeBoer MD, Ekhlaspour L, Forlenza GP, Schoelwer M, Lum J, Kollman C, Beck RW, Breton MD; PEDAP Trial Study Group. N Engl J Med. 2023 Mar 16;388(11):991-1001.

[2] A randomized trial of closed-loop control in children with type 1 diabetes. Breton MD, Kanapka LG, Beck RW, Ekhlaspour L, Forlenza GP, Cengiz E, Schoelwer M, Ruedy KJ, Jost E, Carria L, Emory E, Hsu LJ, Oliveri M, Kollman CC, Dokken BB, Weinzimer SA, DeBoer MD, Buckingham BA, Cherñavvsky D, Wadwa RP; iDCL Trial Research Group. N Engl J Med. 2020 Aug 27;383(9):836-845.

[3] Six-month randomized, multicenter trial of closed-loop control in type 1 diabetes. Brown SA, Kovatchev BP, Raghinaru D, Lum JW, Buckingham BA, Kudva YC, Laffel LM, Levy CJ, Pinsker JE, Wadwa RP, Dassau E, Doyle FJ 3rd, Anderson SM, Church MM, Dadlani V, Ekhlaspour L, Forlenza GP, Isganaitis E, Lam DW, Kollman C, Beck RW; N Engl J Med. 2019 Oct 31;381(18):1707-1717.

[4] MiniMed 770G System-P160017/S076. U. S. Food and Drug Administration, December 23, 2020.

[5] FDA authorizes Omnipod 5 for ages 2+ in children with type 1 diabetes . Juvenile Diabetes Research Foundation news release, August 22, 2022

Another Artificial Pancreas a Success in Tots With Type 1 Diabetes

Posted by

0


Kids ages 2 to 5 saw significant benefits with hybrid closed-loop system

A photo of the t:slim X2 insulin pump

Very young children with type 1 diabetes saw glycemic benefits when using a hybrid closed-loop system, the randomized PEDAP trial showed.

Among 102 children ages 2 to 5 years, the mean percentage of time that the glucose level was within the target range increased by 12.4 percentage points with the closed-loop system — also known as an artificial pancreas — versus standard of care by week 13 of follow-up (95% CI 9.5-15.3, P<0.001), reported Marc D. Breton, PhD, of the University of Virginia Center for Diabetes Technology in Charlottesville, and colleagues.

This was equivalent to about 3 hours more per day spent in the target range of 70 to 180 mg/dL, the group noted in the New England Journal of Medicineopens in a new tab or window.

In the closed-loop group, the mean percentage of time that the glucose level was within the target range increased from 56.7±18.0% at baseline to 69.3±11.1% during follow-up, while those receiving standard-of-care — consisting of either an insulin pump or multiple daily injections of insulin plus a continuous glucose monitor — went from spending 54.9±14.7% of time in range at baseline to 55.9±12.6% at week 13.

The benefits of the closed-loop system were evident within the first day of use and were maintained consistently throughout the trial, Breton’s group pointed out.

During the daytime (6 a.m. to 9:59 p.m.), the closed-loop group spent 67% of time in target range versus 56% in the standard-care group. At night (10 p.m. to 5:59 a.m.), time spent in range was 74% and 56%, respectively. The biggest between-group difference was at 5 a.m.

Compared with standard care, closed-loop users also spent significantly less time in hyperglycemia, with a mean difference of -5.4 percentage points (95% CI -7.3 to -3.6, P<0.001), and had significantly lower mean glucose levels (mean difference -17.7 mg/dL, 95% CI -23.2 to -12.2) and HbA1c levels (-0.42%, 95% CI -0.62 to -0.22).

There were no between-group differences when it came to time spent in hypoglycemia. Two cases of severe hypoglycemia occurred in the closed-loop group and one occurred in the standard-care group. There was also one case of diabetic ketoacidosis that occurred in the closed-loop group.

Overall, 48% of the closed-loop group achieved an HbA1c under 7%, as recommended by the American Diabetes Association, compared with only 30% of the standard-care group.

