Diabetes
Conditions
Brief summary
This research study will test a new investigational continuous glucose monitoring system (System). The purpose of this study is to find out about the performance of the System in a home use environment over a 15 day period, in people with diabetes.
Interventions
DEVICEFreeStyle Navigator II Continuous Glucose Monitoring System
This is not an interventional study. Subjects must maintain their own diabetes treatment regimen throughout the study duration
Sponsors
Abbott Diabetes Care
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The subject must: * Have type 1 or 2 diabetes for at least 2 years prior to enrollment. * Require insulin therapy administered through an insulin pump or multiple daily injections (MDI) for at least 6 months prior to enrollment. * Be at least 18 years of age. * Be able to read and understand English. * In the investigator's opinion, be able to follow the instructions provided to him/her by the study site and perform all study tasks as specified by the protocol. * Be available for all study visits. * Be willing to provide written signed and dated informed consent.
Exclusion criteria
The subject must not: * Be pregnant or likely to become pregnant during the study duration. * Have skin abnormalities at the insertion sites. * Have known allergy to medical grade adhesive or skin disinfectant. * Be using a continuous glucose monitor currently or within the past 6 months * Have a 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. * Be participating in another clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clarke Error Grid Analysis | 15 days sensor wear | Percentage of CGM results in the clinically accurate Zone A and percentage of CGM results in the clinically acceptable Zones A and B of the Clarke Error Grid versus blood glucose reference. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from within the patient population of two US diabetes clinical centers.
Participants by arm
| Arm | Count |
|---|---|
| Observational Group Participants using the FreeStyle Navigator II RT-CGM for 15 days (360 hours). | 31 |
| Total | 31 |
Baseline characteristics
| Characteristic | Observational Group |
|---|---|
| Age, Customized | 48.4 years |
| Daily total insulin dosage | 72.8 units |
| Height | 1.70 meters |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 16 Participants |
| Total number of injections per day | 3.6 injections (N subjects = 18) |
| Weight | 90.4 kilograms |
| Years since diagnosis | 19.6 years |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 4 / 31 |
| serious Total, serious adverse events | 0 / 31 |
Outcome results
Primary
Clarke Error Grid Analysis
Percentage of CGM results in the clinically accurate Zone A and percentage of CGM results in the clinically acceptable Zones A and B of the Clarke Error Grid versus blood glucose reference.
Time frame: 15 days sensor wear
Population: One subject was withdrawn due to a mild reaction to the sensor adhesive. This subject's data was included in the study up to the point of withdrawal.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Observational Group | Clarke Error Grid Analysis | Percentage of results in Clarke Error Zone A | 83.0 Percentage of Results |
| Observational Group | Clarke Error Grid Analysis | Percentage_Results in Clarke Error Zones A&B | 97.7 Percentage of Results |