From healio.com/news
Key takeaways:
- Diabetes technologies have been evolving rapidly in recent years and now serve a wide range of patients.
- Usage is up for technologies such as automated insulin delivery and continuous glucose monitoring.
The evolution of diabetes technologies has led to the expansion of automated insulin delivery for type 2 diabetes, continuous glucose monitoring for people without diabetes and calls for a higher standard of care in type 1 diabetes.
The American Diabetes Association Standards of Care for 2025 states CGM should be offered to all people with diabetes who use any insulin therapy. Now, diabetes technology for insulin-treated diabetes is going beyond CGM. The FDA cleared the Omnipod 5 automated insulin delivery system (Insulet) in August and the Control IQ+ (Tandem) in March for adults with type 2 diabetes based on data that show the devices could provide glycaemic benefits.
“Unfortunately, with the natural progression of type 2 diabetes, many end up needing insulin,” Diana Isaacs, PharmD, BCPS, BCACP, BC-ADM, CDCES, FADCES, FCCP, endocrine clinical pharmacy specialist and co-director of endocrine disorders in pregnancy at Cleveland Clinic Endocrinology & Metabolism Institute and a Healio | Endocrine Today Editorial Board Member, said in an interview. “Asking someone to take multiple [insulin] injections per day is really challenging, so being able to offer an insulin pump and, specifically, an automated insulin delivery system that really improves time in range and reduces HbA1c similar to what we see in type 1 diabetes ... is a big deal.”
In the past year, several over-the-counter CGMs have been approved, some of which are available for people without diabetes. Carol J. Levy, MD, CDCES, professor in the department of medicine and department of obstetrics, gynecology and reproductive science and director of the Mount Sinai Diabetes Center and associate system chief of endocrine clinical research, said OTC CGMs may fill a niche by providing access to diabetes technology for people lacking insurance coverage.
“These provide an option for those individuals who wish to have some feedback and can afford them,” Levy told Healio | Endocrine Today.
Progress is also being made with automated insulin delivery systems in type 1 diabetes. Viral N. Shah, MD, professor of medicine in the division of endocrinology and metabolism and director of diabetes clinical research at Indiana University Center for Diabetes and Metabolic Diseases, said many health care professionals are excited for the launch of the twiist automated insulin delivery system (Sequel), which will be the first system in the U.S. using the algorithm that was developed by the open-source community and later commercialized by Tidepool.
“The algorithm is different compared to other automated insulin delivery systems,” Shah told Healio | Endocrine Today. “Having a lot of options would be good for people to select the appropriate technology for them.”
Advances in automated insulin delivery have led some researchers to issue a call to action for people with type 1 diabetes. A commentary published in Diabetes Technology & Therapeutics in February stated, “All people with type 1 diabetes and other patients with insulin-dependent diabetes must be given a choice to use an automated insulin delivery system at the time of diagnosis or as soon after diagnosis as possible.”
“Algorithms have come a long way. Sensors have come a long way,” Satish K. Garg, MD, professor of medicine and pediatrics at the Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus and an author on the report, told Healio | Endocrine Today. “[The commentary was intended] to bring people up to date with where we have come in the past 15 to 20 years in this whole pathway of CGMs and [insulin] pumps, and integrating the two.”
Advances for type 2 diabetes
Two trials published earlier this year showed automated insulin delivery can not only benefit people with type 1 diabetes, but also those with insulin-treated type 2 diabetes.
In the single-arm SECURE-T2D trial, adults with type 2 diabetes on insulin therapy used the Omnipod 5 automated insulin delivery system for 13 weeks. This group had a decline in HbA1c from 8.2% at baseline to 7.4% at 13 weeks.
Automated insulin delivery also improved glycemic control in the 2IQP trial. Investigators randomly assigned adults with type 2 diabetes 2:1 to use the t:slim X2 insulin pump (Tandem) with Control-IQ+ automated insulin delivery system with the Dexcom G6 CGM or the Dexcom G6 alone for 13 weeks.
