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

August 29, 2012 updated by: Medical University of Warsaw

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

156

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Warsaw, Poland
        • Medical University of Warsaw

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: CSII+BC+CL
Patients using insulin pump (CSII) bolus calculator (BC) wirelessly connected with blood glucose meter Contour Link (CL)
Device: CSII+BC+CL
Insulin pump bolus calculator wirelessly communicated with blood glucose meter (Contour Link)
Other Names:
  • Insulin pump, bolus calculator, bolus Wizard, Contour Link
EXPERIMENTAL: CSII+BC
Patients using insulin pump (CSII) bolus calculator (BC) without wireless connection with blood glucose meter (CL)
Device: CSII+BC
Insulin pump bolus calculator without wireless communication with blood glucose meter (Contour Link)
Other Names:
  • Insulin pump, bolus calculator, bolus Wizard
NO_INTERVENTION: CSII (insulin pump only)
Patients using insulin pump (CSII) without BC and connection with CL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HbA1c (Glycated hemoglobin)
Time Frame: 3 months
3 months

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Warsaw

Investigators

  • Study Chair: Agnieszka Szypowska, A. Professor, Medical University of Warsaw

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (ACTUAL)

July 1, 2012

Study Completion (ACTUAL)

July 1, 2012

Study Registration Dates

First Submitted

August 22, 2012

First Submitted That Met QC Criteria

August 29, 2012

First Posted (ESTIMATE)

September 3, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

September 3, 2012

Last Update Submitted That Met QC Criteria

August 29, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Bolus-calculator

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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