The purpose of this study is to determine whether Type 1 diabetic patients using the Guardian RT glucose sensor can improve glycemic control over a 12-week period, compared to patients using self-monitoring blood glucose testing (SMBG) alone.
The long-term benefit of tight glycemic control in diabetics is well documented. HbA1c generally assesses the average/long term quality of glycemic control. On a daily basis, patients assess their glycemic control through finger stick measurements (SMBG), which allows them to adjust their therapy. A device which would provide a patient with a real-time glucose value, as well as high and low alerts, could aid the patient in knowing when to perform confirmatory SMBG tests and intervene so that dangerous glycemic excursions may occur less frequently.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
156
Hospital Sud Francilien
Corbeil-Essonnes, France
CH Robert Debre
Paris, France
Klinik fur Allgemeine Charite
Berlin, Germany
Schneider Children Centre
Petah Tikva, Israel
Difference in Change in A1c (%) between continuous use of CGM and control
Time frame: 12 weeks
Difference in change in A1c (%) between biweekly use of CGM and control
Time frame: 12 weeks
Difference in change in A1c (%) between biweekly use of CGM and continuous use of CGM
Time frame: 12 weeks
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