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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01677546

Enrollment

156

Registered

2012-09-03

Start date

2011-01-31

Completion date

2012-07-31

Last updated

2012-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes Mellitus

Keywords

diabetes, insulin pump, bolus calculator, Contour Link

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.

Interventions

DEVICECSII+BC+CL

Insulin pump bolus calculator wirelessly communicated with blood glucose meter (Contour Link)

DEVICECSII+BC

Insulin pump bolus calculator without wireless communication with blood glucose meter (Contour Link)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

7 Years to 18 Years

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

Design outcomes

Primary

Measure	Time frame
HbA1c (Glycated hemoglobin)	3 months

Secondary

Measure	Time frame	Description
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
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
Hyperglycaemic episodes	3 months	Hyperglycaemia defined as glycaemia above 180 mg/dl

Other

Measure	Time frame	Description
Total daily dose of insulin	3 months	Total daily dose of insulin express as jm/kg/d
Body mass index- standard deviation (BMI- sds)	3 months	Body mass index- sds

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026