In an accompanying editorialopens in a new tab or window, Daniela Bruttomesso, MD, PhD, of the University of Padua in Italy, called it “remarkable” that 81% of all training for the closed-loop system was done virtually, as were 91% of all follow-up visits.

The researchers explained that the trial took place in the U.S. during the COVID-19 pandemic, which forced the research group to pivot away from face-to-face visits.

“Successful use of the closed-loop system under these conditions is an important finding that could affect the approach to initiating and monitoring the use of the closed-loop system and expand the use of such systems, particularly in patients living in areas without an endocrinologist but with reliable internet access,” Breton and team wrote.

Bruttomesso noted that a “virtual approach has several advantages over in-person visits, including a more relaxed environment, lower travel costs, and greater ease of contact with clinicians,” but “patient preferences, possible legal issues, and accessibility to technology (the families of the patients in this trial had above-average incomes) are all important considerations in choosing the most appropriate way to communicate with patients at the initiation of a closed-loop system or during routine follow-up.”

Bruttomesso instead recommended a mix of in-person and virtual clinic meetings with these very young patients to establish this diabetes management.

The 68 kids randomly assigned to the closed-loop group were fitted with Tandem Diabetes Care’s t:slim X2 insulin pump with Control-IQ Technology system. This system enables automated basal adjustments every 5 minutes and bolus corrections delivered from an insulin pump. The insulin pump was paired with a Dexcom G6 continuous glucose monitoropens in a new tab or window that sent glucose values to the pump.

The average age of PEDAP trial participants was 4 years, and baseline HbA1c was 7.6%. About 75% of patients were white, and the majority had an annual household income of $100,000 or more. At baseline, most were using an insulin pump but nearly none were using a continuous glucose monitoring system.

Currently, the insulin pump is FDA clearedopens in a new tab or window for adults and children ages 6 and up.

This isn’t the first hybrid closed-loop system to demonstrate success in this very young age group. Medtronic’s MiniMed 770G systemopens in a new tab or window was the first to be approved by the FDA for kids ages 2 to 6 years with type 1 diabetes, back in September 2020.

And in another similar trial, the KidsAP studyopens in a new tab or window published in the New England Journal of Medicine in early 2022, kids ages 1 to 7 spent a significantly longer time in target range with a closed-loop system. Here, kids were fitted with the Dana Diabecare RS insulin pump, the Dexcom G6 transmitter, and the CamAPS FX novel phone application, which ran an algorithm to predict glycemic control.

Artificial Pancreas Device May Help Folks With Type 2 Diabetes

Posted by

0


An artificial pancreas has long been considered the holy grail for people with type 1 diabetes, and new research suggests a more convenient version of this technology may help the millions of people living with type 2 diabetes.

Type 2 is the more common form of diabetes, and is closely linked to obesity.

The pancreas produces insulin, the hormone that helps blood sugar (or glucose) enter cells to be used as energy.People with type 1 diabetes make little to no insulin. When insulin is in short supply, glucose builds up, causing extreme fatigue, blurry vision, weight loss and confusion. Some people with type 2 diabetes also need to take daily insulin to keep their blood sugar in check.

Enter the artificial pancreas, an automated insulin delivery system that mimics the pancreas’ function.

“About 20% to 30% of people living with type 2 diabetes use insulin therapy to manage their diabetes, and we have shown that this way of delivering insulin with a closed-loop system is much more effective than their current insulin injections at reaching glucose targets,” said study author Dr. Charlotte Boughton, a clinical lecturer at the University of Cambridge in England.

With closed-loop systems for type 1 diabetes, the user enters information several times a day about the timing and size of their food intake, but insulin delivery between meals and overnight is automated. By contrast, the new system for people with type 2 diabetes is a fully closed loop. This means users don’t have to input any information.

It was developed using over-the-counter devices, including an off-the-shelf glucose monitor and an insulin pump with an app called CamAPS HX. This software predicts how much insulin is needed to keep blood sugar levels in the target range. People wear the blood sugar sensor and insulin pump and carry a smartphone with them for the system to work, Boughton said.

