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| Name | Class |
|---|---|
| Integrated Medical Development | INDUSTRY |
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The purpose of the investigation is to obtain sufficient preliminary information about the performance of the TrueVie Continuous Glucose Monitoring (CGM) device to identify any need for any design modifications.
After being informed about the study and potential risks, all participants giving written informed consent will be screened for participation. Qualifying participants will insert CGM sensors and come to 3 clinic visits at the beginning, middle and end of the 15 days intended sensor life. At the clinic visits participants are served two meals and perform a brief period of exercise of moderate intensity while blood samples are drawn according to a planned schedule timed to coincide with the TrueVie measurements.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| With oral ascorbic acid | 1 g ascorbic acid orally |
| |
| Without oral ascorbic acid | No oral ascorbic acid is taken |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous glucose monitoring device | Device | Continuous glucose monitoring device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | safety is assessed by adverse events | 15 days |
| Incidence of Treatment-Emergent Adverse Device Events | safety is assessed by adverse device effects | 15 days |
| Insertion Site Intensity of any Erythema on a Likert scale | tolerability by intensity of erythema at the insertion site | 15 days |
| Insertion Site Erythema Size estimated from Lengths of Major and Minor Axis | tolerability by size of erythema at the insertion site | 15 days |
| Edema by Maximal Height from Surrounding Skin Surface | tolerability by edema at insertion site | 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| Sensor Accuracy by Mean Absolute Glucose Concentration Difference from Reference | Sensor accuracy will be determined against plasma glucose concentrations determined by laboratory quality instrumentation | 15 days |
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Inclusion Criteria:
1 Type 1 diabetes mellitus 2. Must be and have been in stable treatment regimen for at least 3 months with a multiple daily insulin dosing regimens or Continuous Subcutaneous Insulin Infusion (CSII), irrespective of delivery device(s).
3. Must have normal exercise tolerance.
Exclusion Criteria:
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Patients with type 1 diabetes
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| Name | Affiliation | Role |
|---|---|---|
| Poul Strange, MD, PhD | Integrated Medical Development | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rainier Clinical Research Center | Renton | Washington | 98057 | United States |
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| ID | Term |
|---|---|
| D000095583 | Continuous Glucose Monitoring |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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| Laboratory plasma glucose concentration determination | Other | Laboratory plasma glucose concentration determination |
|
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D008919 | Investigative Techniques |