Effectiveness and Safety Study of the Dexcom G4 Platinum With Modified Algorithm

Diabetes Mellitus Clinical Trial

Official title:

Effectiveness and Safety Study of the Dexcom G4 Platinum With Modified Algorithm

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02087995
• Other study ID #: PTL901100
• Status: Completed
• Phase: N/A
• First received: February 3, 2014
• Last updated: February 10, 2015
• Start date: December 2013
• Est. completion date: March 2014

Study information

• Verified date: February 2015
• Source: DexCom, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To establish the performance of the Dexcom G4 Platinum with a Modified Algorithm continuous monitoring system when compared to a laboratory reference measurement.

Description:

A study to evaluate the performance of a modification to the G4 Platinum CGM system in adults with diabetes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Ages 18 years or older

• Diagnosis of Type 1 diabetes or Type 2 diabetes on Intensive Insulin Therapy (ITT)

• Willing to participate in a clinic session

Exclusion Criteria:

• Use of Acetaminophen during study period

• Pregnancy

• Hematocrit (HCT) <35% (females) and 38% (males)

• Dialysis, history of cardiovascular disease, epilepsy, severe migraines in the past 6 months, adrenal disease, syncope, significant hypoglycemia unawareness, or a history of severe hypoglycemia within the last 6 months.

• Any condition that, in the opinion of the Investigator, would interfere with their participation in the study or pose and excessive risk to study staff.

Study Design

Intervention Model: Single Group Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Device:
• Continuous Glucose Monitoring
A prescribed clinic session day for participating subjects.

Locations

Country	Name	City	State
United States	John Muir Physician Network Clinical Research	Concord	California
United States	AMCR Institute	Escondido	California
United States	Diablo Clinical Research, Inc.	Walnut Creek	California

Sponsors (1)

Lead Sponsor	Collaborator
DexCom, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage of agreement of the System compared to a laboratory reference measurement.	the proportion of System values that are within 20% of the reference value for YSI glucose levels > 80 mg/dL or within 20 mg/dL at the reference glucose levels < 80 mg/dL.	7-day wear period	No