“This fully automated closed-loop system is a safe and much more effective way for people living with type 2 diabetes to manage their glucose levels than current standard treatment with insulin,” she said.

Just how effective was it? When people with type 2 diabetes used the new system, they spent twice as much time with glucose levels in the target range than when they tested blood sugar and gave themselves insulin shots, the investigators found.

Boughton said this is equivalent to an additional eight hours a day and was achieved without increasing the risk of dangerously low glucose levels.

“We anticipate that the improvement in glucose control we have seen may reduce the risk of diabetes complications such as eye disease, kidney disease and amputations, but a much larger study with longer follow-up is required to investigate this,” she added.

The new study included 26 people with type 2 diabetes. One group used the artificial pancreas for eight weeks and then switched to multiple daily insulin injections. The others were treated in the opposite order.

On average, people using the artificial pancreas were within their target blood sugar range two-thirds of the time. This is double what was seen with standard insulin shots, according to the report.

What’s more, people delivering insulin via shots spent two-thirds of their time with high glucose levels, compared with 33% when using the artificial pancreas, the researchers found.

The system also helped reduce levels of glycated hemoglobin, or HbA1c, which provides a snapshot of blood sugar levels over time.

No one in the study experienced dangerously low blood sugar, or hypoglycemia, which can occur if the device doesn’t keep blood sugar levels in the target range.

And then there is the quality-of-life improvement that comes with not needing to constantly check blood sugar levels, inject insulin or take medication. Nine of 10 participants said they spent less time managing their diabetes when they used the artificial pancreas.

This technology could be game-changing for millions.

“The number of people diagnosed with type 2 diabetes is increasing globally, and people are diagnosed at a younger age, so they are living with type 2 diabetes for longer,” Boughton said. “Anyone with type 2 diabetes who struggles to keep glucose levels where they should be with insulin injections could benefit from this system.”

The devices do cost more than standard insulin injections and glucose testing kits.

“If the closed-loop system can reduce the risk of very expensive diabetes complications in the long-term — such as the need for dialysis, visual impairment and amputations — then they may be cost-effective. But a much larger study with longer follow-up is required to investigate this,” Boughton stressed.

The researchers have previously shown that an artificial pancreas run by a similar algorithm is effective for those with type 1 diabetes and have also tested this system in people with type 2 diabetes who require kidney dialysis.

These systems can be fairly simple to use: You wear the devices, load them with insulin and go about your daily routine, explained Dr. John Buse, chief of endocrinology and director of the Diabetes Center at the University of North Carolina at Chapel Hill.

“No such device is available in the U.S. or, to my knowledge, anywhere in the world,” said Buse, who reviewed the new study.

Similar investigational technologies cost about $10,000 per year for the devices, supplies, insulin and provider support, he said. “[They cost] more in the first year with acquisition costs and less over time,” he explained.

More research is needed before this device is ready for prime time, but the promise is real, Buse added.

“Keeping glucose in a relatively narrow range holds the promise of reducing long-term complications of diabetes — blindness, kidney failure, amputations, heart attacks, strokes, as well as minimizing the risk of urgent hospitalization related to high or low glucose, as well as potentially reduced risk of infection, cognitive decline and other important issues common in diabetes,” he said.

Source: Nature Medicine.

No changes in glucose, insulin delivery during menstrual cycle with artificial pancreas

Posted by

0


A small group of women with type 1 diabetes using a hybrid closed-loop insulin delivery system maintained similar glycemic levels and insulin delivery throughout their entire menstrual cycle, according to study data

In findings published in Diabetes Technology and Therapeutics, a group of 16 women with type 1 diabetes had no significant changes in glycemic control during the luteal phase, menstrual phase and the rest of their menstrual cycle. The findings are the first step toward exploring the potential benefits of using a hybrid closed-loop system to optimize control in women struggling with glycemic control during certain phases of the menstrual cycle, according to Carol Levy, MD, clinical director of the Mount Sinai Diabetes Center.

Carol Levy, MD
Levy is clinical director of the Mount Sinai Diabetes Center.

“What’s been a challenge for clinicians is how to help manage patients who struggle with glycemic changes around the menstrual cycle and provide them guidance,” Levy told Healio. “This is a subanalysis of a larger study. We thought it would be interesting to see what insulin delivery and glycemic metrics we would get around the menstrual cycle. We took a small group of women within the larger study who agreed to do it. What we found was there weren’t marked changes with a hybrid closed-loop system.”

Levy and colleagues enrolled 16 menstruating women with type 1 diabetes from the International Diabetes Closed Loop trial to participate in a substudy (69% white, mean age, 31 years). Participants installed a tracking application on their personal phone to track menstrual cycle phases. All participants used a t:slim X2 insulin pump with Control-IQ technology (Tandem Diabetes Care) and the Dexcom G6 continuous glucose monitoring system. CGM metrics and insulin delivery during the mid-late luteal phase, menstrual phase and the rest of the menstrual cycle were analyzed for the cohort.

Data was reported for a mean of 145 days and six menstrual cycles. The cohort had a mean 24-hour glucose level of 161 mg/dL during the menstrual phase, 165 mg/dL during the luteal phase and 159 mg/dL during the rest of the cycle. Mean time in range was 69% in the menstrual phase, 67% during the luteal phase and 69% during the rest of the cycle.

Insulin delivery was unchanged during the menstrual cycle, with median basal rates remaining at 0.28 U/kg during all three phases. Median daily bolus insulin delivery rates were 0.31 U/kg during the luteal phase and 0.29 U/kg during the menstrual phase and rest of the cycle.

“What’s unique about this population is they were all well controlled because they were on the closed-loop system, so perhaps improved glycemic control may be able to blunt some of the disturbances [in insulin sensitivity] some women see during their menstrual cycle,” Levy said. “Women are also sometimes chasing these high blood sugars that they see around the menstrual cycle. The automated system may provide some benefit and not require much larger differences in insulin delivery, but we do not yet know all of the answers.”

Levy said future studies should focus on women who report having challenges maintaining a stable glycemic control throughout their menstrual cycle and analyze the effects of a hybrid closed-loop system.

“It may not even be that putting them on a closed-loop system will resolve their fluctuating glucose levels,” Levy said. “The closed-loop system with adjustments and other settings may really help them.”

Revolutionary ‘Artificial Pancreas’ Is Proving to Be Incredible For Type 1 Diabetics

Posted by

0


A new study on the efficiency of the so-called ‘artificial pancreas’ suggests it’s a huge leap in the right direction for people with diabetes who are in constant need of monitoring their blood glucose.

main article image

The technology works through a sort of closed loop system that monitors a person’s blood’s glucose while delivering doses of the right hormones – and for many this device is a dream come true.

In a systematic review of the evidence to date, a team led by researchers from the Aristotle University of Thessaloniki has evaluated 41 studies on the safety and efficacy of two types of artificial pancreas used by more than 1,000 volunteers.

The team found that volunteers trialling this class of device spent roughly 10 percent more time within a healthy range of blood glucose levels over any given 24 hour period.

That’s encouraging news, showing medicine is heading in the right direction, but more questions will need to be answered about balancing the risks, costs, and benefits of this amazing device.

Diabetes describes a class of conditions that make it difficult for the body to manage its sugar levels, either due to problems producing the insulin needed for cells to absorb glucose, such as type-1 diabetes, or resistance to insulin, like type-2.

This requires those with type-1 diabetes to check their blood levels and monitor their diet while potentially administering specially calculated doses of insulin.

While this sounds simple in principle, for millions of people this is a finicky task that can feel like balancing an egg in an earthquake, as a wide range of variables make it virtually impossible to maintain that perfect level of glucose.

Modern technology has helped in many ways, providing pumps that can accurately administer insulin and continuous monitoring devices that keep a careful minute-by-minute watch on blood glucose.

But these tools still require a human in between to make key judgements.

That’s what makes the ‘artificial pancreas’ tech so awesome – it aims to take the burden of decision making by having algorithms determine how much insulin or another balancing hormone called glucagon to inject in response to measurements of glucose in the blood.

