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.

Abstract

Background: The aim of this study was to assess the effect of bolus calculator function and wireless communication between insulin pump and blood glucose metre on metabolic control in children with type 1 diabetes, treated with insulin pumps.

Methods: In this randomized, controlled, 12-week trial, 156 patients, aged 12.9 ± 2.6 years, with a history of diabetes of 5.1 ± 3.3 years and glycated haemoglobin values of 7.3 ± 1.2% (56.3 ± 13.44 mmol/mol) were included. Children were assigned to one of three arms: group A, subjects using bolus calculator and wireless communication between insulin pump and blood glucose metre; group B, subjects using bolus calculator without communication between the devices and group C, control group. Devices were downloaded at 0, 6 and 12 weeks.

Results: There were statistically fewer episodes of hypoglycaemia in children using bolus calculator compared with the control group: A versus C (3.8 ± 3.1 versus 7.8 ± 5.13 episodes/2 weeks, respectively, p < 0.0001); B versus C (3.6 ± 3.3 versus 7.8 ± 5.1 episodes/2 weeks, respectively, p < 0.0001). Patients in group A used bolus calculator function significantly more frequently than patients in group B (4.9 ± 3.4 versus 2.5 ± 2.9 times/24 h, respectively, p = 0.0006). No significant differences in glycated haemoglobin levels were found between the experimental and the control groups: group A versus C (p = 0.699). The use of bolus calculator did not influence post-prandial glycaemia, body mass index-SD score or insulin/kg/24 h.

Conclusions: Bolus calculator use reduces hypoglycaemic episodes independently of communication between insulin pump and blood glucose metre. Wireless communication between devices results in more frequent bolus calculator use.

Trial registration: ClinicalTrials.gov NCT01677546.

Keywords: bolus wizard; insulin pump; prandial insulin; wireless communication.

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adolescent Behavior
  • Blood Glucose / analysis
  • Blood Glucose Self-Monitoring* / instrumentation
  • Child
  • Child Behavior
  • Diabetes Mellitus, Type 1 / blood
  • Diabetes Mellitus, Type 1 / drug therapy*
  • Drug Dosage Calculations
  • Follow-Up Studies
  • Glycated Hemoglobin / analysis
  • Humans
  • Hyperglycemia / epidemiology
  • Hyperglycemia / prevention & control
  • Hypoglycemia / epidemiology
  • Hypoglycemia / prevention & control*
  • Hypoglycemic Agents / administration & dosage*
  • Hypoglycemic Agents / adverse effects
  • Hypoglycemic Agents / therapeutic use
  • Incidence
  • Insulin Infusion Systems*
  • Insulin, Short-Acting / administration & dosage*
  • Insulin, Short-Acting / adverse effects
  • Insulin, Short-Acting / therapeutic use
  • Lost to Follow-Up
  • Patient Compliance
  • Poland / epidemiology
  • Postprandial Period
  • Wireless Technology*

Substances

  • Blood Glucose
  • Glycated Hemoglobin A
  • Hypoglycemic Agents
  • Insulin, Short-Acting
  • hemoglobin A1c protein, human

Associated data

  • ClinicalTrials.gov/NCT01677546