Clinical trial NCT06098040: Long-Term Feedback Effect of FGM in Newly-Diagnosed T2D Patients
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Keywords: time in range
quality of life
bio feedback
flash glucose monitoring
Lead sponsor: Campus Bio-Medico University
Sponsor class: OTHER
First posted: 2023-10-24
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: three-armed parallel group
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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 .

Exclusion Criteria:

* 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);
* 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.

Primary outcomes:
measure: time in range
timeFrame: 6 months
Secondary outcomes:
measure: time in range
timeFrame: 3 months
measure: mindfulness
timeFrame: 3-6 months
measure: Body Mass Index (BMI,kg/m^2)
timeFrame: 6 months
measure: Body Composition
timeFrame: 6 months
measure: Physical activity
timeFrame: 6 months
measure: d-ROMs derivatives-reactive oxygen metabolites
timeFrame: 3-6 months
measure: PAT plasma antioxidant capacity
timeFrame: 3-6 months
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Campus Bio-Medico
Study officials:
affiliation: Campus Bio-Medico University
name: Silvia Manfrini, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Campus Bio-Medico University
name: Rossella Tozzi, MD PhD
role: STUDY_CHAIR
affiliation: Campus Bio-Medico University
name: Dario Tuccinardi, MD PhD
role: STUDY_DIRECTOR
References: