Report
Teaser, summary, work performed and final results
Periodic Reporting for period 1 - DiaMOND (personalised Diabetes Management using lOw-cost Needle-free multiple-biomarkers monitoring Device)
Teaser
\"Diabetes is the #1 health challenge of the 21st century. Continuous Glucose Monitoring or CGM ($1.25B market in 2016, growing 29%/yr) is today’s cornerstone of “diabetes self-management†and the most effective solution to reduce the economic and societal burden of...
Summary
\"Diabetes is the #1 health challenge of the 21st century. Continuous Glucose Monitoring or CGM ($1.25B market in 2016, growing 29%/yr) is today’s cornerstone of “diabetes self-management†and the most effective solution to reduce the economic and societal burden of diabetes. But the shortcomings of current CGMs hinder their wider adoption: high cost, unsatisfactory predictability of severe events, and poor user comfort.
The DiaMOND project removes these barriers by bringing a longterm, implantable, cost-effective Continuous Diabetes Monitoring (CDM®) to the market.
The CDM sensor will, as a first, allow personalised management by accurately monitoring all the biomarkers at play in diabetes control, and not only glucose. CDM can prevent severe clinical events such as hypo- and hyperglycaemia and ketoacidosis, rather than just monitoring them.
Indigo’s CDM uses Indigo\'s patented multi-biomarker spectrometer integrated on a chip that is implanted subcutaneously. DiaMOND is specifically geared at extending Indigo’s current CGM to a CDM with multi-biomarker sensing, reliable severe clinical event prediction and a great user experience; demonstrating the reliability in a first-in-man trial; creating market acceptance by involving Key Opinion Leaders; and obtaining reimbursement.
Indigo will be ready for a large pivotal clinical study and CE marking after completing the DiaMOND project.\"
Work performed
The DiaMOND project is being executed according to the plan to develop a continuous multi-biomarker sensor or CDM.
During the first year of the project, we have geared all resources towards:
1. the manufacturing of the prototypes. CGM sensor prototypes have been manufactured and are modified to enable multiparameter measurements, or said differently, we built CDM sensor prototypes successfully
2. in-vitro demonstration of our multi-biomarker sensor. We have shown in-vitro that we can measure multiple biomarkers with our CDM sensors with a clinical acceptable accuracy
3. pre-clinical in-vivo demonstration of our multi-biomarker sensor. We have shown pre-clinically in-vivo that we can measure multiple biomarkers with our CDM sensors with a clinical acceptable accuracy
4. clinical in-vivo demonstration of the strength of multi-biomarker knowledge. We are collecting clinical data in-vivo to support our predictive and preventive algorithms to be developed in the next phase of the project.
5. assess market-access challenges and strategies for a multi-biomarker sensor
Final results
Continuous Glucose Monitoring (CGM) is today’s cornerstone of “diabetes self-management†and has proven itself as the most effective solution to reduce the economic and societal burden of diabetes.
Current CGM devices suffer, however, from drawbacks that hinder their wider adoption: reliability and predictability of severe events are low, user comfort and discreteness are poor and cost is high. On top of this, new successful treatments such as SGLT-2 inhibitors introduce new risks such as Diabetes Keto-acidosis (DKA) that requires companion diagnostics.
The DiaMOND project aims at removing these barriers by bringing a disruptive Continuous Diabetes Monitoring (CDM) system to market. This CDM medical device will for the first time allow personalised diabetes management by accurately monitoring all the relevant biomarkers and not only glucose.
Diabetes is essentially a disease of the body’s energy delivery and storage system and is controlled by both the glucose and the lipid metabolism. Measuring only glucose cannot result in reliable and consistent diabetes management.
For the very first time, diabetes patients will have with Indigo’s CDM the tools to prevent severe, critical events, and not only monitor them.
Today, within the first year of the DiaMOND project, we have proven for the very first time world wide the successful operation of a multi-biomarker at clinical accuracies in-vivo.
Website & more info
More info: https://indigomed.com/diamond/.