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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Type 1 or 2 diabetes, MDI or pump |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FreeStyle Navigator II Continuous Glucose Monitoring System | Device | This is not an interventional study. Subjects must maintain their own diabetes treatment regimen throughout the study duration |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 15 days sensor wear |
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Inclusion Criteria:
The subject must:
Exclusion Criteria:
The subject must not:
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Patients with type 1 or 2 diabetes requiring multiple daily insulin injections or using an insulin pump
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| Name | Affiliation | Role |
|---|---|---|
| Shridhara A Karinka, Ph.D. | Abbott Diabetes Care | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atlanta Diabetes Associates | Atlanta | Georgia | 30309 | United States | ||
| Southwest Clinical Research Center |
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Participants were recruited from within the patient population of two US diabetes clinical centers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Observational Group | Participants using the FreeStyle Navigator II RT-CGM for 15 days (360 hours). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Observational Group | Participants using the FreeStyle Navigator II RT-CGM for 15 days (360 hours). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Number | Percentage of Results | 15 days sensor wear | Results | Participants |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Observational Group | Participants using the FreeStyle Navigator II RT-CGM for 15 days (360 hours). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Severe hypoglycemia | Endocrine disorders | Non-systematic Assessment | Not device related, Not procedure related, Severity = Severe, non-serious adverse event, unanticipated |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shridhara A. Karinka, Ph.D., Director of Clinical Affairs | Abbott Diabetes Care | 510-749-6393 | SHRIDHARA.ALVA@ABBOTT.COM |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Santa Fe |
| New Mexico |
| 87505 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Weight | Mean | Full Range | kilograms |
|
| Height | Mean | Full Range | meters |
|
| Years since diagnosis | Mean | Full Range | years |
|
| Daily total insulin dosage | Mean | Full Range | units |
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| Total number of injections per day | Mean | Full Range | injections (N subjects = 18) |
|
| Participants |
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| Results |
|
|
| 0 |
| 31 |
| 4 |
| 31 |
|
| Scabbing | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Device-related, procedure-related, severity = moderate, non-serious adverse event, anticipated. Device-related, procedure-related, severity = mild, non-serious adverse event, anticipated. |
|
| Pruritus | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Device-related, procedure-related, severity = mild, non-serious adverse event, anticipated |
|
| Erythema | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Device-related, procedure-related, severity = mild, non-serious adverse event, anticipated |
|
| Laryngitis | General disorders | Non-systematic Assessment | Not device related, not procedure related, severity = moderate, non-serious adverse event, unanticipated |
|
| Ear infection in right ear | Infections and infestations | Non-systematic Assessment | Not device related, not procedure related, severity = moderate, non-serious adverse event, unanticipated |
|
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