Type 1 Diabetes Mellitus Clinical Trial
Official title:
The Impact of Insulin Pump Bolus Calculator and Wireless Communication With Blood Glucose Meter on Metabolic Control in Children With Type 1 Diabetes Mellitus - Randomised Control Trial
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
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