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

Not Applicable

Completed

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Device: CSII+BC+CL; Device: CSII+BC

• Registration Number: NCT01677546
• Lead Sponsor: Medical University of Warsaw

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2012-08
• Study First Submitted: 2012-08-22
• Study First Submitted QC: 2012-08-29
• Last Update Submitted: 2012-08-29
• Study First Posted: 2012-09-03
• Last Update Posted: 2012-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 156

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CSII+BC+CL	CSII+BC+CL	Patients using insulin pump (CSII) bolus calculator (BC) wirelessly connected with blood glucose meter Contour Link (CL)
CSII+BC	CSII+BC	Patients using insulin pump (CSII) bolus calculator (BC) without wireless connection with blood glucose meter (CL)

Primary Outcome Measures

Name	Time	Method
HbA1c (Glycated hemoglobin)	3 months

Secondary Outcome Measures

Name	Time	Method
Post- prandial glycaemia	2 hours after the meals	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	3 months	Simple questions regarded treatment satisfaction and wish to continuation.
Hypoglycaemia episodes and severe hypoglycaemia events	3 months	Hypoglycaemia defined as glycaemia below 70 mg/dl and, separately, glycaemia below 50 mg/dl.
Frequency of self- blood glucose monitoring	3 months	Number of self- blood glucose monitoring per day
Hyperglycaemic episodes	3 months	Hyperglycaemia defined as glycaemia above 180 mg/dl
Frequency of meal boluses	3 months	Number of meal boluses per day
Frequency of bolus calculator using	3 months	Number of bolus calculator use per day

Trial Locations

Locations (1)

Medical University of Warsaw; 🇵🇱 Warsaw, Poland