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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medical University of Warsaw
ClinicalTrials.gov Identifier:
NCT01677546
First received: August 22, 2012
Last updated: August 29, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention
Type 1 Diabetes Mellitus
Device: CSII+BC+CL
Device: CSII+BC

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official 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

Resource links provided by NLM:


Further study details as provided by Medical University of Warsaw:

Primary Outcome Measures:
  • HbA1c (Glycated hemoglobin) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Post- prandial glycaemia [ Time Frame: 2 hours after the meals ] [ Designated as safety issue: Yes ]
    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

  • Treatment satisfaction [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Simple questions regarded treatment satisfaction and wish to continuation.

  • Hypoglycaemia episodes and severe hypoglycaemia events [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Hypoglycaemia defined as glycaemia below 70 mg/dl and, separately, glycaemia below 50 mg/dl.

  • Frequency of self- blood glucose monitoring [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Number of self- blood glucose monitoring per day

  • Hyperglycaemic episodes [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Hyperglycaemia defined as glycaemia above 180 mg/dl

  • Frequency of meal boluses [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Number of meal boluses per day

  • Frequency of bolus calculator using [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Number of bolus calculator use per day


Other Outcome Measures:
  • Total daily dose of insulin [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Total daily dose of insulin express as jm/kg/d

  • Body mass index- standard deviation (BMI- sds) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Body mass index- sds


Enrollment: 156
Study Start Date: January 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Insulin pump, bolus calculator, bolus Wizard
No Intervention: CSII (insulin pump only)
Patients using insulin pump (CSII) without BC and connection with CL

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.

  Eligibility

Ages Eligible for Study:   7 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01677546

Locations
Poland
Medical University of Warsaw
Warsaw, Poland
Sponsors and Collaborators
Medical University of Warsaw
Investigators
Study Chair: Agnieszka Szypowska, A. Professor Medical University of Warsaw
  More Information

No publications provided

Responsible Party: Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT01677546     History of Changes
Other Study ID Numbers: Bolus-calculator
Study First Received: August 22, 2012
Last Updated: August 29, 2012
Health Authority: Poland: Ethics Committee

Keywords provided by Medical University of Warsaw:
diabetes
insulin pump
bolus calculator
Contour Link

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014