Type 2 Diabetes Clinical Trial
— DIAFLASHOfficial 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.
Status | Recruiting |
Enrollment | 42 |
Est. completion date | September 27, 2024 |
Est. primary completion date | March 27, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Italy | Fondazione Policlinico Universitario Campus Bio-Medico | Roma |
Lead Sponsor | Collaborator |
---|---|
Campus Bio-Medico University |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 6 months | |
Secondary | 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 | 3 months | |
Secondary | 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 | 3-6 months | |
Secondary | 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. | 6 months | |
Secondary | Body Composition | changes in fat mass ( Kg ) and Fat free mass (Kg) assessed with bioelectrical Impedance Analysis adjusted for baseline values. | 6 months | |
Secondary | 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 | 6 months | |
Secondary | d-ROMs derivatives-reactive oxygen metabolites | changes in derivatives-reactive oxygen metabolites (d-ROMs, U.Carr) after the discontinuation of FGM compared with SMBG | 3-6 months | |
Secondary | PAT plasma antioxidant capacity | changes in plasma antioxidant capacity ( PAT test, µmol/L ) after the discontinuation of FGM compared with SMBG | 3-6 months |
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