Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Active Not Recruiting NCT05944432

CGM Use in Adults With Type 2 Diabetes on Basal Insulin

Conditions: Diabetes Mellitus, Type 2

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 469
Sponsor: Abbott Diabetes Care

Location: Tameside General Hospital Ashton-under-Lyne

Summary

A prospective multi-centre, open-label, two arm, parallel design, superiority, pragmatic, randomised controlled trial, over an 8-month period. The purpose of this study is to determine whether continuous glucose monitoring using FreeStyle Libre 3 will improve HbA1c compared to SMBG over 16 weeks in adults with sub-optimally controlled (HbA1c 7.5-11%) Type 2 diabetes on basal therapy. Following completion of the 8-month period for all participants, an optional non-interventional follow-up period will assess glycaemic control and treatment patterns over 24 months.

Eligibility Criteria

Inclusion Criteria: * Aged 18 years or over. * Type 2 diabetes diagnosis for ≥1 year prior to enrolment. * Type 2 diabetes treated with a basal insulin injection regimen and SGLT2 inhibitor and/or GLP-1. * Screening HbA1c ≥59 mmol/mol to ≤97 mmol/mol (≥7.5% and ≤11.0%, inclusive). 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. * A female participant who is pregnant. * A breastfeeding female participant. * Bariatric surgical procedure within the past 12 months or is planning/scheduled for bariatric surgery within the study duration.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05944432). StuddyBuddy aggregates publicly available trial information.