Long-term, Implantable Sensor Improves Health Outcomes in Patients With T1D
Long-term, Implantable Sensor Improves Health Outcomes in Patients With T1D
The implantable Eversense ® CGM System obtained CE marking in 2016 for the 90-day device and
 in 2017 for the 180-day device.There is interest in real-world clinical evidence on the use
 of Eversense regarding changes in HbA1c and time in range (TIR), time below range (TBR), and
 time above range (TAR) in patients with type 1 diabetes. This is a prospective, multi-center,
 observational clinical study among adult participants aged 18 years or older with T1D and
 Eversense CGM System-naïve aimed to evaluate the change in HbA1c and glucometric parameters
 (TIR, TAR, TBR, mean daily glucose and standard deviation) in patients with T1D from multiple
 clinics in Italy using the Eversense CGM System for a 6-month time period.
A new continuous glucose monitoring system (CGM), the Eversense ® CGM System (Company
 Senseonics, Inc., location of Company Germantown, MD) has been developed and commercially
 introduced in the last 3 years. This system may overcome drawbacks and limitations of
 traditional transcutaneous CGM systems. It consists of a fully implantable sensor lasting up
 to 180 days, a removable smart transmitter providing unique on-body vibratory alerts, and a
 mobile medical app (MMA) displaying glucose information captured and calculated by the
 transmitter. The app generates pop-up messages and alerts for glucose values crossing low and
 high thresholds, rate of change of glucose exceeding pre-set limits, and predicted low and
 high glucose levels. Glucose data are uploaded and stored in the cloud. Data from the cloud
 can be analyzed to provide different glucometric parameters such as time in range (TIR,
 70-180 mg/dL), time below range (TBR, <70mg/dL), time above range (TAR, >180 mg/dL), mean
 daily glucose levels, and standard deviation (SD). The safety and accuracy of the new system
 has been evaluated in the PRECISE, PRECISE II and the PRECISION studies. The accuracy of the
 system is very high and no serious adverse events and very few adverse events have been
 reported in pivotal trials. Among adverse events, redness/erythema, bruising and pain at the
 sensor insertion site occurred. The purpose of this analysis will be to evaluate the change
 in HbA1c and in glucometric parameters, such as TIR, TBR, TAR, mean daily glucose, and SD in
 patients with T1D from multiple clinics in Italy using the Eversense CGM System for a 6-month
 time period. This is a prospective, multi-center, observational clinical research study among
 adult participants aged 18 years or older with T1D across several diabetes-care centers in
 Italy. Patients will be required to be Eversense CGM System-naïve. Patients will be trained
 on the Eversense CGM System use before sensor insertion, as suggested by the current clinical
 practice recommendations. Specifically, they will be instructed about the principles of the
 sensor technology, the operational aspects of the device, and the interpretation of displayed
 data. No specific therapeutic recommendations will be suggested to adjust pre-meal insulin
 dosing. Patients will be advised to take an action when alerts will be asserted, according to
 general recommendations, including checking the glucose value using a traditional blood
 glucose meter. The following parameters will be collected for each patient: HbA1c (measured
 using high-performance liquid chromatography) within two months before sensor implantation
 and 6 months after the implantation, disease duration, prior use of CGM, and insulin therapy
 delivery mode (MDI or CSII). The Eversense CGM System consists of an implantable,
 fluorescence-based, long-term sensor; the smart transmitter worn on top of the skin above the
 sensor; and the medical mobile app (MMA) which operates on a mobile device (smart phone,
 smart watch, or iPad) and provides real-time monitoring of current and historical glucose
 values. The long-term sensor will be implanted by trained endocrinologists into the
 subcutaneous tissue of the upper arm at the end of the deltoid muscle in all patients.
 Patients will be registered in the Eversense Data Management System (DMS) allowing automatic
 uploading of sensor glucose data. Study participants will be followed according to local
 practice. The euglycemic target (TIR, glucose 70-180 mg/dL), TAR (glucose >180 mg/dL), TBR
 (glucose <70 mg/dL), mean overall daily glucose, and mean SD, will be collected from the DMS
 over the first 2 weeks after the first sensor implantation (baseline) and 2 weeks before the
 6-month visit. HbA1c and CGM metric changes in patients using CSII and MDI treatment for
 insulin delivery, and in patients who were CGM-naïve and prior CGM users will be assessed to
 observe the differences by prior CGM use and method of insulin delivery. Specifically,
 patients will be categorized into four different subgroups: CSII and prior CGM use, CSII and
 CGM naïve, MDI and prior CGM use, and MDI and CGM naïve. Appropriate tests will be performed
 using SPSS (Statistical Package for Social Science) 23 for Macintosh. Variables not normally
 distributed will be analyzed with non parametric test or if necessary a 2-step rank
 transformation will be applied to normalize the variables. All patients will be informed
 about the finality of the research and they will be required to give informed consent in
 order to analyze data collected by the DMS. They will receive all scheduled visits according
 to clinical practice.
Inclusion Criteria:

 -  Type 1 diabetes

 -  Age >18 years

 -  Eversense ® CGM System-naïve

 Exclusion Criteria:

 -  candidates for a MRI during sensor wear

 -  critically ill including hospitalization

 -  known contradiction to dexamethasone

 -  required intravenous mannitol or mannitol irrigation solutions

 -  pregnancy