Bolus calculator (BC) is one of the advanced functions in modern insulin pumps (CSII)models. Together with wireless communication with blood glucose meter potentially facilitates achieving the target post prandial glucose levels. In this RCT authors assessed whether use of wireless communication between compatible devices: MiniMed insulin pump and blood glucose meter Contour Link (CL), Bayer results in more frequently bolus calculator using and what is the impact of exerting this tool on metabolic control in type 1 diabetic patients.
In this RCT 156 patients were randomly assigned to one of the 3 arms: group A- subjects using insulin pump bolus calculator wirelessly connected with blood glucose meter, group B- subjects using insulin pump bolus calculator without wireless communication with blood glucose meter or group C- insulin pump, without bolus calculator function. We compared the glycated hemoglobin levels and post- prandial hypoglycaemia after 3 months of observation between the groups. We also assessed secondary endpoints (mentioned above). Patients were estimated at three time points: at the beginning, after 6 weeks and after 3 months of intervention. Investigators performed computer reports at each visit, with Medtronic CareLink Pro software.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
156
Insulin pump bolus calculator wirelessly communicated with blood glucose meter (Contour Link)
Insulin pump bolus calculator without wireless communication with blood glucose meter (Contour Link)
Medical University of Warsaw
Warsaw, Poland
HbA1c (Glycated hemoglobin)
Time frame: 3 months
Post- prandial glycaemia
Post- prandial glycaemia is express as a mean post- prandial glycaemia counted after the meal consumed between 1- 6 pm during subsequently 7- 10 days
Time frame: 2 hours after the meals
Treatment satisfaction
Simple questions regarded treatment satisfaction and wish to continuation.
Time frame: 3 months
Hypoglycaemia episodes and severe hypoglycaemia events
Hypoglycaemia defined as glycaemia below 70 mg/dl and, separately, glycaemia below 50 mg/dl.
Time frame: 3 months
Frequency of self- blood glucose monitoring
Number of self- blood glucose monitoring per day
Time frame: 3 months
Hyperglycaemic episodes
Hyperglycaemia defined as glycaemia above 180 mg/dl
Time frame: 3 months
Frequency of meal boluses
Number of meal boluses per day
Time frame: 3 months
Frequency of bolus calculator using
Number of bolus calculator use per day
Time frame: 3 months
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