Type 2 Diabetes Treated With Insulin
Conditions
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.
Interventions
Glucose sensors to be worn continuously for 3 months with data used to monitor and manage diabetes treatment and to inform lifestyle choices (diet and exercise)
Sponsors
Abbott Diabetes Care
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | 3 months | Change in HbA1c within group from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time in range (TIR) | 3 months | Time spent in glucose target range (TIR) 3.9 to 10.0 mmol/L (70 to 180 mg/dL) |
| Time above range (TAR) | 3 months | Time spent above glucose target range (TAR) \>10.0 mmol/L, \>13.9 mmol/L and \>16.7 mmol/L (\>180 mg/dL, \>250 mg/dL and \>300 mg/dL). |
| Time below range (TBR) | 3 months | Time spent below glucose target range (TBR) \<3.9 mmol/L and \<3.0 mmol/L (\<70 mg/dL and \<54 mg/dL). |
| Frequency of hypoglycaemia events | 3 months | CGM detected hypoglycaemia events defined as ≥15 minutes duration with glucose \<3.9mmol/L (\<70mg/dL) |
Countries
Italy
Outcome results
None listed