Glucose Monitoring, ContinuousGCRNCT07089979
Effectiveness of Glunovo Real-Time Continuous Glucose Monitoring in Adults With Type 2 Diabetes
A study testing Glunovo CGM device and BG-meter in people with Glucose Monitoring, Continuous, run by University of Milan at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Glucose Monitoring, Continuous
- What is being tested?
- Glunovo CGM device and BG-meter
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 260 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2024to 15 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Study of the Glunovo Real-Time Continuous Glucose Monitoring (CGM) Effectiveness on Metabolic Control in Patients With Type 2 Diabetes (T2D)
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).
Read the 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
- Being tested
- Glunovo CGM device, BG-meter
- Keywords
- Type 2 diabetes, Continous Glucose Monitoring, Glycemia
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glunovo CGM deviceDevice
Group 1 (Subjects that will use Glunovo CGM device) will be compared to Group 2 (subject that will use their glucometer)
BG-meterDevice
BG-meter
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Glunovo CGM device |
| subjects who will use their glucometer (control group) | Placebo comparator | Capillary glucose monitoring using fingerstick glucometer as per standard care. Receives: Device: BG-meter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start1 Jan 2024
- Primary completion1 Jul 2024
- Study completion15 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glucose Monitoring, ContinuousStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paolo Fiorina, MD, University of Milan
- Investigators
- Prof. Paolo Fiorina, Principal investigator, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07089979
- Sponsor's protocol ID
- 0023448/2024
- Acronym
- GCR
- Status last verified
- Jul 2025
- First submitted
- 9 Apr 2025
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41551204
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study of the Glunovo Real-Time Continuous Glucose Monitoring (CGM) Effectiveness on Metabolic Control in Patients With Type 2 Diabetes (T2D)
- ClinicalTrials.gov ID
- NCT07089979
- Acronym / sponsor ID
- GCR / 0023448/2024
- Conditions
- Glucose Monitoring, Continuous
- Keywords
- Type 2 diabetes, Continous Glucose Monitoring, Glycemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 15 Jul 2024 (actual)
- First posted
- 29 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| subjects who will use the device object of the interventional study | Experimental | Device: Glunovo CGM deviceParticipants randomized to this arm used the Glunovo Real-Time Continuous Glucose Monitoring (RT-CGM) system for 6 months. |
| subjects who will use their glucometer (control group) | Placebo comparator | Device: BG-meterCapillary glucose monitoring using fingerstick glucometer as per standard care. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glunovo CGM deviceGroup 1 (Subjects that will use Glunovo CGM device) will be compared to Group 2 (subject that will use their glucometer) | Device | subjects who will use the device object of the interventional study |
| BG-meterBG-meter | Device | subjects who will use their glucometer (control group) |
Primary outcome
changes in HbA1c levels
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Derived from this study: PubMed 41551204Lazzaroni 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof. Paolo Fiorina principal investigator
University of Milan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glunovo CGM device and BG-meter in people with Glucose Monitoring, Continuous, run by University of Milan at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in HbA1c levels (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07089979, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2025.