While it’s not quite the same thing as a functional pancreas, for those with the condition it can reduce stress while providing some peace of mind at night.

A terrifying consequence of diabetes – especially among young people – is the risk of dying while asleep, possibly due to missing vital signs of critically low blood sugar.

It’s easy to see why many of those dealing with diabetes are keen to get their hands on this kind of tech, and this latest review shows it has potential to live up to its hype.

But the team conducting the research is also calling for higher quality studies – for example, none of the trials on young people with diabetes included children under five years old.

Three quarters of the trials evaluated were also just a week long, which provides limited information on the longer term effects of these closed-loop delivery systems.

What this means is we still have some way to go for artificial pancreas technology to conclusively prove its worth.

For policy makers, this is important stuff. New technology is often expensive, forcing many people to rely on insurance and government subsidies to afford these treatments.

If the evidence is scant on cost-benefit-ratios, only the wealthiest can afford that extra comfort. Importantly, without extensive studies, it’s possible some people with complications or slight variations in their condition might miss out on important caveats.

“Patients with particular problems, such as hypoglycaemia without warning symptoms, could benefit more,” says medical researcher Norman Waugh from the University of Warwick, whose commentary on the research calls for better studies.

“For children, we need data on parents’ quality of life. We need a trial of the dual insulin and glucagon system in cystic fibrosis related diabetes, where pancreatic and hepatic damage impairs responses to both hypoglycaemia and hyperglycaemia.”

Each year, research on this life-changing condition gives us hope of better ways to prevent, treat, or even cure diabetes.

We have every reason to celebrate the progress we make, but after the excitement dies down there is still a need to collect as much evidence as possible to make sure it really does live up to our expectations.

 

For all book lovers please visit my friend’s website.
URL: http://www.romancewithbooks.com

The Artificial Pancreas: What Is It and When’s It Coming?

Posted by

0


 

You’ve probably heard about the artificial pancreas, but are you up to speed on what’s happening in this rapidly evolving field?

First of All, What Is It Really?

The artificial pancreas (AP) is a device that mimics the blood sugar function of a healthy pancreas. It has three parts: a sensor for continuous glucose monitoring, a pump to deliver insulin, and a laptop or cell-phone component that directs the pump to deliver insulin as needed.

Most systems will deliver insulin alone, but some will be able to deliver both insulin and glucagon*.

How It’s Different from CGM

Artificial pancreas systems are often called “closed-loop” because they talk to both the sensor and the pump, bridging the gap between the two. The goal is to make a continuous loop without the need for human intervention. In testing so far, AP systems have often resulted in more time in target glucose ranges with less hypoglycemia, and they have also shined in controlling blood sugars overnight. They are not a cure by any means, but they are a huge improvement and will allow for diabetes management to go a little more on autopilot in the near future.

50 Years in the Making

The first precursors of the artificial pancreas date back to the 1970s. In the 50 years since, improvements have been made on all fronts: control algorithms are getting more predictive and less reactive, and pumps and glucose sensors are getting more accurate. Yet many challenges remain, such as the need for faster insulin, more stable glucagon, and systems that can work without user intervention, e.g., during meals and exercise.

The Future Is Almost Here

In June of 2017, Medtronic launched the first commercialized product, Minimed 670G.

The Medtronic device is a “hybrid” system due to the need to manually interact for meals and exercise. Hailed as a major advance towards a fully-automated artificial pancreas system, the 670G will be followed by other closed-loop systems in the coming months and years, with more and more academic group and industry collaborations being announced.

MiniMed 670G

One such effort – the IDCL (International Diabetes Closed Loop) Trial – is another example of the degree of collaboration between academic centers and industry. Led by the University of Virginia in conjunction with centers in Europe, companies like TypeZero Technologies, Tandem Diabetes Care, Dexcom and Roche Diagnostics are also involved. Other companies like Insulet (Omnipod) and Bigfoot are developing AP systems as well.

