Initiation of Continuous Glucose Monitoring in Adults With Type 2 Diabetes Treated With Basal Insulin, in Italy

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Abbott

Status

Not yet enrolling

Conditions

Type 2 Diabetes Treated With Insulin

Treatments

Device: FreeStyle Libre 2 Flash Glucose Monitoring System

Study type

Interventional

Funder types

Industry

Identifiers

NCT06268808
ADC-UK-PMS-23058

Details and patient eligibility

About

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.

Full 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.

Enrollment

82 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

82 participants in 1 patient group

Intervention
Other group
Description:
FreeStyle Libre 2 Flash Glucose Monitoring System
Treatment:
Device: FreeStyle Libre 2 Flash Glucose Monitoring System

Trial contacts and locations

6

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Central trial contact

Pamela Reid, PhD

Data sourced from clinicaltrials.gov

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