The study aims to evaluate the effectiveness of the novel Real-Time Continuous Glucose Monitoring (RT-CGM) system "Glunovo" in improving glycemic control and patient-reported outcomes in individuals with poorly controlled Type 2 Diabetes (T2D).
This is a prospective, open-label, randomized controlled trial involving 165 adult patients with T2D recruited at the Fatebenefratelli-Sacco Hospital in Milan. Participants were randomized in a 1:1 ratio to either the intervention group (RT-CGM with Glunovo) or the control group (standard Self-Monitoring of Blood Glucose \[SMBG\] using conventional glucometers). The primary outcome is the change in Glycated Hemoglobin (HbA1c) levels after 6 months of follow-up. Secondary outcomes include Continuous Glucose Monitoring (CGM)-derived metrics-such as Glucose Management Indicator (GMI), Time in Range (TIR), Time Above Range (TAR), and Time Below Range (TBR)-as well as patient well-being, assessed using the WHO-5 Well-Being Index and a satisfaction scale. The study is designed to assess whether the Glunovo RT-CGM system can support better metabolic control and improve patient experience compared to conventional SMBG methods.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
260
Group 1 (Subjects that will use Glunovo CGM device) will be compared to Group 2 (subject that will use their glucometer)
BG-meter
ASST Sacco Fatebenefratelli
Milan, Milan, Italy
changes in HbA1c levels
The primary outcome of the study was to evaluate changes in HbA1c levels after 6 months of RT-CGM use compared to baseline in both the intervention and control groups
Time frame: 6 months
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