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Completed

NCT Number: NCT01677546

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

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.

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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

7 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Warsaw

Warsaw, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CSII+BC+CL

Device

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

Other names: Insulin pump, bolus calculator, bolus Wizard, Contour Link

CSII+BC

Device

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

Other names: Insulin pump, bolus calculator, bolus Wizard

Primary outcomes

  1. HbA1c (Glycated hemoglobin)

    Time frame: 3 months

Secondary outcomes

  1. 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. Treatment satisfaction

    Time frame: 3 months

    Simple questions regarded treatment satisfaction and wish to continuation.

  3. 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.

  4. Frequency of self- blood glucose monitoring

    Time frame: 3 months

    Number of self- blood glucose monitoring per day

  5. Hyperglycaemic episodes

    Time frame: 3 months

    Hyperglycaemia defined as glycaemia above 180 mg/dl

  6. Frequency of meal boluses

    Time frame: 3 months

    Number of meal boluses per day

  7. Frequency of bolus calculator using

    Time frame: 3 months

    Number of bolus calculator use per day

Other outcomes

  1. Total daily dose of insulin

    Time frame: 3 months

    Total daily dose of insulin express as jm/kg/d

  2. Body mass index- standard deviation (BMI- sds)

    Time frame: 3 months

    Body mass index- sds

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Sep 3, 2012
Registry last updated
Sep 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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