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| Name | Class |
|---|---|
| Aarhus University Hospital | OTHER |
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The aim of the study is to investigate the applicability of a Flash glucose monitoring sensor (Freestyle Libre, isCGM) for in-hospital glucose monitoring in patients with diabetes requiring nutritional therapy (tube feeding or parenteral feeding).
All patients who meet study criteria will be invited to participate in the study. All patients included in the study will be followed by a trained clinical diabetes specialist and a trained study nurse (study personnel) for glucose management during their hospitalization. All patients included in the study will receive a Freestyle Libre isCGM. The patients will be randomized to control (blinded isCGM glucose values to patient and study personnel and POC (point-of-care) plasma glucose will be used for adjusting diabetes treatment) or intervention (isCGM blood glucose values will be used to aid with glucose management during the hospitalization). The study personnel will work with the patient's care team.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| isCGM-arm | Active Comparator | isCGM (intermittently scanned continuous glucose monitor) data obtained from a FreeStyle Libre Flash continuous glucose monitoring system will be viewed real-time and used to adjust diabetes treatment |
|
| POC-arm | No Intervention | POC glucose readings are used to adjust diabetes treatment. CGM data from the Freestyle Libre monitor are blinded to all and only gathered for comparison purposes to intervention group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| isCGM group | Other | As previously described |
|
| Measure | Description | Time Frame |
|---|---|---|
| Glucose time in range (3,9-10 mmol/l) (% pr day) | Glucose time in range (3,9-10 mmol/l) when diabetes treatment is adjusted using isCGM compared with standard care using POC plasma glucose monitoring (PG) (% pr day) | 2-14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Mean glucose (mmol/l) isCGM versus POC PG | Mean glucose (mmol/l) when diabetes treatment is adjusted using isCGM compared with standard care using POC plasma glucose monitoring (PG) | 2-14 days |
| Glycemic variability; coefficient of variation (CV) (in %) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julie Støy, MD | Aarhus University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus university hospital | Aarhus | 8200 | Denmark |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003924 | Diabetes Mellitus, Type 2 |
| 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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CV when diabetes treatment is adjusted using isCGM compared with standard care using POC plasma glucose monitoring (PG) |
| 2-14 days |
| Glycemic variability; standard deviation (SD) | SD when diabetes treatment is adjusted using isCGM compared with standard care using POC plasma glucose monitoring (PG) | 2-14 days |
| Time in hypoglycemia (<3 mmol/L) (%) | Time in hypoglycemia (%) when diabetes treatment is adjusted using isCGM compared with standard care using POC plasma glucose monitoring (PG) | 2-14 days |
| Time in hypoglycemia (<3,9 mmol/l) (%) | Time in hypoglycemia (%) when diabetes treatment is adjusted using isCGM compared with standard care using POC plasma glucose monitoring (PG) | 2-14 days |
| Number of events with hypoglycemia (<3,9 mmol/l) (%) | Number of events with hypoglycemia per day (<3,9 mmol/L for >15 minutes) when diabetes treatment is adjusted using isCGM compared with standard care using POC plasma glucose monitoring (PG) | 2-14 days |
| Time in hyperglycemia (>10 mmol/l) (%) | Time in hyperglycemia when diabetes treatment is adjusted using isCGM compared with standard care using POC plasma glucose monitoring (PG) | 2-14 days |
| Glucose out of range: Time in hypoglycemia and time in hyperglycemia (<3,9 and >10 mmol/l) (%) | Glucose out of range: Time in hypoglycemia and time in hyperglycemia (<3,9 and >10 mmol/l) (%) when diabetes treatment is adjusted using isCGM compared with standard care using POC plasma glucose monitoring (PG) | 2-14 days |
| Daily total insulin dosage (IE) | Daily total insulin dosage (IE) when diabetes treatment is adjusted using isCGM compared with standard care using POC plasma glucose monitoring (PG) | 2-14 days |
| Time with active isCGM | Time with active isCGM (%) in intervention group | 2-14 days |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |