Long-term, Implantable Sensor Improves Health Outcomes in Patients With T1D

November 8, 2019 updated by: Concetta Irace, University Magna Graecia

Clinical Use of the Long-term Implantable Sensor Improves Glycated Hemoglobin and Time in Range in Patients With Type 1 Diabetes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Catanzaro, Italy, 88100
        • University Magna Graecia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult participants aged 18 years or older who were suggested to wear long term sensor.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Type 1 diabetes
Subjects attending metabolic clinic who were suggested to use long term sensor due to persistent hyperglycemia and hypoglycemia
Device: Long term sensor
Observational study including subjects using long term sensor according to local guidelines and patients preferences

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c (%)
Time Frame: six months
Measured by High Performance Liquid Chromatography
six months
Time in Range (%)
Time Frame: six months
Collection from diabetes management system
six months
Time Below Range (%)
Time Frame: six months
Collection from diabetes management system
six months
Time Above Range (%)
Time Frame: six months
Collection from diabetes management system
six months
Mean Daily Glucose (mmol/l)
Time Frame: six months
Collection from diabetes management system
six months
Glucose Standard Deviation (mmol/L)
Time Frame: six months
Collection from diabetes management system
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Magna Graecia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 5, 2018

Primary Completion (Actual)

June 30, 2019

Study Completion (Actual)

June 30, 2019

Study Registration Dates

First Submitted

November 7, 2019

First Submitted That Met QC Criteria

November 8, 2019

First Posted (Actual)

November 12, 2019

Study Record Updates

Last Update Posted (Actual)

November 12, 2019

Last Update Submitted That Met QC Criteria

November 8, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Long term implantable sensor

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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