This trial investigates the effects of continuous glucose monitoring (CGM) and an in-hospital diabetes team on in-hospital glycemic and clinical outcomes in patients with type 2 diabetes compared to standard glucose point-of-care (POC) testing and an in-hospital diabetes team.
In Denmark and worldwide, 15-20 % of hospitalised patients have diabetes mellitus. For most patients, diabetes is not the primary cause of admission. The patients are therefore under the care of non-diabetes specialists. Consequently, diabetes management can be inadequate resulting in hypoglycemia, hyperglycemia, and increased glycemic variability, which might increase patient mortality, morbidity, and length of hospital stay. Despite these challenges, a recent review concludes that in-hospital diabetes management is under-researched. Therefore, new in-hospital diabetes management strategies are greatly needed. Continuous glucose monitoring (CGM) might accommodate this need by providing 288 glucose readings per day compared to usual glucose point-of-care (POC) testing from finger-prick blood 3-5 times per day during admission. CGM glucose levels can be transmitted from the patient's room to a monitoring screen at the nursing stations. This setup is called telemetric CGM. Outstanding results on glycemic and clinical outcomes in an out-hospital setting exist, however, In-hospital CGM has been associated only with a clinically insignificant reduction of mean daily glucose levels and a small increased detection rate of hypoglycemia of glucose levels \<3 mmol/L (\<54 mg/dL) compared to POC. Reasons for this might be that an in-hospital diabetes team (i.e., educated diabetes nurses with CGM competencies) is imperative in achieving optimal use of telemetric CGM. This trial investigates if telemetric CGM and an in-hospital diabetes team improve patients' in-hospital glycemic and clinical outcomes compared to POC glucose testing and an in-hospital diabetes team
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
166
For CGM-arm subjects, glucose data are obtained by the CGM Dexcom G6 which via an iPhone SE 3 transmits data to the in-hospital diabetes team stations to be displayed on an iPad 9 10.2".
For the POC-arm subjects, glucose assessment is done by standard ward glucometer.
Copenhagen University Hospital - Herlev-Gentofte (Steno Diabetes Center Copenhagen)
Herlev, Denmark
Copenhagen University Hospital - North Zealand
Hillerød, Denmark
Time in range
Time in range (TIR) is defined as the percentage of time within glucose level of 3.9-10.0 mmol/L (70-180 mg/dL) measured by CGM.
Time frame: During hospitalization (up to 30 days)
Time in range per day 3.9-10.0 mmol/L (70-180 mg/dL)
Percentage of time in range assessed each day of inclusion; amount of time (hours and minutes).
Time frame: During hospitalization (up to 30 days)
Time above range (TAR) >10.0 mmol/L (>180 mg/dL)
Percentage of time above range; amount of time (hours and minutes).
Time frame: During hospitalization (up to 30 days)
Time above range (TAR) >13.9 mmol/L (>250 mg/dL)
Percentage of time above range; amount of time (hours and minutes).
Time frame: During hospitalization (up to 30 days)
Time below range (TBR) <3.9 mmol/L (<70 mg/dL)
Percentage of time below range; amount of time (hours and minutes)
Time frame: During hospitalization (up to 30 days)
Time below range (TBR) <3.0 (<54 mg/dL)
Percentage of time below range; amount of time (hours and minutes)
Time frame: During hospitalization (up to 30 days)
Standard deviation (SD) of all CGM glucose levels
mmol/L (mg/dL)
Time frame: During hospitalization (up to 30 days)
Coefficient of variation (CV)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
SD divided by mean glucose level
Time frame: During hospitalization (up to 30 days)
Mean glucose levels
mmol/L (mg/dL)
Time frame: During hospitalization (up to 30 days)
Hypoglycemia < 3.9 mmol/L (< 70 mg/dL)
mmol/L (mg/dL), duration ≥15 consecutive min.
Time frame: During hospitalization (up to 30 days)
Hypoglycemia (level 1) 3.0-3.8 mmol/L (54-69 mg/dL)
mmol/L (mg/dL), duration ≥15 consecutive min.
Time frame: During hospitalization (up to 30 days)
Hypoglycemia (level 2) < 3.0 mmol/L (<54 mg/dL)
mmol/L (mg/dL), duration ≥15 consecutive min.
Time frame: During hospitalization (up to 30 days)
Recurrent hypoglycemic events
Number; Reoccurring hypoglycemic events after the first episode of hypoglycemia.
Time frame: During hospitalization (up to 30 days)