NCT07089979

Effectiveness of Glunovo Real-Time Continuous Glucose Monitoring in Adults With Type 2 Diabetes

A Randomized Study of the Glunovo Real-Time Continuous Glucose Monitoring (CGM) Effectiveness on Metabolic Control in Patients With Type 2 Diabetes (T2D)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 260 (actual)
• Sponsor: University of Milan · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Glucose Monitoring, Continuous

Interventions

Type	Name	Description
DEVICE	Glunovo CGM device	Group 1 (Subjects that will use Glunovo CGM device) will be compared to Group 2 (subject that will use their glucometer)
DEVICE	BG-meter	BG-meter

Timeline

• Start date: 2024-01-01
• Primary completion: 2024-07-01
• Completion: 2024-07-15
• First posted: 2025-07-29
• Last updated: 2025-07-29

Locations

1 site across 1 country: Italy