Trials Sponsors Conditions Drugs Pricing

Conditions

Glucose Monitoring, Continuous

Keywords

Type 2 diabetesContinous Glucose MonitoringGlycemia

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 deviceDevice

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-meterDevice

BG-meter

subjects who will use their glucometer (control group)

Eligibility Criteria

Age18 Years - 100 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (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:

Sponsors & Collaborators

University of Milan
Otherlead

Study Sites (1)

ASST Sacco Fatebenefratelli

Milan, Milan, 20154, Italy

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: 41551204DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

Prof. Paolo Fiorina
University of Milan
PRINCIPAL INVESTIGATOR

Enrollment

260 participants (actual enrollment reported by the registry).

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

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

subjects who will use the device object of the interventional study

subjects who will use their glucometer (control group)

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

subjects who will use the device object of the interventional study

subjects who will use their glucometer (control group)

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations