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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
32
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.
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.
Manchester Diabetes Centre, Manchester University NHS Foundation Trust
Manchester, United Kingdom
Sensor Glucose readings within target range
Time spent in the target range of 3.9 to 10mmol/l based on sensor glucose levels, throughout the duration of the study periods based on continuous glucose monitoring (CGM).
Time frame: 8 weeks
Sensor Glucose readings below target range
Time spent with glucose levels below 3.9 mmol/L based on sensor glucose levels, throughout the duration of the study periods based on continuous glucose monitoring (CGM).
Time frame: 8 weeks
Sensor Glucose readings above target range
Time spent with glucose levels above 10.0 mmol/L based on sensor glucose levels, throughout the duration of the study periods based on continuous glucose monitoring (CGM).
Time frame: 8 weeks
HbA1c at 8 weeks
HbA1c at 8 weeks (midway point)
Time frame: 8 weeks
Average variation of glucose levels
Average variation of glucose levels
Time frame: 8 weeks
Standard deviation variation of glucose levels
Standard deviation variation of glucose levels
Time frame: 8 weeks
Coefficient variation of glucose levels
Coefficient variation of glucose levels
Time frame: 8 weeks
The time with sensor glucose levels < 3.5 mmol/l , 3.0 and <2.8 mmol/l
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The time with sensor glucose levels \< 3.5 mmol/l , 3.0 and \<2.8 mmol/l
Time frame: 8 weeks
The time with sensor glucose levels in the significant hyperglycaemia (glucose levels > 16.7 mmol/l)
The time with glucose levels in the significant hyperglycaemia (glucose levels \> 16.7 mmol/l)
Time frame: 8 weeks
AUC of glucose below 3.5mmol/l
AUC (Area under the Curve) of glucose below 3.5mmol/l
Time frame: 8 weeks
Total daily insulin dose
Total, basal and bolus insulin dose
Time frame: 8 weeks