Adults who used automated insulin delivery had a 0.9 percentage point decline in HbA1c from baseline to 13 weeks vs. a 0.3 percentage point decline for those who used CGM alone (P < .001). Time in range increased from 48% at baseline to 64% at 13 weeks with automated insulin delivery.
Based on findings from both trials, the Omnipod 5 and Control IQ+ were cleared by the FDA for use by adults with type 2 diabetes.
Shah, who was an investigator on the SECURE-T2D trial, said the recent approvals have already made an impact on clinical practice.
“A lot of people with type 2 diabetes, particularly on basal insulin only, are seen by primary care,” Shah said. “I doubt the use of automated insulin delivery systems is high in primary care practice. These studies and FDA approval will help train primary care physicians and hopefully encourage them to use this technology more.”
Levy said the availability of multiple systems will allow health care professionals to prescribe a device that works best for each individual’s needs.
“These are two different systems that both have different, unique niches for patients: one is tubeless and one provides autocorrection boluses,” Levy said. “Each has unique advantages and opportunities for people with type 2 diabetes.”
A role for OTC devices
Several OTC CGMs have earned FDA clearance since the beginning of 2024. In March 2024, FDA cleared a glucose biosensor system (Stelo, Dexcom) for all adults who do not use insulin, including those without diabetes. In June 2024, the FreeStyle Libre Rio and Lingo (Abbott) were cleared by the FDA; Libre Rio is indicated for adults with type 2 diabetes and Lingo was cleared for those without diabetes looking to improve overall health and wellness.
Though OTC CGMs can help increase access to diabetes technology for people without insurance coverage, Levy said cost may still be a barrier for some. Lingo and Stelo are both offered at a price of $89 for two sensors, which would last for a combined 30 days, according to product information on both websites.
Shah said OTC CGMs offer valuable information, but there is limited data on whether the devices lead to improved outcomes in any populations.
“I have a lot of patients who have used an OTC CGM,” Shah said. “Either they have prediabetes or no diabetes. [In those populations], it is good to see that information and make some changes. But there are many questions that remain.”
Shah said research on whether OTC CGMs can benefit people with or at risk for prediabetes is needed, including how often they should wear the CGM, the optimal interval of wear time and whether adults should wear a sensor intermittently or continuously.
Despite including several interesting features, Isaacs said uptake of OTC CGMs appears to be slow.
“I don’t think it’s as high as the companies would have liked or expected, and in some ways, I’m not surprised,” Isaacs said. “I don’t think you need to wear [an OTC CGM] all the time to learn from it.”
Improvements in insurance coverage of prescription CGMs is one reason the OTC devices have not taken off, and another factor is access to devices, Isaacs added.
“Right now, [the OTC CGMs] are not available in pharmacies; you have to purchase them online,” Isaacs said. “They both have respective websites. I think if they were available in pharmacies, that would probably increase the access a little bit more.”
Limited options for type 1 diabetes in pregnancy
Managing type 1 diabetes during pregnancy requires target glucose ranges that are lower than most devices offer. In May 2024, the FDA approved the CamAPS FX closed-loop algorithm (CamDiab) as the first one for pregnant women with type 1 diabetes. However, the algorithm is still unavailable for use in the U.S. The CamAPS FX algorithm is compatible with the mylife YpsoPump (Ypsomed), which the FDA has not yet approved.
“It is very frustrating for those of us who work in the pregnancy space, because even our guidelines [state] you should use a pump that has an algorithm approved for use in pregnancy,” Issacs said. “We don’t have one, so it’s really tough.”
The CRISTAL trial showed that a currently available automated insulin delivery system could benefit pregnant women with type 1 diabetes. Researchers for this trial randomly assigned pregnant women with type 1 diabetes to use the Medtronic 780G automated insulin delivery system or receive standard of care with either multiple daily insulin injections or insulin pump therapy. Researchers found similar improvements in time in range between the two groups. The automated insulin delivery group had a significantly lower time below range compared with the standard of care group.
