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

NCT07089979 | Completed

• 1 other identifier: 0023448/2024
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

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).

Conditions

Glucose Monitoring, Continuous

Keywords

Type 2 diabetes; Continous Glucose Monitoring; Glycemia

Outcome Measures

Primary Outcomes (1)

• 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

  6 months

Study Arms (2)

subjects who will use the device object of the interventional study

EXPERIMENTAL

Participants randomized to this arm used the Glunovo Real-Time Continuous Glucose Monitoring (RT-CGM) system for 6 months.

Device: Glunovo CGM device

subjects who will use their glucometer (control group)

PLACEBO COMPARATOR

Capillary glucose monitoring using fingerstick glucometer as per standard care.

Device: BG-meter

Interventions

Glunovo CGM device DEVICE

Group 1 (Subjects that will use Glunovo CGM device) will be compared to Group 2 (subject that will use their glucometer)

subjects who will use the device object of the interventional study

BG-meter DEVICE

BG-meter

subjects who will use their glucometer (control group)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Milan: lead

Study Sites (1)

ASST Sacco Fatebenefratelli

Milan, Milan, 20154, Italy

Location

Related Publications (1)

• Lazzaroni E, Cimino V, Gandolfi A, Tinari C, Bucciarelli L, Morpurgo P, Ben Nasr M, Fiorina RM, Pastore I, Baruffaldi L, Losurdo F, D'Addio F, Zuccotti GV, Montefusco L, Rossi A, Lunati ME, Fiorina P. A Randomized Study of the Glunovo Real-time CGM Effectiveness in Individuals With Poorly Controlled Type 2 Diabetes. J Endocr Soc. 2026 Jan 12;10(2):bvaf165. doi: 10.1210/jendso/bvaf165. eCollection 2026 Feb.

  PMID: 41551204 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Prof. Paolo Fiorina

  University of Milan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: July 29, 2025
• Study Start: January 1, 2024
• Primary Completion: July 1, 2024
• Study Completion: July 15, 2024
• Last Updated: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)