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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 5, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 7, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 12, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 12, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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