Eversense CGM System for Diabetes

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Diabetes
Eversense CGM System - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is designed to study how well the Eversense CGM system works compared to self-monitoring of blood sugar in managing diabetes. The study will last for 12 months and will include clinic visits and home use of the Eversense CGM system.

Treatment Effectiveness

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: First 6 months (phase 1) compared to second 6 months (phase 2)

Month 6
Incidence of moderate and severe hypoglycemic and diabetic ketoacidosis events

Trial Safety

Trial Design

1 Treatment Group

Self monitoring of blood glucose, then CGM System
1 of 1

Experimental Treatment

925 Total Participants · 1 Treatment Group

Primary Treatment: Eversense CGM System · No Placebo Group · N/A

Self monitoring of blood glucose, then CGM SystemExperimental Group · 2 Interventions: Eversense CGM System, Blood glucose meter · Intervention Types: Device, Device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Blood glucose meter
2018
N/A
~180

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: first 6 months (phase 1) compared to second 6 months (phase 2)

Who is running the clinical trial?

Senseonics, Inc.Lead Sponsor
8 Previous Clinical Trials
813 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a smartphone that is internet enabled.
You are able to comply with study protocol tasks and understand written and verbal instructions in the investigator's opinion.
You are willing and able to provide written informed consent.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 13th, 2021

Last Reviewed: November 21st, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Maryland50.0%
Florida25.0%
Tennessee25.0%
How old are they?
18 - 65100.0%
What site did they apply to?
The Center for Diabetes and Endocrine Care33.3%
Atlanta Diabetes Associates33.3%
Southern Maryland Medical Group33.3%
What portion of applicants met pre-screening criteria?
Met criteria75.0%
Did not meet criteria25.0%