NCT01677546

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 3, 2012

Completed
Last Updated

September 3, 2012

Status Verified

August 1, 2012

Enrollment Period

1.5 years

First QC Date

August 22, 2012

Last Update Submit

August 29, 2012

Conditions

Type 1 Diabetes Mellitus

Keywords

diabetesinsulin pumpbolus calculatorContour Link

Outcome Measures

Primary Outcomes (1)

  • HbA1c (Glycated hemoglobin)

    3 months

Secondary Outcomes (7)

  • Post- prandial glycaemia

    2 hours after the meals

  • Treatment satisfaction

    3 months

  • Hypoglycaemia episodes and severe hypoglycaemia events

    3 months

  • Frequency of self- blood glucose monitoring

    3 months

  • Hyperglycaemic episodes

    3 months

  • +2 more secondary outcomes

Other Outcomes (2)

  • Total daily dose of insulin

    3 months

  • Body mass index- standard deviation (BMI- sds)

    3 months

Study Arms (3)

CSII+BC+CL

EXPERIMENTAL

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

Device: CSII+BC+CL

CSII+BC

EXPERIMENTAL

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

Device: CSII+BC

CSII (insulin pump only)

NO INTERVENTION

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

Interventions

CSII+BC+CLDEVICE

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

Also known as: Insulin pump, bolus calculator, bolus Wizard, Contour Link
CSII+BC+CL
CSII+BCDEVICE

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

Also known as: Insulin pump, bolus calculator, bolus Wizard
CSII+BC

Eligibility Criteria

Age7 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • recall the consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Warsaw

Warsaw, Poland

Location

Related Publications (1)

  • 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.

    PMID: 24115314DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Agnieszka Szypowska, A. Professor

    Medical University of Warsaw

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2012

First Posted

September 3, 2012

Study Start

January 1, 2011

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

September 3, 2012

Record last verified: 2012-08

Locations

PL(1)