Effect on HbA1c of the Initiation of CGM in Adults With Type 2 Diabetes Treated With Basal Insulin in Finland

Type 2 Diabetes Treated With Insulin Clinical Trial

Official title:

The Effect on HbA1c of the Initiation of Continuous Glucose Monitoring in Adults With Type 2 Diabetes Treated With Basal Insulin in Finland

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06268821
• Other study ID #: ADC-UK-PMS-23059
• Status: Recruiting
• Phase: N/A
• Start date: April 2, 2024
• Est. completion date: January 2025

Study information

• Verified date: January 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 Finland. 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: Recruiting
• Enrollment: 82
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• 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
Finland	Pihlajalinna Jämsä, Välikatu 1,	Jämsä
Finland	Pihlajalinna Koskiklinikka, Hatanpäänvaltatie 1,	Tampere

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Diabetes Care

Country where clinical trial is conducted

Finland, 

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