If You Just Can’t Wait

Alongside conventional development of AP systems, “Do It Yourself” or DIY movements spearheaded by patient and engineering communities are gaining visibility with a reported 400+ PWD currently using DIY artificial pancreas systems. Initiatives such as DIYPS.org and #wearenotwaiting are providing information on the internet to help people with diabetes build their own AP systems using commercially available CGM and pumps while providing information on how to set up control algorithms.

These systems require a great deal of user learning and commitment. While probably not for everyone and regulatory authorities sending out caveats on the potential risks involved, they can be a way for people to access artificial pancreas technology now before other systems are cleared for use.

At the 2017 Taking Control Of Your Diabetes Conference & Health Fair in San Diego, there was a panel discussion with five people who experimented with DIY systems and shared their thoughts, advice, and personal experiences.  You can watch the seminar and hear what they had to say here.

As a result, we can expect several artificial pancreas options in the coming years, which is amazing news! Systems will differ, but the goal will be the same: to reduce the burden of living with diabetes until a cure is found. We look forward to seeing more and more options in this space, and send kudos to all involved for their perseverance, passion, and commitment!

*Glucagon causes the liver to release stored glucose, raising blood sugar levels. It can be used to treat severe hypoglycemia.

Automated Insulin Delivery (Artificial Pancreas, Closed Loop)

Posted by

0


artifiical pancreas

 

The development of automated insulin delivery has many names – artificial pancreas, hybrid closed loop, Bionic Pancreas, predictive low glucose suspend – but all share the same goal: using continuous glucose monitors (CGMs) and smart algorithms that decide how much insulin to deliver via pump. The goal of these products is to reduce/eliminate hypoglycemia, improve time-in-range, and reduce hyperglycemia – especially overnight.

See below for an overview of the automated insulin delivery field, focused on companies working to get products approved. Do-it-yourself automated insulin delivery systems like OpenAPS and Loop are not included here, though they are currently available and used by a growing number of motivated, curious users.

We’ve also included helpful links to articles on specific product and research updates, as well as some key questions.

Who is Closing the Loop and How Fast Are They Moving?

Below we include a list of organizations working to bring automated insulin delivery products to market – this includes their most recently announced public plans for pivotal studies, FDA submissions, and commercial launch. The organizations are ordered from shortest to longest time to a pivotal study, though these are subject to change. This list excludes those without a commercial path to market (e.g., academic groups). The first table focuses on the US, with European-only systems listed in the second table.

Updated: November 4, 2017

US Products

Company / Organization Product Latest Timing in the US
Medtronic MiniMed 670G/Guardian Sensor 3 – hybrid closed loop that automates basal insulin delivery (still requires meal boluses) FDA-approved and currently launching this fall to ~35,000 Priority Access Program participants in the US. Pump shipments to non-Priority Access customers will start in October, with sensors and transmitters to ship by the end of 2017 or early 2018. Medtronic is experiencing a global CGM sensor shortage that won’t resolve until spring 2018.
Tandem t:slim X2 pump with built-in predictive low glucose suspend (PLGS) algorithm; Dexcom G5 CGM

t:slim X2 pump with built-in Hypoglycemia-Hyperglycemia Minimizer algorithm; Dexcom G6 CGM (including automatic correction boluses)

 Launch expected in summer 2018. Pivotal trial now underway, with FDA submission expected in early 2018.

Launch expected in the first half of 2019. Pivotal trial to begin in the first half of 2018.
Insulet OmniPod Horizon: pod with built-in Bluetooth and embedded hybrid closed loop algorithm, Dash touchscreen handheld, and Dexcom G6 CGM

User will remain in closed loop even when Dash handheld is out of range

 Launch by end of 2019 or early 2020, with a pivotal study in 2018
Bigfoot Biomedical Smartphone app, insulin pump (acquired from Asante), and a next-gen version of Abbott’s FreeStyle Libre CGM sensor (continuous communication)

The smartphone is expected to serve as the window to the system and complete user interface

 Launch possible in 2020, with a pivotal trial expected in 2018
Beta Bionics Bionic Pancreas iLet device: dual chambered pump with built-in algorithm; hybrid or fully closed loop; insulin-only or insulin+glucagon; custom infusion set, Dexcom CGM

Likely to launch as insulin-only product, with glucagon to be optionally added later

Currently using Zealand’s pumpable glucagon analog

 Insulin-only: possible US launch in the first half of 2020, with a pivotal trial to start in the beginning of 2019.

