1. Insertable CGM technology with a 180 days sensor wear time: Latest clinical insight
Concetta Irace
Department of Health Science
University Magna Græcia, Catanzaro, Italy
Hosted on
ATTD 2019 Berlin

2. Disclosure Novo Nordisk Lilly Roche Diabetes Care Senseonics
ATTD Berlin February 22, 2019

3. Trends and Cyclical Variation in the Incidence of Childhood Type 1 Diabetes in 26 European Centres in the 25 Year Period 1989–2013
The incidence of type 1 diabetes
ATTD Berlin February 22, 2019
Diabetologia doi.org/ /s

4. State of Type 1 Diabetes Management and Outcomes from the T1D Exchange in 2016–2018
The number of CGM users is increasing. Howere still
ATTD Berlin February 22, 2019
Diabetes Technology & Therapeutics; 21(2) 2019

5. CGM Use Among Patients with Type 1 Diabetes
Trouble inserting the sensor
Discomfort wearing the sensor
Sensor dislocation playing sports and activities
Privacy reasons
Skin reaction to adhesive patch
Financial reasons
27% of CGM users discontinue use during the first year (T1 Exchange Registry 2016)
Despite the highlighted benefits, CGM usage among patients with T1D is still limited with even poorer uptake among patients with type 2 diabetes (T2D) (13-16). As well as financial reasons due to limited reimbursement, reasons for this situation include the perceived burden of frequent insertions, the fear of pain or discomfort, the likelihood of accidental sensor dislocation, potential drug interferences, privacy reasons or the occurrence of skin reactions to the adhesive (17-20). Most of these challenges relate directly to the core design of any needle type CGM system based on glucose oxidation (21, 22).
ATTD Berlin February 22, 2019

6. Eversense® CGM System Smart Transmitter Sensor Mobile App
Fully implanted
Small size
Up to 180 days
Smart Transmitter
On-body vibe alerts
Removable/Rechargeable
Gentle adhesive
A novel option is the Eversense® system (Senseonics, Germantown, Maryland), which is the first long-term implantable rtCGM technology (25, 26). The system consists of a sensor, a smart transmitter, and a dedicated smartphone application. The sensor has a usability of up to 180 days without the need for sensor replacement and allows for the flexibility to remove the externally worn transmitter if necessary or as desired. This vastly extended wear time becomes feasible since the basis of the glucose measurement involves a fully reversible chemical reaction. Using photometric means, the long-term implantable CGM measures the emission of fluorescence from indicator polymers which bind reversibly to specific functional groups of glucose The Eversense system consists of 3 components:
The first component is a small, fully implantable sensor which is placed subcutaneously in the upper arm and lasts up to 90 DAYS of continuous use.
The second component is a smart transmitter which is worn on top of the skin over the sensor, and provides on-body vibratory alerts when glucose is low or high. The transmitter is REMOVABLE and RECHARGEABLE and is kept in place with a gentle, silicone-based adhesive that is changed daily for comfort.
The last component is a mobile application which provides real-time glucose readings EVERY 5 MINUTES with no need for an extra receiver. The application also shows…
glucose trends,
provides alerts,
and reminds the user to enter calibration data.
Real-time readings
No extra receiver
Trends, alerts w/ predictive
ATTD Berlin February 22, 2019

7. Patient Selection
Patients with type 1 and type 2 diabetes with frequent hypoglycemic events
Patients with persistent high HbA1c despite intensive treatment
Patients with nocturnal and hypoglycemia unawareness
Patients who benefit from on-body alerts
Patients who perceive frequent sensor replacement as a burden
Patients requiring to remove the transmitter
Patients at enhanced risk of accidentally pulling off transcutaneous sensor
Fear of pain, needle-phobia
Physical constrains limiting self-application
Adhesive patch reaction after continuative use
Besides the benefits of the longevity of the sensor, patients should be made aware that “trial” insertions for a very limited time (a couple of days) are not advisable. Thus, for patients in doubt of the applicability of the CGM technology to their lifestyle, should gain experience using a short-term CGM system, e.g isCGM and should subsequently switch to the long-term implantable rtCGM device once convinced that the technology is right for them.
ATTD Berlin February 22, 2019

8. In-office Sensor Placement
ATTD Berlin February 22, 2019

9. The updated Eversense Blunt Dissector
Updated Design to support:
Uniform angle of entry
Optimal depth and length of pocket
Consistent, precise sensor placement
Ergonomic enhancement
ATTD Berlin February 22, 2019

10. Accuracy and Longevity of an Implantable Continuous Glucose Sensor in the PRECISE Study: A 180-Day, Prospective, Multicenter, Pivotal Trial
MARD: [(CGM value – YSI value) / YSI value] x 100
ATTD Berlin February 22, 2019
Diabetes Care 2017;40:63–68

11. A Prospective Multicenter Evaluation of the Accuracy of a Novel Implanted Continuous Glucose Sensor: PRECISE II
ATTD Berlin February 22, 2019
Diabetes Technology & Therapeutics 2018 Doi: /Dia

12. Acceptance in Italy: Specific Data
Customer Satisfaction
Procedure Feedback
Indossano perchè soddisfatti
767 implanted sensor
ATTD Berlin February 22, 2019
Italy customer survey 2018

13. Long-term sensor wear Time across Europe
SENSEONICS INC. CONFIDENTIAL JANUARY 2018
1313
Long-term sensor wear Time across Europe
June 21, 2018 was a very special day for Senseonics in the US.  On June 21, the FDA approved the Eversense CGM System, the world's first long term implantable sensor, for people with diabetes 18 years of age and older.
The system is only new to America though. We received CE Mark in in 2016, and have launched in 14 countries around the globe.
ATTD Berlin February 22, 2019

14. Long-term sensor Time In Range (TIR) across Europe
SENSEONICS INC. CONFIDENTIAL JANUARY 2018
1414
Long-term sensor Time In Range (TIR) across Europe
June 21, 2018 was a very special day for Senseonics in the US.  On June 21, the FDA approved the Eversense CGM System, the world's first long term implantable sensor, for people with diabetes 18 years of age and older.
The system is only new to America though. We received CE Mark in in 2016, and have launched in 14 countries around the globe.
ATTD Berlin February 22, 2019

15. HbA1c and Time In Range (TIR) in a sample of Italian long-term sensor users
Baseline
6 month
P value
Number 21
---
HbA1c (mmol/mol)
56.1±8.2
49.5±6.4
0.004
HbA1c (%)
7.3±2.9
6.7±2.7
Time in Range [ mg/dL] (%)
43.4±12.6
58.3±15.3
0.02
Glucose Standard Deviation (mmol/mol)
3.3±0.6
2.8±0.7
Glucose Standard Deviation (mg/dL)
59.4±10.8
50.4±12.6
ATTD Berlin February 22, 2019

16. PRECISE II Pivotal Trial of A Long Term Implantable CGM System: 90 Days of Sustained Accuracy and Strong Safety Profile
ADA 2017
ATTD Berlin February 22, 2019

17. Sensor Incision First sensor implanted Three sensors implanted
ATTD Berlin February 22, 2019

18. ATTD Berlin February 22, 2019