Eversense® Non-adjunctive Use Post Approval Study

This is a non-blinded, prospective, multi-center, single arm longitudinal cohort study (patient serving as their own control), to evaluate the effectiveness of diabetes with the Eversense CGM System non-adjunctively compared to self-monitoring of blood glucose (SMBG) using a blood glucose (BG) meter in participants with either Type 1 or Type 2 diabetes. Subjects will serve as their own control, with their baseline based on using SMBG to manage their diabetes for the first 6 months followed by using Eversense CGM System non-adjunctively for the second 6 months. Total follow-up duration is 12 months. The investigation will include both clinic visits and home use of Eversense CGM System. The nonadjunctive phase will have two sensors, up to 90-day duration, inserted sequentially. All care decisions specific to diabetes will be based on blood glucose (BG) values in the first phase and the Eversense CGM system values in the second phase.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

LA Universal Research Center, Inc., Los Angeles, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subject has diabetes
Subject is ≥18 years of age
Subject has a smartphone that is internet enabled
Subject is able to comply with study protocol tasks and understand written and verbal instructions in the investigator's opinion
Subjects is willing and able to provide written signed and dated informed consent

Exclusion criteria

Subject is critically ill or hospitalized
Prior use of CGM defined as:

No more than 1 week of continuous CGM use in the last 6 months, and
At least 4 weeks of continuous use of CGM in the last 12 months or 12 weeks total use in the past 3 years.
Subject has a known contraindication to dexamethasone or dexamethasone acetate
Subjects requiring intravenous mannitol or mannitol irrigation solutions
Subject is on dialysis at the time of enrollment
Female subjects who are pregnant, planning on becoming pregnant or nursing

Treatment and study plan

Blood glucose meter

Device

First phase: SMBG for 6 months

Eversense CGM System

Device

Second phase: CGM for 6 months

Primary outcomes

Incidence of moderate and severe hypoglycemic and diabetic ketoacidosis events

Time frame: First 6 months (phase 1) compared to second 6 months (phase 2)

Incidence of moderate and severe hypoglycemic and diabetic ketoacidosis events with SMBG use for 6 months compared to Eversense CGM system used non-adjunctively for 6 months

Sponsors and collaborators

Lead sponsor

Senseonics, Inc.

Industry

Registry information

Official study title

A Post Approval Study to Evaluate the Safety and Effectiveness of the Eversense® Continuous Glucose Monitoring (CGM) System Used Non-adjunctively

Acronym: NA-PAS

Important dates

Study start: 2021
Primary completion: 2026
Study completion: 2026
First posted: Apr 8, 2021
Registry last updated: Aug 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting