NCT03445377

Comparison of Real-tiMe ContInuous gLucosE moNitoriNg With Self-monitorIng of Blood Glucose in Young AduLts With Type 1 diabeteS

An Open-label, Single-centre, Randomised, Cross-over Design Feasibility Study to Assess the Efficacy of Real-time Continuous Glucose Monitoring in Comparison With Self-monitoring of Blood Glucose in Young Adults and Adolescents With Type 1 Diabetes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Manchester University NHS Foundation Trust · Other Government
• Sex: All
• Age: 16 Years – 297 Months
• Healthy volunteers: Not accepted

Summary

The main objective of this study is to determine whether real-time continuous glucose monitoring (CGM) for 8 weeks is more efficacious compared to self-monitoring of blood glucose (SMBG) in young adults with type 1 diabetes.

Detailed description

This is an open-label, multi-centre, randomised, crossover design study, involving a 2-week run-in period with blinded CGM, followed by two 8 weeks study periods during which subjects will monitor daily glucose levels either with real-time CGM or SMBG in random order. Subjects will wear a blinded CGM for a 3-week period during the Control phase. A total of up to 40 subjects (aiming for 30 completed subjects) aged 16 to 24 years with T1D will be recruited through diabetes clinics and other established methods in participating centres. Subjects who drop out of the study within the first 2 weeks of the first intervention period will be replaced. Subjects will receive appropriate training in the use of real-time CGM. Subjects will have regular contact with the study team during the study. The primary outcome is time spent in target range between 3.9 and 10.0 mmol/L as recorded by CGM. Secondary outcomes are the HbA1c, time spent with glucose levels above and below target, as recorded by CGM, and other CGM-based metrics. Measures of subject's responses in terms of daily diabetes management, diabetes distress and diabetes technology use and acceptance will also be evaluated in this study.

Conditions

• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
DEVICE	Real-time continuous glucose monitoring	Subjects randomised to Real-time continuous glucose monitoring will be given a Dexcom G5 or similar, training on its use, and HbA1c measurements taken at the start and end of the study. They will also be given validated questionnaires to complete.
DEVICE	Self-monitoring of blood glucose	Subjects randomised to self monitoring of blood glucose will be given a masked CGM which will be applied for one week, during Week 1, 4 and 8. HbA1c measurements will be taken at the start and end of the study. They will also be given validated questionnaires to complete.

Timeline

• Start date: 2018-07-16
• Primary completion: 2020-06-28
• Completion: 2020-06-28
• First posted: 2018-02-26
• Last updated: 2021-03-16

Locations

1 site across 1 country: United Kingdom