Clinical trial NCT01677546: Bolus Calculator and Wireless Communication With Blood Glucose Meter in Management of Type 1 Diabetes Mellitus (T1DM).
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Keywords: diabetes
insulin pump
bolus calculator
Contour Link
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2012-09-03
Enrollment: 156
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

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 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

Primary outcomes:
measure: HbA1c (Glycated hemoglobin)
timeFrame: 3 months
Secondary outcomes:
measure: Post- prandial glycaemia
timeFrame: 2 hours after the meals
measure: Treatment satisfaction
timeFrame: 3 months
measure: Hypoglycaemia episodes and severe hypoglycaemia events
timeFrame: 3 months
measure: Frequency of self- blood glucose monitoring
timeFrame: 3 months
measure: Hyperglycaemic episodes
timeFrame: 3 months
measure: Frequency of meal boluses
timeFrame: 3 months
measure: Frequency of bolus calculator using
timeFrame: 3 months
Other outcomes:
measure: Total daily dose of insulin
timeFrame: 3 months
measure: Body mass index- standard deviation (BMI- sds)
timeFrame: 3 months
Locations:
city: Warsaw
country: Poland
facility: Medical University of Warsaw
Study officials:
affiliation: Medical University of Warsaw
name: Agnieszka Szypowska, A. Professor
role: STUDY_CHAIR
References:
citation: 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.