Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
Conditions
Keywords
Continuous glucose monitoring, Hospitalization, Nutritional therapy
Brief summary
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).
Detailed description
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.
Interventions
OTHERisCGM group
As previously described
Sponsors
Aarhus University Hospital
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Expected length of hospital stay of at least 48 hours * Diagnosed with diabetes * Literate in Danish * Nutritional therapy using tube feeding or parenteral nutritional therapy * Admission to Department of Gastrointestinal Surgery or Department of Heart-, Lung-, and Vascular surgery, both at Aarhus University Hospital, Denmark.
Exclusion criteria
* Pregnancy * Patient unable to provide informed consent * Patient unable to use mobile phone for reading isCGM sensor * Known allergy to adhesives * Anticipated MRI during the hospital admission * Patients using CGM prior to hospital admission
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glucose time in range (3,9-10 mmol/l) (% pr day) | 2-14 days | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic variability; coefficient of variation (CV) (in %) | 2-14 days | CV when diabetes treatment is adjusted using isCGM compared with standard care using POC plasma glucose monitoring (PG) |
| Glycemic variability; standard deviation (SD) | 2-14 days | SD when diabetes treatment is adjusted using isCGM compared with standard care using POC plasma glucose monitoring (PG) |
| Time in hypoglycemia (<3 mmol/L) (%) | 2-14 days | Time in hypoglycemia (%) when diabetes treatment is adjusted using isCGM compared with standard care using POC plasma glucose monitoring (PG) |
| Time in hypoglycemia (<3,9 mmol/l) (%) | 2-14 days | Time in hypoglycemia (%) when diabetes treatment is adjusted using isCGM compared with standard care using POC plasma glucose monitoring (PG) |
| Mean glucose (mmol/l) isCGM versus POC PG | 2-14 days | Mean glucose (mmol/l) when diabetes treatment is adjusted using isCGM compared with standard care using POC plasma glucose monitoring (PG) |
| Time in hyperglycemia (>10 mmol/l) (%) | 2-14 days | Time in hyperglycemia when diabetes treatment is adjusted using isCGM compared with standard care using POC plasma glucose monitoring (PG) |
| Glucose out of range: Time in hypoglycemia and time in hyperglycemia (<3,9 and >10 mmol/l) (%) | 2-14 days | 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) |
| Daily total insulin dosage (IE) | 2-14 days | Daily total insulin dosage (IE) when diabetes treatment is adjusted using isCGM compared with standard care using POC plasma glucose monitoring (PG) |
| Time with active isCGM | 2-14 days | Time with active isCGM (%) in intervention group |
| Number of events with hypoglycemia (<3,9 mmol/l) (%) | 2-14 days | 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) |
Countries
Denmark
Outcome results
None listed