NCT03087877

Brief Summary

The objective of the study is to demonstrate effectiveness of the G6 sensor membrane, in preventing acetaminophen's interference effect on glucose sensing.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus

Timeline
Completed

Started Feb 2017

Shorter than P25 for not_applicable diabetes-mellitus

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 3, 2017

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

February 24, 2017

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 4, 2017

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 23, 2017

Completed
Last Updated

December 31, 2018

Status Verified

December 1, 2018

Enrollment Period

29 days

First QC Date

February 24, 2017

Last Update Submit

December 27, 2018

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Interference Effect for the G6 CGM

    Bias of sensor to reference measurement pre and post acetaminophen administration

    6 hrs post dose

Secondary Outcomes (2)

  • Mean of sensor minus YSI values (bias) for various time periods

    6 hrs post dose

  • Duration of interference effect for the G6 CGM

    6 hrs post dose

Study Arms (1)

CGM Users

OTHER

Prospective, non-randomized, single-arm. Continuous Glucose Monitoring. Acetaminophen challenge is the intervention.

Device: Acetaminophen Challenge (G6 CGM)

Interventions

Acetaminophen Challenge (G6 CGM)DEVICE

Evaluation of acetaminophen effect on CGM glucose sensing

CGM Users

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ages 18 or older
  • Diagnosis of diabetes

You may not qualify if:

  • Pregnancy
  • Known gastroparesis
  • Abnormal liver function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

AMCR

Escondido, California, 92025, United States

Location

William Sansum Diabetes Center

Santa Barbara, California, 93105, United States

Location

Diablo Clinical Research

Walnut Creek, California, 94598, United States

Location

Rainier Clinical Research Center Inc

Renton, Washington, 98057, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • David Price, MD

    DexCom, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
The system will be blinded to the user, i.e. no glucose values will be displayed to the subject during the study duration.
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2017

First Posted

March 23, 2017

Study Start

February 3, 2017

Primary Completion

March 4, 2017

Study Completion

March 4, 2017

Last Updated

December 31, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations

US(4)