Insulin+glucagon (bihormonal) pivotal trial expected to start in the beginning of 2019. Timing of FDA submission and launch depend on a stable glucagon, among other things.

European Products

Company / Organization Product Latest Timing in Europe
Medtronic MiniMed 640G/Enlite Enhanced – predictive low glucose management

MiniMed 670G/Guardian Sensor 3 – hybrid closed loop that automates basal insulin delivery (still requires meal boluses)

 Currently available in Europe

No timing recently shared. Approval was previously expected in summer 2017
Diabeloop Diabeloop algorithm running on a wireless handheld, Cellnovo patch pump, Dexcom CGM Pivotal trial expected to complete in February/March 2018. Possible European launch in 2018
Roche, Sensonics, TypeZero Will use Senseonics’ 180-day CGM sensor, Roche pump and TypeZero algorithm Pivotal trial expected to begin in Europe in early 2018
Cellnovo, TypeZero Cellnovo patch pump with integrated TypeZero algorithm; presumably a Dexcom CGM Aims for a 2018 European launch. No pivotal trial details shared

Helpful Links

Medtronic: MiniMed 670G

Tandem

Insulet

Bigfoot

Beta Bionics

Test Drives:

test drive – UVA’s Overnight Closed-Loop Makes for Great Dreams. Kelly participates in UVA’s overnight closed loop trial and reports back on an incredible opportunity for the field to move fast, reduce anxiety, and beat timelines.

test drive – Kelly and Adam take UVA’s DiAs artificial pancreas system home 24/7 for a three-month study. Their key takeaways, surprises, and next steps.

Key Questions for the Artificial Pancreas

Are patient expectations too high? If we expect too much out of first-generation artificial pancreas systems – e.g., “I don’t have to do anything to get a 6.5% A1c with no hypoglycemia” – we might be disappointed. Like any new product, early versions of the artificial pancreas are going to have their glitches and shortcomings. Undoubtedly, things will improve markedly over time as algorithms advance, devices get more accurate and smaller, insulin gets faster, infusion sets improve, and we all get more experience with automated insulin delivery. But it takes patience and persistence to weather the early generations to get to the truly breakthrough products. We would not have today’s small insulin pumps without the first backpack-sized insulin pump; we would not have today’s CGM without the Dexcom STS, Medtronic Gold, and GlucoWatch; we would not be walking around with smartphones were it not for the first brick-sized cellphones. Our research trial experience with automated insulin delivery recalibrated our expectations a bit – these systems are going to be an absolutely terrific advance for many patients, but they will not replace everything out of the gate. Let’s all remember that devices need to walk first, then run, and it’s okay if the first systems are more conservative from a safety perspective.

What fraction of patients will be willing to wear some type of automated insulin delivery system? Right now, many estimate that ~30% of US type 1’s wear a pump, and about 15% to 20% wear CGM. There are a lot of reasons why that may be the case, including cost, hassle, no perceived benefit, no desire to switch from current therapy, wearing a device on the body, alarm fatigue, etc. Will automated insulin delivery address enough of these challenges to expand the market?

Will healthcare providers embrace automated insulin delivery? Today, healthcare providers lose money when they prescribe pumps and CGM – they are very time consuming to train, prescribe, and obtain reimbursement for. We need to make sure that automated insulin delivery systems make providers’ lives easier, not more complicated.

Will there be a thriving commercial environment and reimbursement? It’s extremely expensive to develop and test closed-loop systems, and companies will only develop them if there is a commercial environment that supports a reasonable business. Reimbursement is a major part of that, and it’s hard to know if insurance companies will pay for closed-loop systems for a wide population of patients. We are optimistic that reimbursement will be there, especially if systems can simultaneously lower A1c, reduce hypoglycemia, and improve time-in-range.

What’s the right balance between automation and human manual input? The holy grail is a fully-automated, reactive closed loop that requires no meal or exercise input. But insulin needs to get faster to make that a reality. For now, daytime systems need to deal with balancing human input with automation, and there’s an associated patient learning curve. How much should automated insulin delivery systems ask patients to do? How do we ensure patients do not forget how to manage their diabetes (“de-skilling”) as systems grow in their automation abilities?

Insulin-only or insulin+glucagon? Ultimately, we believe that the question is partially one of patient preferences. There will be some patients who may want the extra glycemic control offered by the dual-hormone approach and will be willing to accept a bit more risk or a more aggressive algorithm. An insulin+glucagon system could be helpful for those with hypoglycemia unawareness, and if such a system makes it to the market, some patients will certainly want to give it a try. We believe a range of options is a good thing for people with diabetes, since all systems and products have pros and cons. Ultimately, cost considerations may present the largest factor in adoption. An insulin+glucagon system certainly brings multiple cost elements to consider – a second hormone, a dual-chambered pump, custom infusion sets, potentially higher training, etc. It’s hard to know at this point how the relative costs/benefits will exactly compare to insulin-only systems.

The FDA Just Approved the Artificial Pancreas.

Posted by

0


We are always excited about new technology and medical breakthroughs, but this is some of the most exciting news we’ve heard in a while! On Wednesday, September 28th, the FDA approved the first automated insulin delivery device, or “artificial pancreas.”

Why is this news so great? Well, this first-of-its-kind technology allows people with type 1 diabetes to experience a greater degree of freedom by offering continuous monitoring of their glucose levels. This task is currently a 24-7 responsibility required of patients with type 1, but with the new artificial pancreas, the individual would only be required to manually administer insulin after meals and to alert the device when they are exercising.

This incredible device is projected to become available in the Spring of 2017, and we couldn’t be more thrilled!

Watch the video. URL:https://youtu.be/HLDB4-zdMFs

Source: thediabetessite.com

The FDA just approved the first ‘artificial pancreas’

Posted by

0


The FDA just approved a device that’s often referred to as an “artificial pancreas.”

The device, made by Medtronic, is called the MiniMed 670G. It’s been approved for people with type 1 diabetes over the age of 14. It works by automatically monitoring a person’s blood sugar levels and administering insulin as needed – no constant checking and injecting required.

insulin pump diabetes

Diabetes is a condition in which people have a hard time processing sugar. Type 1, in particular, is an autoimmune disease in which the body mistakenly kills cells that are supposed to make insulin, a hormone that helps people absorb and process the sugar in food.

Insulin is produced and released through the pancreas – that’s where the term “artificial pancreas” comes in.

Roughly 1.25 million people in the US have Type 1 diabetes. These patients often opt to have an insulin pump that can administer insulin as needed throughout the day. Some also buy a glucose monitor, which is used to continuously monitor blood sugar levels; that way a diabetic can know if their levels are going too low or too high and find a way to correct it.

In contrast, the MiniMed 670G, referred to as a “hybrid closed loop” system, is what Jeffrey Shoorin of the FDA said in a statement is a “first-of-its-kind technology”: the first approved system that combines both the glucose monitor and the insulin pump in one device.

According to the FDA, the device measures blood sugar every five minutes, then responds by sending insulin into the body, or holding steady. Diabetics can also manually request insulin around mealtimes.

A clinical trial of the MiniMed 670G involving 123 people with type 1 diabetes had no serious adverse events, though the FDA notes that “risks may include hypoglycemia, hyperglycemia, as well as skin irritation or redness around the device’s infusion patch.”

While the device is approved as of today, Medtronic will do additional testing to see how well it works in real-life situations. The company is also conducting additional trials to see if it can be used in children 7 to 14 years old.

“We are committed to preparing for commercial launch as quickly as possible,” Francine Kaufman, M.D., chief medical officer of the Diabetes Group at Medtronic, said in a statement.

artificial pancreas