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

Type 2 Diabetes Treated With Insulin Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06268808
• Other study ID #: ADC-UK-PMS-23058
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2024
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Abbott Diabetes Care
• Contact: Pamela Reid, PhD
• Phone: +441993863024
• Email: pamela.reid[@]abbott.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 82
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Treated With Insulin

Intervention

Device:
• FreeStyle Libre 2 Flash Glucose Monitoring System
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)

Locations

Country	Name	City	State
Italy	Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari	Bari
Italy	Università degli Studi di Catania, Ospedale Garibaldi-Nesima, U.O. Endocrinologia	Catania
Italy	Università degli Studi di Catania, Ospedale Garibaldi-Nesima, U.O.C. Medicina Interna	Catania
Italy	Azienda Ospedaliera - Università di Padova	Padova
Italy	Azienda Ospedaliero-Universitaria di Parma	Parma
Italy	La Sapienza Università di Roma, AOU Policlinico Umberto I	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Diabetes Care

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c	Change in HbA1c within group from baseline	3 months
Secondary	Time in range (TIR)	Time spent in glucose target range (TIR) 3.9 to 10.0 mmol/L (70 to 180 mg/dL)	3 months
Secondary	Time above range (TAR)	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 months
Secondary	Time below range (TBR)	Time spent below glucose target range (TBR) <3.9 mmol/L and <3.0 mmol/L (<70 mg/dL and <54 mg/dL).	3 months
Secondary	Frequency of hypoglycaemia events	CGM detected hypoglycaemia events defined as =15 minutes duration with glucose <3.9mmol/L (<70mg/dL)	3 months