Type 2 DiabetesDIAFLASHNCT06098040
Long-Term Feedback Effect of FGM in Newly-Diagnosed T2D Patients
A study testing flash glucose monitoring continuous, capillary blood test and flash glucose monitoring intermittent in people with Type 2 Diabetes, run by Campus Bio-Medico University at 1 site in Italy.
Trial summary
This clinical trial aims to evaluate the educational training of 12-weeks using flash glucose monitoring (FGM) FreeStyle Libre2 (FSL2; Abbott Diabetes Care Inc., Alameda, CA, USA) in newly- diagnosed T2D subjects who are treated with metformin in term of sustained improvement in glycemic variability (TIR) after the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- flash glucose monitoring continuous, capillary blood test and flash glucose monitoring intermittent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteItaly
- Study dates
- 22 Sep 2023to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with type 2 diabetes mellitus ( according to the ADA Guidelines ) within the past 12 months
- Must be taking only metformin as glucose lowering treatments,
- Older than 18 years,
- Body Mass Index equal or greater than 25 Kg/m^2,
- Must be able to provide written informed consent .
Who cannot join
- diagnosis of type 1 diabetes;
- glycated hemoglobin exceeding 8.5%
- alcohol or drug abuse/dependency
- antidiabetic therapy other than metformin;
- pregnancy (on-going or planned during the study);
- severe illness (physical or mental health);
Show all 14Show fewer
- cognitive impairment;
- high dose steroids;
- hospitalized more than 2 times in past 12 months
- previous bariatric intervention or gastrectomy;
- pace maker use
- uncorrected vision impairment;
- already using a continuous glucose monitor or flash glucose monitor;
- any allergy to the component of the device.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Policlinico Universitario Campus Bio-Medico
Roma, Roma, 00100
About this study
Official title: Long-Term Feedback Effect of Flash Glucose Monitoring (Freestyle Libre2®) in Newly-Diagnosed Type 2 Diabetic Patients: a Randomized Monocentric Parallel-group Clinical Trial
This clinical trial aims to evaluate the educational training of 12-weeks using flash glucose monitoring (FGM) FreeStyle Libre2 (FSL2; Abbott Diabetes Care Inc., Alameda, CA, USA) in newly- diagnosed T2D subjects who are treated with metformin in term of sustained improvement in glycemic variability (TIR) after the discontinuation of FGM compared to self-monitoring of blood glucose (SMBG). This clinical trial also aim to explore which frequency of sensor wear at the diagnosis is more effective in achieving a sustained improvement in TIR after the FGM discontinuation over time.
Read the detailed description
Diabetes self-management represents the cornerstone of successful and cost-effective diabetes care, reducing the occurrence of complications, hospital admissions and readmission as well as estimated lifetime health care costs related to a lower risk for complications. Recent advances in diabetic technology may help to address some of these issues : Flash glucose monitoring (FGM) is a novel system of interstitial glucose monitoring intended to replace the capillary blood glucose measurement which proved to ameliorate glycemic variability and quality of life, beyond the good precision, increased time in range, and ease of wear. However, FGM is not currently used as an educational tool in patients with newly diagnosis of T2D who are not on insulin therapy.
Therefore, the rationale for this three-armed parallel group randomized controlled trial is that the continuous flow of data from FGM and the visual display of moment-to-moment glucose levels as a trend could provide real-time feedback also in newly T2D patients, assessing which frequency of sensor is superior in enhancing mindfulness and in ameliorating of glycemic control ,quality of life and well-being perception.
The entire study participation will span approximately 6 months and will be performed in the facilities of Fondazione Policlinico Campus Bio-Medico University of Rome enrolling 42 participants. The intervention phase will last 12 weeks followed by more 12 weeks in the follow-up phase. Each participant will have a screening visit ( week -4), a baseline visit ( week -2), a randomization visit (week 0) and three follow up visits at week 12 and 23 and 24 for all the groups.
