Diabetes Mellitus, Type 1
Conditions
Keywords
flash glucose monitoring, HbA1c
Brief summary
Aim of the study is to evaluate efficacy of freestyle Libre system (flash glucose monitoring) in real life in term of Glycated Haemoglobin reduction and acceptance of the system evaluated through validated questionnaires after 3 and 6 months of device's use.
Detailed description
Freestyle Libre is a new technology developed to monitor glycemic values in diabetic patients. The system is available in Italy from 2014 but in Veneto region reimbursement for insulin treated diabetic patients is available from august 2017. International trial (for example Impact trial) demonstrated efficacy of the system (reduction of the time spent in hypoglycemia). Aim of this study is to evaluate efficacy in real life in term of glycated haemoglobin (HbA1c) reduction. The investigators will enrollee in this trial all type 1 diabetic patients that will start to use the system, on the basis of clinicians decisions and reimbursement criteria. Investigators will evaluate changes in HbA1c and changes in hypoglycameia fear and therapy acceptance through validated questionnaires after 3 and 6 months of system use
Interventions
DEVICEType 1 diabetic patients freestyle libre
patients selected to use freestyle libre
Sponsors
University of Padova
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male and female participants of at least 18 years of age * Diagnosis of type 1 diabetes mellitus (diagnosed according to World Health Organization criteria) for at least 1 year * Availability to wear Freestyle Libre sensor * Signature of informed consent
Exclusion criteria
* Pregnancy, breastfeeding, intention to undergo pregnancy * Known allergies to skin patches or disinfectants used during the study. * Skin lesions, irritation, redness, edema in sites where sensors can be applied, as this might interfere with sensor's placement * Use of drugs that may interfere with glucose metabolism (such as steroids) unless they are chronic therapies whose dosage has remained stable over the past 3 months and is expected to remain stable during the study period. * Severe medical or psychological conditions, which, in the opinion of the medical team, may compromise patients' safety while using freestyle LIbre sensor * Patients enrolled in other clinical trials. * patients that usually wear other continuous glucose monitoring system
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | after 3 and 6 months | changes in HbA1c values |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| changes in hypoglycemia fear | after 3 and 6 months | Evaluation of hypoglycemia fear through a validated questionnaires, Hypoglycemic Fear Survey (HFS-II). The questionnaires is composed by 33 questions with a Linkert Scale (0-4) |
| changes in therapy satisfaction | after 3 and 6 months | Evaluation of changes in therapy satisfaction through a validated questionnaires, Diabetes Treatment Satisfaction Questionnaire (DTSQ). The questionnaires is composed by 8 questions with a Linkert Scale (0-6) |
| hypoglycemic episodes | after 3 and 6 months | number of hypoglycemic episodes |
| weight | after 3 and 6 months | changes in weight (Kg) |
| insulin use | after 3 and 6 months | changes in insulin dose (unit/Kg) |
Countries
Italy
Outcome results
None listed