TouchENDOCRINOLOGY coverage of data presented at EASD 2024:
The latest clinical evidence surrounding the MiniMed 780G system focuses on expanding its access to younger children with type 1 diabetes. The hope is that by extending its use to children aged 2-6 years, its automated insulin delivery could significantly reduce the burden of diabetes management for families.
The LENNY trial (NCT05574062) aimed to evaluate the safety and effectiveness of the MiniMed 780G system (MM780G) in these very young children. The results were presented at EASD 2024, and in this interview, we spoke with the study’s investigator, Prof. Tadej Battelino (University Medical Center Ljubljana, Ljubljana, Slovenia), to explore the key findings and how this technology could transform diabetes management for young children.
Associated abstract:
Battelino T et al. The LENNY randomised crossover trial demonstrates the MiniMed 780G system is safe and effective for children aged 2-6. Abstract LBA36. EASD 2024
Questions:
- Why was the 2–6 year age group with type 1 diabetes chosen as the focus of the LENNY trial?
- Could you provide a brief overview of the study’s design, highlighting the key endpoints and the methods used to monitor safety?
- What were the key efficacy findings and safety outcomes in this very young population?
- How do you see the MiniMed 780G system potentially transforming diabetes management for very young children?
- What are the next steps in the clinical development of the MiniMed 780G for this population?
Disclosures: Prof. Tadej Battelino discloses receiving grant/research support from Novo Nordisk, Sanofi, and Medtronic; serving on the advisory boards for Novo Nordisk, Eli Lilly, Sanofi, Dexcom, Abbott and Medtronic; and participating in the Speaker’s Bureau for Novo Nordisk, Eli Lilly, Sanofi, Dexcom, Abbott and Medtronic.
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Transcript:
Q: Why was the 2–6 year age group with type 1 diabetes chosen as the focus of the LENNY trial?
The group of pre-school children aged two to six years is likely one of the most vulnerable populations with type 1 diabetes. And at the moment, they have little choice on how to treat their disease. There are choices. There are some options, but they are limited. And most certainly, with the advanced hybrid closed-loop 780G, the data were actually published only from two individual centres, but there was no randomized controlled multicentre trial.
Additionally, there is data showing that high glucose is damaging the brain of this population. So we thought we really need a trial demonstrating that we can reduce the high glucose and put these children closer to the normal glucose and thus preserve their brains.
Q: Could you provide a brief overview of the study’s design, highlighting the key endpoints and the methods used to monitor safety?
So the design was quite simple and standard for a device trial. So it was randomization to the sequence, either using the advanced hybrid closed-loop or using the manual pump and sensor, but also in this control group with manual pump and sensor, the predictive hypo suspension algorithm was active. So even these pre-school children in the control group were actually safeguarded by the technology. We thought this was fair that, you know, we do not expose them to something that is dangerous, having something in existence that they could use.
Additionally, of course, when using the advanced hybrid closed-loop, we were very careful with the settings. So we initially used the higher target for the system so that we would prevent hypoglycaemia. And then if this worked well, we gradually decreased the target that the automated we gradually decreased the target that the automated system used to manage glycaemia.
So in this randomized trial, 98 young pre-school children were included and randomized to the sequence either advanced hybrid closed-loop control, which was a set manual pump plus predictive low glucose suspend or vice versa. Interestingly enough, 96 out of these 98 completed the trial, which is an extraordinarily high retention in the trial.
Obviously, for the final analysis, it was a intent-to-treat so all 98 were included to get the final results.
Q: What were the key efficacy findings and safety outcomes in this very young population?
So the primary outcome was time in range defined as between 70-180 mg/dL or 3.9-10 mmol/L. This is the standard as per international consensus.And this was increased if you calculated the mean average difference in between the manual with the predictive suspend and advanced hybrid closed-loop of almost 10 percent, 9.9 exactly, increasing time in range with the use of the advanced hybrid closed-loop 780G.
In addition, this was all within the tight range. So most of the benefit even was in the range in between 70-140 or 3.9-7.8, which was something that we did not expect and were particularly happy about. There was a slight increase in the range below 70, but no increase in the range below 54. So we thought that the outcome was also from the safety side, satisfactory.
Additionally, we checked, of course, for the major events. So there were no severe hypoglycaemia throughout the duration of the trial in any of the study arms. There was one ketoacidosis in the advanced hybrid closed-loop user due to a viral diarrhoea that was resolved in a day. So it looked like that from the efficacy part, so a very significant increase in time in range of 10 percent with no very important increase in time below range, particularly not on the dangerous rate below 54 or 3.9. No severe hypoglycaemia.
So it looks like that the system works. Of course, only children that used more than six units per day were including due to [systems] inherent capability to go down to these six units.
Q: How do you see the MiniMed 780G system potentially transforming diabetes management for very young children?
But based on the data that we see from the diabetes management part, and the data we see from the safety, we were interested in another part of the story, which to me, perhaps, in a way, is at least as important. And this the satisfaction of the families, and the users.
So interestingly, there was an increase in sleep quality in many, many parts for the parents. And we know it, because having a pre-school child with type 1 diabetes, you have to take care for the nights to avoid hypoglycaemia, to avoid very high glucose. This is done now by the algorithm. So we were very happy to see that this is really seen in the quality of sleep questionnaire as well as fear of hypoglycaemia improved.
So we were very happy that this 780G actually is safe for the population of pre-school children in between two and six that use more than six units of insulin a day, total daily dose. And, also, that the users, the community, the family, these units that are helping this little child are actually happy, benefited as well. So it looks like that it will transform considerably the options these families will have to treat the disease of the pre-school child.
I think in the societies we live in, parenting is becoming an increasing challenge to start with. It is a very dynamic world. It’s a bit confused, perhaps. Some people would say there are much less standards to stand by perhaps. So it’s challenging. If a very, very difficult chronic disease that needs, like, continuous attention to a parameter of your body that used to be automated by the nature and is then lost, of course, adds considerable stress and burden to this family. If we can alleviate this burden with an automated algorithm that basically takes part of this care over, of course, is a major help to the entire little community, family, that takes care of this child. And the results of the 780G trial, nicknamed LENNY because of the little lion that was with them, actually demonstrates that this is the case, that the 780G algorithm and system can help the little individual and the family actually manage diabetes more efficiently, save, and also perhaps with less burden.
Q. What are the next steps in the clinical development of the MiniMed 780G for this population?
So quite obviously, being happy with the current results, we do want more. It’s in the human nature.
So we would love to have a system that will not be hybrid anymore. That will be completely automated. And for this, we need a faster insulin, that is under development, and an adjusted algorithm to this that will perhaps allow us to go even more within the tight glycaemic range to even more protect the brain of these young individuals and, obviously, to protect them from the chronic complications of diabetes.
So the hopes are very high, and there are also initial results that show that perhaps this hope will become a reality not so far from now.
Interviewer/Editor: Gina Furnival
Cite: Battelino T. MinMed 780G safe and effective for children 2-6 years with type 1 diabetes . touchENDOCRINOLOGY. September 16, 2024.
