NCT02696252

Brief Summary

Comparison of G5® Mobile Continuous Glucose Monitoring System Accuracy When Using an Automated Applicator vs. a Manual Sensor Applicator

Trial Health

87
On Track

Trial Health Score

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

Enrollment
97

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2016

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

January 25, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 2, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

April 14, 2016

Status Verified

April 1, 2016

Enrollment Period

3 months

First QC Date

January 25, 2016

Last Update Submit

April 13, 2016

Conditions

Diabetes Mellitus

Keywords

Endocrine System DiseasesGlucose Metabolism DisordersMetabolic Diseases

Outcome Measures

Primary Outcomes (1)

  • proportion of blood glucose values, compared between CGM and a lab glucose analyzer that are matched relative to a diabetes accuracy measurement of %20/20 mg/dL

    7 days

Study Arms (1)

CGM Users

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults and pediatrics with diabetes mellitus

You may qualify if:

  • Ages 2 or older
  • Diagnosis of Type 1 diabetes or Type 2 diabetes
  • Willing to participate in a clinic session involving venous sampling for evaluation of study end point

You may not qualify if:

  • Use of acetaminophen
  • Known allergy to medical-grade adhesives
  • Pregnancy
  • Hematocrit outside specification of the study-assigned blood glucose meter

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

AMCR Institute

Escondido, California, 92025, United States

Location

Rocky Mountain Diabetes and Osteoporosis Center

Idaho Falls, Idaho, 83404, United States

Location

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Location

Clinical Trials of Texas

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Diabetes MellitusEndocrine System DiseasesGlucose Metabolism DisordersMetabolic Diseases

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2016

First Posted

March 2, 2016

Study Start

January 1, 2016

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

April 14, 2016

Record last verified: 2016-04

Locations

US(4)