The goal of this clinical study is to determine the impact of starting the use of the FreeStyle Libre 2 glucose monitoring system, over a three month period, on HbA1c in adults with type 2 diabetes treated with a basal insulin regimen.
This is a post-market, multi-centre, prospective, interventional single arm study in Finland. Participants will use the FreeStyle Libre 2 Flash Glucose Monitoring System, according to the labelling, to monitor their glucose for approximately 3 months. Additional therapies may be introduced, if clinically indicated, based on review of the participant's clinical data and in line with national guidance. HbA1c will be tested at the start and end of the study for primary endpoint analysis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
11
Glucose sensors to be worn continuously for 3 months with data used to monitor and manage diabetes treatment and to inform lifestyle choices (diet and exercise)
Pihlajalinna Jämsä, Välikatu 1,
Jämsä, Finland
Pihlajalinna Koskiklinikka, Hatanpäänvaltatie 1,
Tampere, Finland
HbA1c
Change in HbA1c within group from baseline
Time frame: 3 months
Time in range (TIR)
Time spent in glucose target range (TIR) 3.9 to 10.0 mmol/L (70 to 180 mg/dL)
Time frame: 3 months
Time above range (TAR)
Time spent above glucose target range (TAR) \>10.0 mmol/L, \>13.9 mmol/L and \>16.7 mmol/L (\>180 mg/dL, \>250 mg/dL and \>300 mg/dL).
Time frame: 3 months
Time below range (TBR)
Time spent below glucose target range (TBR) \<3.9 mmol/L and \<3.0 mmol/L (\<70 mg/dL and \<54 mg/dL).
Time frame: 3 months
Frequency of hypoglycaemia events
CGM detected hypoglycaemia events defined as ≥15 minutes duration with glucose \<3.9mmol/L (\<70mg/dL)
Time frame: 3 months
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