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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Type 2 Diabetes Treated With Insulin
• Intervention / Treatment: Device: FreeStyle Libre 2 Flash Glucose Monitoring System

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 82
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pamela Reid, PhD; Phone Number: +441993863024; Email: pamela.reid@abbott.com

Study Locations

• Finland
  • Jämsä, Finland, 42100
    • Pihlajalinna Jämsä, Välikatu 1,
    • Contact: Henri Honka, MD, PhD
  • Tampere, Finland, 33100
    • Pihlajalinna Koskiklinikka, Hatanpäänvaltatie 1,
    • Contact: Elina Pimiä, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Intervention; FreeStyle Libre 2 Flash Glucose Monitoring System	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c	Change in HbA1c within group from baseline	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Frequency of hypoglycaemia events	CGM detected hypoglycaemia events defined as ≥15 minutes duration with glucose <3.9mmol/L (<70mg/dL)	3 months

Collaborators and Investigators

• Sponsor: Abbott Diabetes Care
• Investigators: Principal Investigator: Henri Honka, MD, PhD, Pihlajalinna, Jämsä

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: February 13, 2024
• First Submitted That Met QC Criteria: February 13, 2024
• First Posted (Actual): February 20, 2024

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 13, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: ADC-UK-PMS-23059

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No