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

Launched by ABBOTT DIABETES CARE · Feb 13, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how starting to use a new glucose monitoring system called FreeStyle Libre 2 impacts blood sugar control in adults with type 2 diabetes who are being treated with basal insulin. The study will last for three months, and researchers want to see if using this monitoring system helps improve a key blood test result called HbA1c, which reflects average blood sugar levels over time.

To participate, individuals must be between 18 and 75 years old and have been diagnosed with type 2 diabetes for at least a year. They should be using a basal insulin injection, either alone or with other diabetes medications, for at least three months and have specific blood sugar levels within a certain range. Participants will not be eligible if they are on certain types of insulin, are pregnant or breastfeeding, or are involved in other studies that could affect their blood sugar management. Those who join the study can expect to use the glucose monitoring system and provide information about their blood sugar levels over the trial period.

Gender

ALL

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.