Completed

Accuracy Evaluation of Abbott Sensor Based Interstitial Glucose Monitoring System

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
Study Aim

This study aims to evaluate the accuracy of the Abbott Sensor Based Interstitial Glucose Monitoring System by using the Consensus Error Grid, a tool to assess clinical point accuracy.

What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Autoimmune Diseases+6

+ Diabetes Mellitus

+ Diabetes Mellitus, Type 1

Over 18 Years
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: February 2014
See protocol details

Summary

Principal SponsorAbbott Diabetes Care
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2014

Actual date on which the first participant was enrolled.

The purpose of this study is to demonstrate point accuracy of the Abbott Sensor Based Glucose Monitoring (GM) System interstitial glucose results against Reader capillary Blood Glucose (BG) reference using the Consensus Error Grid. During the course of the wear duration, the subject is required to test fingerstick glucose measurement at least eight (8) times a day for capillary reference glucose measurements and three in-clinic visits of a maximum 13 hours each for venous reference glucose measurements. With every reference measurement, the subject or study staff will perform a measurement on the System.

Official TitleEvaluation of the Accuracy of the Abbott Sensor Based Interstitial Glucose Monitoring System
NCT02073058
Principal SponsorAbbott Diabetes Care
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

75 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Autoimmune DiseasesDiabetes MellitusDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2Endocrine System DiseasesImmune System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism Disorders

Criteria

Inclusion Criteria: 1. Subject must be at least 18 years of age. 2. Subject must have type 1 or type 2 diabetes for at least 2 years prior to enrollment. 3. Subject must require insulin therapy through an insulin pump and/or multiple daily insulin injections (at least 3 injections daily) for at least 6 months prior to enrollment. 4. Subject must be able to read and understand English. 5. In the investigator's opinion, the subject must be able to follow the instructions provided to him/her by the study site and perform all study tasks as specified by the protocol. 6. Subject must be available to participate in all study visits. 7. Subject must be willing and able to provide written signed and dated informed consent. Exclusion Criteria: 1. Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin. 2. Subject is pregnant, attempting to conceive or not willing and able to practice birth control during the study duration (applicable to female subjects only). 3. Subject has skin lesions, scarring, redness, infection or edema at the application sites that could interfere with device placement or the accuracy of interstitial glucose measurements. 4. Subject currently is participating in another clinical trial. 5. Subject has donated blood within 112 days (3.7 months) prior to the beginning of the study activities. 6. Subject has concomitant medical condition which, in the opinion of the investigator, could interfere with the study or present a risk to the safety or welfare of the subject or study staff. Such conditions include but are not limited to: • History of HIV, Hepatitis B or C 7. Subject has a known medical condition that, in the opinion of the investigator, may increase the risk of bleeding. 8. Subject has X-ray, MRI or CT appointment scheduled during the period of study participation, and the appointment cannot be rescheduled for a time before study participation starts or after study participation ends. 9. Subject is unsuitable for participation due to any other cause as determined by the Investigator.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 4 locations

Suspended

AMCR Institute

Escondido, United StatesOpen AMCR Institute in Google Maps
Suspended

Diablo Clinical Research

Walnut Creek, United States
Suspended

Atlanta Diabetes Associates

Atlanta, United States
Suspended

Rainier Clinical Research Center

Renton, United States
Completed4 Study Centers