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Identification of risks of the GlucoTab system in routine use.
A study to identify risks in routine use of the GlucoTab system for glycaemic management in non-critically ill patients with type 2 diabetes at general wards.
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| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: Blood Glucose During Hospital Stay, an Expected Average of 1 Week | efficacy: mean daily blood glucose during hospital stay, an expected average of 1 week | participants will be followed for the duration of hospital stay, an expected average of 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: Blood Glucose During Hospital Stay | Efficacy: mean pre-breakfast blood glucose during hospital stay | participants will be followed for the duration of hospital stay, an expected average of 1 week |
| Usability: Coverage of the GlucoTab |
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Inclusion Criteria:
Exclusion Criteria:
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non-critically ill patients with type 2 diabetes at general wards
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| Name | Affiliation | Role |
|---|---|---|
| Thomas R. Pieber, Univ.Prof.Dr | Medical University of Graz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Graz | Graz | Styria | 8010 | Austria |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Diabetes therapy was performed according to the intended use of the GlucoTab system |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Diabetes therapy was performed according to the intended use of the GlucoTab system |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 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 | Efficacy: Blood Glucose During Hospital Stay, an Expected Average of 1 Week | efficacy: mean daily blood glucose during hospital stay, an expected average of 1 week | Posted | Mean | Standard Deviation | mg/dl | participants will be followed for the duration of hospital stay, an expected average of 1 week |
|
|
during hospital stay
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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 | Intervention | Diabetes therapy was performed according to the intended use of the GlucoTab system |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia and cardiac decompensation requiring treatment in intensive care unit | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cystitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas Pieber | MUG | 004331638512383 | thomas.pieber@medunigraz.at |
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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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Usability: coverage of the GlucoTab treatment during hospital stay
| Participants will be followed for the duration of hospital stay, an expected average of 1 week |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Secondary | Efficacy: Blood Glucose During Hospital Stay | Efficacy: mean pre-breakfast blood glucose during hospital stay | Posted | Mean | Standard Deviation | mg/dl | participants will be followed for the duration of hospital stay, an expected average of 1 week |
|
|
|
| Secondary | Usability: Coverage of the GlucoTab | Usability: coverage of the GlucoTab treatment during hospital stay | Diabetes therapy was performed according to the intended use of the GlucoTab system | Posted | Mean | Standard Deviation | percentage of hospital stay | Participants will be followed for the duration of hospital stay, an expected average of 1 week |
|
|
|
| 1 |
| 150 |
| 3 |
| 150 |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
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| AV Block Grad 3 | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
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| Haemorrhagic Gastritis | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
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| Antibiotic associated exanthema | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
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| Insult (Posteriorinfarction after intracardiac catheter) | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
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| Autoimmune hemolytic anemia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
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| Cholecystolithiasis | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
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| Aneurysma spurium right groin | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
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| NSTEMI | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
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| Spondylodicscitis LWS | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
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