Another artificial pancreas project has joined the race for approval in Europe – and it could be more advanced than available systems. The French group Diabeloop has started a CE mark trial for its handset, which it is developing in partnership with two other companies, Dexcom and Cellnovo.
“We know from results presented that our system is more efficient than others. With our artificial pancreas the patient doesn’t need to do anything on the handset – the device has total control of delivery of insulin,” Marc Julien, Diabeloop’s managing director, tells EP Vantage.
Where Dexcom makes the continuous glucose monitor (CGM) used in the system and Cellnovo the wearable insulin pump – both devices are already CE marked separately – Diabeloop’s speciality is software. It has developed several algorithms to automatically calculate and deliver the correct insulin dose based on data from the glucose monitor, and while the patient can use a handset to control the system, minimal involvement is needed.
“What we’re CE marking is the three components working together,” Mr Julien says. For this it will have to demonstrate the complete system in the clinic. The trial will enrol 60 patients and will compare the Diabeloop system to other insulin pumps used with a CGM; in the control arm patients will follow the usual procedure of programming the pump themselves, calculating the quantity of insulin based on readings from the glucose sensor.
The three-month crossover design ought to allow the company to prove a statistically significant improvement in time in tight glycaemic range – that is, with blood glucose between 70-180mg/dl – the number of hypoglycaemic events, and average blood glucose levels. All these endpoints have been hit in previous trials of the system, Mr Julien says.
Data from the new trial ought to appear before the end of this year, and if positive European approval should follow in 2018. The challenge then will be reimbursement.
“For that we will need to have a much longer trial,” says Mr Julien. Reimbursement of CGMs in Europe is patchy: the UK NHS does not routinely cover them, but Dexcom won German reimbursement for some of its devices last year and two days ago Abbott said its FreeStyle Libre monitor will be reimbursed in France.
Diabeloop, like all artificial pancreas developers, will need to prove the long term economic benefits of the system over the current human-mediated CGM-and-pump paradigm in order to win broad reimbursement. The company has not yet begun to think about pricing – “we need to discuss that with the payers and we are still looking into that,” says Mr Julien – and this will have to be carefully judged.
In the longer term, the group has ambitions to break America, though it will only start moving west once its artificial pancreas system is established on the European market. It also wants to develop different versions of its product, and it is possible that other partnerships could be on the cards in future.
“Distinct groups of people need different kinds of solutions because of their specific illness – for example children or patients with very severe diabetes. For these two groups of patients we are also looking at providing them with adaptive solutions,” Mr Julien says, though he points out that for now Diabeloop is only looking at the system for adults with type 1 diabetes.
So far Diabeloop has been funded by the French government’s research institution CEA-LETI and by CERITD, a non-profit trust focusing on diabetes R&D. CERITD remains Diabeloop’s main shareholder, Mr Julien says.
With a new trial in the offing the group is currently raising more money from VCs, and hopes to close the round “in the near future”.
This financing will enable the company to do three things: CE mark the current system, launch it in Europe, and begin work on a next-generation version that will include new features. “That should keep us working for a good year and a half to two years,” Mr Julien says. After that the group will need more cash for further development its system, and to enable it to go after US approval.
“That’s our medium-term view – for a start-up it’s still quite far away,” says Mr Julien. The next step on this road will be success in the coming CE mark trial.