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Long-Term Implantable Continuous Glucose Monitoring System Makes for Easier Diabetic Control

Ruth Platt

The University of Texas at Tyler, School of Nursing

NURS 5324: Health Care Informatics

Jerri Post, PhD, RN

October 4, 2021

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Peer-Reviewed Article in Journal

Title of Article: Clinical Practice Recommendations on the Routine Use of Eversense, the First Long-Term Implantable Continuous Glucose Monitoring System

Journal: Diabetes Technology and Therapeutics, Volume 21

Authors: Dorothee Deiss, MD, Agnieszka Szadkowska, MD, Debbie Gordon, MD, Akhila Mallipedhi, MD, Ingrid Schütz-Fuhrmann, MD, Eva Aguilera, MD, Corina Ringsell, Dr, Christophe De Block, MD, and Concetta Irace, MD

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Date Article Published: November 5, 2019

Eversense received FDA approval on June 6, 2019 (U. S. Food and Drug Administration, n.d.).

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Eversense is a continuous glucose monitoring system (CGM) implanted into the upper arm. Eversense "uses a patented fluorescent glucose-indicating polymer technology to measure glucose in the interstitial fluid (a thin layer of fluid that surrounds the body's cells)" (Ascensia Diabetes Care, 2021). An adhesive strip attaches a transmitter to the skin, and the transmitter relays readings from the implanted sensor directly to a mobile app every 5 minutes. The Eversense transmitter can vibrate to alert the wearer when glycemic readings are outside parameters programmed into the app. The Eversense is approved by the U.S. Food and Drug Administration (FDA) for up to 90 days of use. The company is working on an upgraded implantable model that will last for up to 180 days.

(Deiss et al., 2019)

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(Eversense CGM, 2019)

Journal Article: https://www.liebertpub.com/doi/pdf/10.1089/dia.2018.0397

Eversense Website: https://global.eversensediabetes.com/

FDA Approval: https://www.fda.gov/medical-devices/recently-approved-devices/eversense-continuous-glucose-monitoring-system-p160048s006

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· Longer lasting – Up to 90 days

· Glucose readings every 5 minutes

· Glucose readings sent to a smartphone app

· Transmitter vibrate to alert patients to hypoglycemic or hyperglycemic events

· Removable transmitter

· Less skin irritation (daily adhesive changes)

· Less noticeable

· Less chance of dislodgement

(Deiss et al., 2019)

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· Must be implanted and removed by a doctor

· Doctors need to be trained on installation procedure

· Only available for those ages 18 and up

· Minimally invasive procedure

· Procedure can leave scars

· Does not currently work with insulin pumps, must administer own insulin

· Alarm fatigue depending on programming alerts

· Glucose readings can be affected by bright lights

· Expensive – new technology, not covered by some insurance

· Depending on sensor movement, might have difficulty removing the sensor

· Must check smartphone and app compatibility

· Two finger-stick calibrations daily

· Transmitter must be charged daily
· Cost

(Deiss et al., 2019)

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Diabetes affects 10.5% of the US population (National Diabetes Statistics Report, 2020, 2020). There are several continuous monitoring systems (CMS) available to help patients keep their glucose levels within normal limits. Patients need to discuss with their doctors which CMS would work the best for their diabetic needs.

I believe that for those who have visual, mental, or physical constraints that would not allow them to replace their own CMS at home every 10 days, the long-term CMS might be a better fit. However, the Eversense still requires two fingerstick calibrations daily (Deiss et al., 2019). The long-term CMS might also be better for those who are not able to check their readings frequently, as it has a vibration alert that can automatically notify a patient if their glucose is too high or too low.

The biggest drawback about this technology is that it does not currently function with an insulin pump. Users would still need to prepare and administer their own insulin. In addition, because it is a new technology, it can be expensive (especially if insurance does not currently cover it). In addition, it is currently only approved for those ages 18 and older (Deiss et al., 2019).

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From the Gallup Clifton Strengths Survey (2021), my top 5 strengths were:

1. Ideation

2. Analytical

3. Restorative

4. Relator

5. Individualization

These strengths fall under strategic thinking (ideation and analytical), executing (restorative), and relationship building (relator and individualization). As a team member, I would help bring new ideas of how to evaluate this new innovation (ideation) and how to determine the medical innovation's pros and cons (analytical). I would be able to help make connections and friendships within the team (relator). I would be able to determine the strengths of others and maximize the team's productivity by assigning people to the tasks that they are best suited (individualization).

(Fineout-Overholt, 2017)

Team Members:

1.      Chelsea – Command (Influencing): I do not have a strength listed under the influencing category. I am good at coming up with several ideas and suggestions but would prefer someone else make the big decisions. Chelsea would lead the group and make the hard decisions to move us forward on the project.

2.      Fernando – Focus (Executing): I have no problem starting projects, but finishing them is one of my biggest personal pitfalls. Fernando will help us stay focused and on track to complete the project.

3.      Faith – Futuristics (Strategic Thinking): With several strong personalities on this team, Faith can help find common ground when conflicts arise. Faith can ask the questions needed to study all sides of an issue. People with futuristics strengths are creative and might have different ways to look at the project than I do with my analytical brain.

4.      David – Deliberative (Executing)– A person with the deliberative strength takes time to make a good decision and anticipates problems. David will help us be prepared for any pitfalls we may encounter.

5.      Pablo – Positivity (Relationship Building) – A team needs to be cohesive and work together in a positive environment. Pablo will help get people excited about our project and help us all work together.

(Gallup, 2021)

(Fineout-Overholt, 2017)

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References

Ascensia Diabetes Care. (2021). Eversense. https://www.ascensiadiabetes.com/eversense/eversense-cgm-system/sensor/

Deiss, D., Szadkowska, A., Gordon, D., Mallipedhi, A., Schütz-Fuhrmann, I., Aguilera, E., Ringsell, C., De Block, C., & Irace, C. (2019). Clinical practice recommendations on the routine use of Eversense, the first long-term implantable continuous glucose monitoring system. Diabetes Technology & Therapeutics, 21(5), 254–264. https://doi.org/10.1089/dia.2018.0397

Eversense CGM. (2019, July 30). Eversense CGM | How The System Works [Video]. YouTube. https://www.youtube.com/watch?v=d4lepb2t4nE

Fineout-Overholt, E. (2017). Clifton StrengthsFinder Theme Names [Housing and Residential Life at the University of Minnesota]. Gallup, Inc.

Gallup. (2021). Cliftonstrengths online talent assessment. Retrieved August 5, 2021, from https://www.gallup.com/cliftonstrengths

Gallup. (2021). Cliftonstrengths online talent assessment. Retrieved August 5, 2021, from https://www.gallup.com/cliftonstrengths

National diabetes statistics report, 2020. (2020, August 28). CDC. Retrieved September 17, 2021, from https://www.cdc.gov/diabetes/data/statistics-report/index.html

U. S. Food and Drug Administration. (n.d.). Eversense continuous glucose monitoring system - P160048/S006. U.S. Food and Drug Administration. Retrieved September 17, 2021, from https://www.fda.gov/medical-devices/recently-approved-devices/eversense-continuous-glucose-monitoring-system-p160048s006