The Medtronic 780G was not designed with pregnancy in mind, as the lowest target glucose that can be set on the device is 100 mg/dL, Levy said. While this is a lower target than for other devices, the ADA Standards of Care recommends pregnant women with diabetes aim for a target glucose of less than 100 mg/dL before meals, as well as during bedtime and overnight.
Additionally, Levy said while the CRISTAL trial did not find the Medtronic 780G to be superior to standard of care for many it did reduce self-care burden.
“Many individuals, however, needed to use entry of fake carbohydrates and other assistive techniques to improve glucose control,” Levy said. “This type of off label use at present is the only option for those pregnant individuals using a commercially available automated insulin delivery system in the U.S. at present.”
A call to action
Diabetes technology continues to advance, but many people with type 1 diabetes still lack access to automated insulin delivery systems, Garg said. A call-to-action paper published in Diabetes Technology & Therapeutics listed four recommendations for future automated insulin delivery guidance. The recommendations stated all people with type 1 diabetes and insulin-treated diabetes should be given the choice to use automated insulin delivery, and the choice should be based on everyone’s situation and need. Additionally, there should be documentation in a patient’s medical record if they are not offered automated insulin delivery, and national health care systems should prioritize providing “unfettered access” to automated insulin delivery systems.
“Cost remains a barrier,” Garg said. “Resources remain a barrier, affordability [remains a barrier], and whether [health systems] have the infrastructure to support people going on automated insulin delivery.”
Garg said many people with type 1 diabetes also do not have access to an endocrinologist, and primary care physicians may lack adequate training to initiate and support patients who use automated insulin delivery systems.
“[Primary care providers] don’t have time to put [a patient] on a pump,” Garg said. “They may not have the capability of downloading data and putting it in the electronic medical record. All those things are very time-consuming. Resource utilization is not available in those practices, even in the U.S.”
Isaacs said the diabetes community generally needs to do a better job making sure all patients with insulin-treated diabetes are offered automated insulin delivery access.
“We are in a new era,” Isaacs said. “Years ago, we would make people prove that they could earn an insulin pump, prove that they had good carbohydrate counting, prove that they could get their HbA1c to a certain level prior to starting one. Now, the technology is so much better. It’s clear that the benefits far outweigh the risks, and we don’t want to put up unnecessary barriers to accessing these systems.”
Looking ahead
Health care professionals look forward to more novel diabetes devices in the coming year. Isaacs called attention to the launch of the twiist automated insulin delivery system, which is scheduled for the second quarter of 2025. The system received FDA clearance in March 2024. In April, Sequel Med Tech announced twiist would be compatible with the Eversense 365 integrated CGM (Senseonics), a CGM with an implantable sensor that lasts for up to 1 year.
The Omnipod is currently the only FDA-approved tubeless insulin pump, but Isaacs said she expects more companies to unveil tubeless insulin pumps in the coming years.
Continuous ketone monitoring is also on the horizon. Garg said companies are working on developing dual CGM and continuous ketone monitors that could give people with diabetes more data to manage their disease.
“Dual CGM and continuous ketone monitors are going to change the way we manage diabetes,” Garg said.
One area of research that will be spotlighted in the months ahead is the use of GLP-1 receptor agonists as adjunctive therapy for people with type 1 and type 2 diabetes. Shah was the lead author on a consensus report on GLP-1s as an adjunctive therapy for automated insulin delivery in type 1 diabetes. The report detailed 31 recommendations and concluded GLP-1s could have a role in improving glycemic control without increasing the risk for hypoglycemia or DKA.
“It makes sense, both theoretically and scientifically, that GLP-1s would help people lose weight, improve the metabolic and glycemic outcomes, and could synergize the automated insulin delivery system,” Shah said.
Levy said large studies investigating GLP-1 use with automated insulin delivery are needed.
“As clinicians, we are struggling at times managing patients using algorithms without formal approval and formal data supporting methods to adapt and utilize these systems in situations with limited data,” Levy said.
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