Every group will wear also a blinded device (Free Style Libre Pro IQ) for registration of glicemyc variability at the baseline visit and a the end of the study ; group 1 will wear it also between intervention and follow-up phase ( weeks 11-12).
All patients will be asked to fill out a food diary at both the intervention and follow-up phases. A high glycemic index meal will also be administered during the randomization visit ( week 0) in order to record the emotional state of study subjects in response to postprandial glycemic values. Randomization will be performed following a ratio equal to 1:1:1 and blocked for gender.
The primary outcome of the study is the difference in the means of time in range (TIR) at weeks 23-24 adjusted for baseline phase values. Secondary endpoints include the difference in TIR assessed at weeks 11-12 among the three groups and within the three groups as well as difference in A1c, HOMA IR, weight, body composition and oxidative stress among the groups. Quality of life/well-being perception/mindfulness will be investigated at week 0, week 12 and week 24 through several questionnaires.
- Conditions
- Type 2 Diabetes
- Being tested
- flash glucose monitoring continuous, capillary blood test, flash glucose monitoring intermittent
- Keywords
- time in range, quality of life, bio feedback, flash glucose monitoring
- 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.
flash glucose monitoring continuousDevice
Group 2 (FGM continuous): will be asked to wear the sensor FreeStyle Libre2 for the FGM with the following frequency fashion continuously for the first 12 weeks and followed by 12 weeks testing as recommended by their usual provider.
capillary blood testDiagnostic test
Group 1 (SMBG): will be asked to test capillary blood glucose as recommended by subjects' usual provider for the first 12 weeks and followed by 12 weeks testing as recommended by their usual provider.
flash glucose monitoring intermittentDevice
Group 3 (FGM intermittent): will be asked to wear the sensor FreeStyle Libre2 for the FGM with the following frequency fashion 1 week off/2 weeks on for the first 12 weeks and followed by 12 weeks testing as recommended by their usual provider.
| Study group | Role | What they receive |
|---|---|---|
| group 2 - FGM continuous | Experimental | Patients will be asked to wear the sensor FreeStyle Libre2 continuously Receives: Device: flash glucose monitoring continuous |
| group 3 - FGM intermittent | Experimental | will be asked to wear the sensor FreeStyle Libre2 intermittently Receives: Device: flash glucose monitoring intermittent |
| group 1- SMBG | Active comparator | Patients will be asked to test capillary blood glucose as recommended by subjects' usual provider Receives: Diagnostic Test: capillary blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
time in range
difference in the means of time in range (TIR) registered at the weeks 23-24 phase through blinded device Free style Libre PRO-IQ, among the three groups and adjusted for baseline phase values.
Measured: 6 months
Secondary outcomes (7)
time in range
difference in the means of time in range (TIR) assessed at weeks 11-12 among the three groups,and adjusted for baseline phase values
Measured: 3 months
mindfulness
changes in eating mindfulness questionnaire score ( 28 items, each questions from 0 to 4 points) evaluated among the three groups and adjusted for baseline values. Higher scores on the mindful eating questionnaire overal, and on each of the categories ( Awareness , Distraction,Disinhibition,Emotional Response, External Cues)-has been associated with a lower body mass index and long-term weight maintenance
Measured: 3-6 months
Body Mass Index (BMI,kg/m^2)
changes in body mass (Kg) divided by the square of the body height (m), and is expressed in units of kg/m^2, resulting from mass in kilograms (kg) and height in metres (m) at weeks 12 and 24.
Measured: 6 months
Body Composition
changes in fat mass ( Kg ) and Fat free mass (Kg) assessed with bioelectrical Impedance Analysis adjusted for baseline values.
Measured: 6 months
Physical activity
evaluation of the types of intensity of physical activity in the previous 7 days assessed by th International Physical Activity Questionnaire ( IPAQ)- short form at week 24 among the three groups. Total physical activity will be expressed in MET ( Metabolic Equivalent of Task)-min/week and time spent sitting . MET< 700 is indicative of inactive person, MET above 2520 is indicative of very active person
Measured: 6 months
d-ROMs derivatives-reactive oxygen metabolites
changes in derivatives-reactive oxygen metabolites (d-ROMs, U.Carr) after the discontinuation of FGM compared with SMBG
Measured: 3-6 months
PAT plasma antioxidant capacity
changes in plasma antioxidant capacity ( PAT test, μmol/L ) after the discontinuation of FGM compared with SMBG
Measured: 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start22 Sep 2023
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- three-armed parallel group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Campus Bio-Medico University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Silvia Manfrini, Campus Bio-Medico University
- Investigators
- Silvia Manfrini, MD, Principal investigator, Campus Bio-Medico UniversityRossella Tozzi, MD PhD, Study chair, Campus Bio-Medico UniversityDario Tuccinardi, MD PhD, Study director, Campus Bio-Medico University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06098040
- Sponsor's protocol ID
- DIAFLASH
- Acronym
- DIAFLASH
- Status last verified
- Feb 2025
- First submitted
- 4 Oct 2023
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: IPD that underlie results in a publication on request
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Feedback Effect of Flash Glucose Monitoring (Freestyle Libre2®) in Newly-Diagnosed Type 2 Diabetic Patients: a Randomized Monocentric Parallel-group Clinical Trial
- ClinicalTrials.gov ID
- NCT06098040
- Acronym / sponsor ID
- DIAFLASH / DIAFLASH
- Conditions
- Type 2 Diabetes
- Keywords
- time in range, quality of life, bio feedback, flash glucose monitoring
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Campus Bio-Medico UniversityUniversity, hospital or other
- Study start
- 22 Sep 2023 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 24 Oct 2023 (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.
This clinical trial aims to evaluate the educational training of 12-weeks using flash glucose monitoring (FGM) FreeStyle Libre2 (FSL2; Abbott Diabetes Care Inc., Alameda, CA, USA) in newly- diagnosed T2D subjects who are treated with metformin in term of sustained improvement in glycemic variability (TIR) after the discontinuation of FGM compared to self-monitoring of blood glucose (SMBG). This clinical trial also aim to explore which frequency of sensor wear at the diagnosis is more effective in achieving a sustained improvement in TIR after the FGM discontinuation over time.
Detailed description
Diabetes self-management represents the cornerstone of successful and cost-effective diabetes care, reducing the occurrence of complications, hospital admissions and readmission as well as estimated lifetime health care costs related to a lower risk for complications. Recent advances in diabetic technology may help to address some of these issues : Flash glucose monitoring (FGM) is a novel system of interstitial glucose monitoring intended to replace the capillary blood glucose measurement which proved to ameliorate glycemic variability and quality of life, beyond the good precision, increased time in range, and ease of wear. However, FGM is not currently used as an educational tool in patients with newly diagnosis of T2D who are not on insulin therapy.
Therefore, the rationale for this three-armed parallel group randomized controlled trial is that the continuous flow of data from FGM and the visual display of moment-to-moment glucose levels as a trend could provide real-time feedback also in newly T2D patients, assessing which frequency of sensor is superior in enhancing mindfulness and in ameliorating of glycemic control ,quality of life and well-being perception.
The entire study participation will span approximately 6 months and will be performed in the facilities of Fondazione Policlinico Campus Bio-Medico University of Rome enrolling 42 participants. The intervention phase will last 12 weeks followed by more 12 weeks in the follow-up phase. Each participant will have a screening visit ( week -4), a baseline visit ( week -2), a randomization visit (week 0) and three follow up visits at week 12 and 23 and 24 for all the groups.
Every group will wear also a blinded device (Free Style Libre Pro IQ) for registration of glicemyc variability at the baseline visit and a the end of the study ; group 1 will wear it also between intervention and follow-up phase ( weeks 11-12).
All patients will be asked to fill out a food diary at both the intervention and follow-up phases. A high glycemic index meal will also be administered during the randomization visit ( week 0) in order to record the emotional state of study subjects in response to postprandial glycemic values. Randomization will be performed following a ratio equal to 1:1:1 and blocked for gender.
The primary outcome of the study is the difference in the means of time in range (TIR) at weeks 23-24 adjusted for baseline phase values. Secondary endpoints include the difference in TIR assessed at weeks 11-12 among the three groups and within the three groups as well as difference in A1c, HOMA IR, weight, body composition and oxidative stress among the groups. Quality of life/well-being perception/mindfulness will be investigated at week 0, week 12 and week 24 through several questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- three-armed parallel group
| Arm | Type | Receives |
|---|---|---|
| group 2 - FGM continuous | Experimental | Device: flash glucose monitoring continuousPatients will be asked to wear the sensor FreeStyle Libre2 continuously |
| group 3 - FGM intermittent | Experimental | Device: flash glucose monitoring intermittentwill be asked to wear the sensor FreeStyle Libre2 intermittently |
| group 1- SMBG | Active comparator | Diagnostic Test: capillary blood testPatients will be asked to test capillary blood glucose as recommended by subjects' usual provider |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed with type 2 diabetes mellitus ( according to the ADA Guidelines ) within the past 12 months
- Must be taking only metformin as glucose lowering treatments,
- Older than 18 years,
- Body Mass Index equal or greater than 25 Kg/m^2,
- Must be able to provide written informed consent .
Key exclusion criteria (14 listed)
- diagnosis of type 1 diabetes;
- glycated hemoglobin exceeding 8.5%
- alcohol or drug abuse/dependency
- antidiabetic therapy other than metformin;
- pregnancy (on-going or planned during the study);
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 |
|---|---|---|
| flash glucose monitoring continuousGroup 2 (FGM continuous): will be asked to wear the sensor FreeStyle Libre2 for the FGM with the following frequency fashion continuously for the first 12 weeks and followed by 12 weeks testing as recommended by their usual provider. | Device | group 2 - FGM continuous |
| capillary blood testGroup 1 (SMBG): will be asked to test capillary blood glucose as recommended by subjects' usual provider for the first 12 weeks and followed by 12 weeks testing as recommended by their usual provider. | Diagnostic test | group 1- SMBG |
| flash glucose monitoring intermittentGroup 3 (FGM intermittent): will be asked to wear the sensor FreeStyle Libre2 for the FGM with the following frequency fashion 1 week off/2 weeks on for the first 12 weeks and followed by 12 weeks testing as recommended by their usual provider. | Device | group 3 - FGM intermittent |
Primary outcome
time in range
Time frame: 6 months
difference in the means of time in range (TIR) registered at the weeks 23-24 phase through blinded device Free style Libre PRO-IQ, among the three groups and adjusted for baseline phase values.
7 secondary outcomes
time in range
Time frame: 3 months
mindfulness
Time frame: 3-6 months
Body Mass Index (BMI,kg/m^2)
Time frame: 6 months
Body Composition
Time frame: 6 months
Physical activity
Time frame: 6 months
d-ROMs derivatives-reactive oxygen metabolites
Time frame: 3-6 months
PAT plasma antioxidant capacity
Time frame: 3-6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
- Individual participant dataSharing planned: Yes. IPD that underlie results in a publication on request
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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.
Silvia Manfrini, MD principal investigator
Campus Bio-Medico University
Rossella Tozzi, MD PhD study chair
Campus Bio-Medico University
Dario Tuccinardi, MD PhD study director
Campus Bio-Medico University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing flash glucose monitoring continuous, capillary blood test and flash glucose monitoring intermittent in people with Type 2 Diabetes, run by Campus Bio-Medico University 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 5 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 18 Feb 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
time in range (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Feb 2025.