Diabetes Mellitus
Conditions
Keywords
Diabetes Mellitus
Brief summary
To establish the performance of the Dexcom G4 Platinum with a Modified Algorithm continuous monitoring system when compared to a laboratory reference measurement.
Detailed description
A study to evaluate the performance of a modification to the G4 Platinum CGM system in adults with diabetes.
Interventions
DEVICEContinuous Glucose Monitoring
A prescribed clinic session day for participating subjects.
Sponsors
DexCom, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Percentage of Agreement of the Continuous Glucose Monitoring System Glucose Values Comparing to a Laboratory Reference, Yellow Sprint Instrument (YSI) Measurement. | 7-day wear period | The percentage of CGM 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Real Time Continuous Glucose Monitoring System Real Time Continuous Glucose Monitoring System Wear over a 7 day period | 51 |
| Total | 51 |
Baseline characteristics
| Characteristic | Real Time Continuous Glucose Monitoring System |
|---|---|
| Age, Continuous | 46.7 years old STANDARD_DEVIATION 15.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 48 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 48 Participants |
| Region of Enrollment United States | 51 participants |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 51 |
| other Total, other adverse events | 1 / 51 |
| serious Total, serious adverse events | 0 / 51 |
Outcome results
Primary
The Percentage of Agreement of the Continuous Glucose Monitoring System Glucose Values Comparing to a Laboratory Reference, Yellow Sprint Instrument (YSI) Measurement.
The percentage of CGM 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.
Time frame: 7-day wear period
Population: For the demographic and other baseline characteristic information, data from all 51 enrolled subjects was summarized.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Real Time Continuous Glucose Monitoring System | The Percentage of Agreement of the Continuous Glucose Monitoring System Glucose Values Comparing to a Laboratory Reference, Yellow Sprint Instrument (YSI) Measurement. | 93 Units analyzed% matched pairs w/i %20/20 |