Initiation of Continuous Glucose Monitoring in Adults With Type 2 Diabetes Treated With Basal Insulin, in Italy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Abbott Diabetes Care
- Enrollment
- 90
- Locations
- 16
- Primary Endpoint
- HbA1c
Study Overview
Brief Summary
The goal of this clinical study is to determine the impact of starting the use of the FreeStyle Libre 2 glucose monitoring system, over a three month period, on HbA1c in adults with type 2 diabetes treated with a basal insulin regimen.
Detailed Description
This is a post-market, multi-centre, prospective, interventional single arm study in Italy.
Participants will use the FreeStyle Libre 2 Flash Glucose Monitoring System, according to the labelling, to monitor their glucose for approximately 3 months. Additional therapies may be introduced, if clinically indicated, based on review of the participant's clinical data and in line with national guidance.
HbA1c will be tested at the start and end of the study for primary endpoint analysis.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Aged ≥18 to ≤ 75 years.
- •Type 2 diabetes diagnosis ≥1 year prior to enrolment.
- •Type 2 diabetes treated with a basal insulin injection regimen with or without other antihyperglycaemic therapy at enrolment.
- •Current glucose lowering treatment regimen has been established for at least 3 months prior to enrolment.
- •Screening HbA1c ≥59 mmol/mol to ≤108 mmol/mol (≥7.5% and ≤12.0%, inclusive), within the last 60 days.
Exclusion Criteria
- •Participant is currently prescribed prandial or pre-mixed (biphasic) insulin at enrolment.
- •Currently participating in another study that could affect glucose measurements or glucose management.
- •Currently receiving dialysis treatment or receives dialysis during the study.
- •A female participant who is pregnant.
- •A breastfeeding female participant.
Arms & Interventions
Intervention
FreeStyle Libre 2 Flash Glucose Monitoring System
Intervention: FreeStyle Libre 2 Flash Glucose Monitoring System (Device)
Outcomes
Primary Outcomes
HbA1c
Time Frame: 3 months
Change in HbA1c within group from baseline
Secondary Outcomes
- Frequency of hypoglycaemia events(3 months)
- Time below range (TBR)(3 months)
- Time in range (TIR)(3 months)
- Time above range (TAR)(3 months)