Bolus Calculator and Wireless Communication With Blood Glucose Meter in Management of Type 1 Diabetes Mellitus (T1DM).

• HbA1c (Glycated hemoglobin) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  

• Post- prandial glycaemia [ Time Frame: 2 hours after the meals ] [ Designated as safety issue: Yes ]
  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
  
  
• Treatment satisfaction [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  Simple questions regarded treatment satisfaction and wish to continuation.
  
  
• Hypoglycaemia episodes and severe hypoglycaemia events [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  Hypoglycaemia defined as glycaemia below 70 mg/dl and, separately, glycaemia below 50 mg/dl.
  
  
• Frequency of self- blood glucose monitoring [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  Number of self- blood glucose monitoring per day
  
  
• Hyperglycaemic episodes [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  Hyperglycaemia defined as glycaemia above 180 mg/dl
  
  
• Frequency of meal boluses [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  Number of meal boluses per day
  
  
• Frequency of bolus calculator using [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  Number of bolus calculator use per day
  
  

• Total daily dose of insulin [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  Total daily dose of insulin express as jm/kg/d
  
  
• Body mass index- standard deviation (BMI- sds) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  Body mass index- sds
  
  

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.