Diabetes Mellitus, Type 1NCT03703999
Freestyle Libre Use in Real Life: Efficacy and Acceptance
An observational study of Diabetes Mellitus, Type 1, run by University of Padova at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Type 1 diabetic patients freestyle libre
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2018to 1 Sep 2019
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: type 1 diabetic patients selected by clinicians to start Freestyle Libre use
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Acceptance of Freestyle Libre Abbott Use in Real Life in Type 1 Diabetic Patients
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.
Read the 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
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Type 1 diabetic patients freestyle libre
- Keywords
- flash glucose monitoring, HbA1c
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Type 1 diabetic patients freestyle libreDevice
patients selected to use freestyle libre
| Study group | Role | What they receive |
|---|---|---|
| type 1 diabetic patients freestyle Libre | group of type 1 diabetic patients that will be selected to use Freestyle libre on the basis of clinicians decisions and reimbursement criteria Receives: Device: Type 1 diabetic patients freestyle libre |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
changes in HbA1c values
Measured: after 3 and 6 months
Secondary outcomes (5)
changes in hypoglycemia fear
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)
Measured: after 3 and 6 months
changes in therapy satisfaction
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)
Measured: after 3 and 6 months
hypoglycemic episodes
number of hypoglycemic episodes
Measured: after 3 and 6 months
weight
changes in weight (Kg)
Measured: after 3 and 6 months
insulin use
changes in insulin dose (unit/Kg)
Measured: after 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2018
- Study start1 Jun 2018
- Primary completion1 Apr 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniela Bruttomesso, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03703999
- Sponsor's protocol ID
- 4465/AO/18
- Status last verified
- Mar 2020
- First submitted
- 20 Sep 2018
- Last updated
- 27 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Acceptance of Freestyle Libre Abbott Use in Real Life in Type 1 Diabetic Patients
- ClinicalTrials.gov ID
- NCT03703999
- Acronym / sponsor ID
- 4465/AO/18
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- flash glucose monitoring, HbA1c
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 12 Oct 2018 (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.
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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| type 1 diabetic patients freestyle Libre | – | Device: Type 1 diabetic patients freestyle libregroup of type 1 diabetic patients that will be selected to use Freestyle libre on the basis of clinicians decisions and reimbursement criteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- type 1 diabetic patients selected by clinicians to start Freestyle Libre use
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Type 1 diabetic patients freestyle librepatients selected to use freestyle libre | Device | type 1 diabetic patients freestyle Libre |
Primary outcome
HbA1c
Time frame: after 3 and 6 months
changes in HbA1c values
5 secondary outcomes
changes in hypoglycemia fear
Time frame: after 3 and 6 months
changes in therapy satisfaction
Time frame: after 3 and 6 months
hypoglycemic episodes
Time frame: after 3 and 6 months
weight
Time frame: after 3 and 6 months
insulin use
Time frame: after 3 and 6 months
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 27 Mar 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 1, run by University of Padova 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 4 inclusion and 7 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 27 Mar 2020. 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?
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?
HbA1c (time frame: after 3 and 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 27 Mar 2020.