An interventional study of Glunovo CGM device and BG-meter in Glucose Monitoring, Continuous, sponsored by University of Milan. Completed at 1 site in Italy. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-07-29.
Sponsored by University of Milan · Not applicable, Interventional, and Other
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.
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's enrollment of 260 is above the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →University of Milan is the lead sponsor of 177 studies on the registry; 27 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Diagnosis of Type 2 Diabetes (T2D) Age above 18 years Glycated Hemoglobin (HbA1c) between 7.5% and 11% On basal-bolus insulin, basal-oral combination therapy, or non-insulin antidiabetic therapy
Exclusion Criteria:
Pregnancy HbA1c > 11% or \< 7.5% Diagnosis of Type 1 Diabetes, Latent Autoimmune Diabetes in Adults (LADA), Maturity Onset Diabetes of the Young (MODY), or other forms of hyperglycemia
Participants randomized to this arm used the Glunovo Real-Time Continuous Glucose Monitoring (RT-CGM) system for 6 months.
Device: Glunovo CGM device
Capillary glucose monitoring using fingerstick glucometer as per standard care.
Device: BG-meter
Group 1 (Subjects that will use Glunovo CGM device) will be compared to Group 2 (subject that will use their glucometer)
BG-meter
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
Plan to share: No
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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University of Milan