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

Medical University of Warsaw

Status: Completed

Conditions: Type 1 Diabetes Mellitus

Treatments: Device: CSII+BC; Device: CSII+BC+CL

Study type: Interventional

Funder types: Other

Identifiers

NCT01677546

Bolus-calculator

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 156 patients

Sex: All

Ages: 7 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 7- 18 years old
• type 1 diabetes mellitus for over 1 year
• treatment with insulin pump with bolus calculator function
• HbA1c < 10%
• expressed written informed consent

Exclusion criteria

• recall the consent

Trial design

156 participants in 3 patient groups

CSII+BC+CL

Experimental group

Description:

Patients using insulin pump (CSII) bolus calculator (BC) wirelessly connected with blood glucose meter Contour Link (CL)

Treatment:

Device: CSII+BC+CL

CSII+BC

Experimental group

Description:

Patients using insulin pump (CSII) bolus calculator (BC) without wireless connection with blood glucose meter (CL)

Treatment:

Device: CSII+BC

CSII (insulin pump only)

No Intervention group

Description:

Patients using insulin pump (CSII) without BC and connection with CL