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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-07-31

Brief Summary

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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

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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.

Conditions

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Type 1 Diabetes Mellitus

Keywords

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diabetes insulin pump bolus calculator Contour Link

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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CSII+BC+CL

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

Group Type EXPERIMENTAL

CSII+BC+CL

Intervention Type DEVICE

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

CSII+BC

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

Group Type EXPERIMENTAL

CSII+BC

Intervention Type DEVICE

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

CSII (insulin pump only)

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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CSII+BC+CL

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

Intervention Type DEVICE

CSII+BC

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

Intervention Type DEVICE

Other Intervention Names

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Insulin pump, bolus calculator, bolus Wizard, Contour Link Insulin pump, bolus calculator, bolus Wizard

Eligibility Criteria

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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

Minimum Eligible Age

7 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Agnieszka Szypowska, A. Professor

Role: STUDY_CHAIR

Medical University of Warsaw

Locations

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Medical University of Warsaw

Warsaw, , Poland

Site Status

Countries

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Poland

References

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Ramotowska A, Szypowska A. Bolus calculator and wirelessly communicated blood glucose measurement effectively reduce hypoglycaemia in type 1 diabetic children - randomized controlled trial. Diabetes Metab Res Rev. 2014 Feb;30(2):146-53. doi: 10.1002/dmrr.2477.

Reference Type DERIVED

PMID: 24115314 (View on PubMed)

Other Identifiers

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