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This prospective, non-randomized, non-controlled, interventional study will determine whether the Roche automated bolus caclulator (ABC) reduces post-meal hyperglycemia better than the competitor's ABC without causing significant hypoglycemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Accu-Chek Combo Kit mg DE/de | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| To compare the difference between the self-monitoring blood glucose (SMBG) value achieved at 6 hours after meals with induced post-prandial hyperglycemia and the mean target value of 110 mg/dL. Target post-prandial range is 80-140 mg/dL. | 6 hours after meal |
| Measure | Description | Time Frame |
|---|---|---|
| To compare the absolute difference between the SMBG value and the target value between the calculators | 6 hours after meal | |
| To compare theto compare the relative difference (multiplied by 100) between the SMBG value and the target value between the calculators |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bettina Petersen | Roche Diagnostics GmbH / Diabetes Care | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ulm | 89081 | Germany |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| 6 hours after meal |
| To compare the absolute relative difference (RAD, multiplied by 100) between the SMBG value and the target value between the calculators | 6 hours after meal |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |