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OpenTrials
Completed

NCT Number: NCT06268808

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

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.

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Key information

Conditions

Type 2 Diabetes Treated With Insulin

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari, Bari, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FreeStyle Libre 2 Flash Glucose Monitoring System

Device

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)

Primary outcomes

  1. HbA1c

    Time frame: 3 months

    Change in HbA1c within group from baseline

Secondary outcomes

  1. Time in range (TIR)

    Time frame: 3 months

    Time spent in glucose target range (TIR) 3.9 to 10.0 mmol/L (70 to 180 mg/dL)

  2. Time above range (TAR)

    Time frame: 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).

  3. Time below range (TBR)

    Time frame: 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).

  4. Frequency of hypoglycaemia events

    Time frame: 3 months

    CGM detected hypoglycaemia events defined as ≥15 minutes duration with glucose <3.9mmol/L (<70mg/dL)

Sponsors and collaborators

Lead sponsor

Abbott Diabetes Care

Industry

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 20, 2024
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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