Glucose Monitoring, Continuous
Conditions
Keywords
Type 2 diabetes, Continous Glucose Monitoring, Glycemia
Brief 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.
Interventions
DEVICEGlunovo CGM device
Group 1 (Subjects that will use Glunovo CGM device) will be compared to Group 2 (subject that will use their glucometer)
DEVICEBG-meter
BG-meter
Sponsors
University of Milan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| changes in HbA1c levels | 6 months | 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 |
Countries
Italy
Outcome results
None listed