Clinical trial NCT06268808: Initiation of Continuous Glucose Monitoring in Adults With Type 2 Diabetes Treated With Basal Insulin, in Italy
Official title: Initiation of Continuous Glucose Monitoring in Adults With Type 2 Diabetes Treated With Basal Insulin, in Italy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 2 Diabetes Treated With Insulin
Lead sponsor: Abbott Diabetes Care
Sponsor class: INDUSTRY
First posted: 2024-02-20
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: HbA1c
timeFrame: 3 months
Secondary outcomes:
measure: Time in range (TIR)
timeFrame: 3 months
measure: Time above range (TAR)
timeFrame: 3 months
measure: Time below range (TBR)
timeFrame: 3 months
measure: Frequency of hypoglycaemia events
timeFrame: 3 months
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
city: Catania
country: Italy
facility: Università degli Studi di Catania, Ospedale Garibaldi-Nesima, U.O. Endocrinologia
city: Catania
country: Italy
facility: Università degli Studi di Catania, Ospedale Garibaldi-Nesima, U.O.C. Medicina Interna
city: Livorno
country: Italy
facility: ASL Toscana Nord Ovest
city: Parma
country: Italy
facility: Azienda Ospedaliero-Universitaria di Parma
city: Rome
country: Italy
facility: La Sapienza Università di Roma, AOU Policlinico Umberto I
Study officials:
affiliation: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
name: Francesco Giorgino, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: