Bolus Calculator and Wireless Communication With Blood Glucose Meter in Management of Type 1 Diabetes Mellitus (T1DM).
|ClinicalTrials.gov Identifier: NCT01677546|
Recruitment Status : Completed
First Posted : September 3, 2012
Last Update Posted : September 3, 2012
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Mellitus||Device: CSII+BC+CL Device: CSII+BC||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||156 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (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|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||July 2012|
Patients using insulin pump (CSII) bolus calculator (BC) wirelessly connected with blood glucose meter Contour Link (CL)
Insulin pump bolus calculator wirelessly communicated with blood glucose meter (Contour Link)
Other Name: Insulin pump, bolus calculator, bolus Wizard, Contour Link
Patients using insulin pump (CSII) bolus calculator (BC) without wireless connection with blood glucose meter (CL)
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
- HbA1c (Glycated hemoglobin) [ Time Frame: 3 months ]
- 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
- Treatment satisfaction [ Time Frame: 3 months ]Simple questions regarded treatment satisfaction and wish to continuation.
- 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.
- Frequency of self- blood glucose monitoring [ Time Frame: 3 months ]Number of self- blood glucose monitoring per day
- Hyperglycaemic episodes [ Time Frame: 3 months ]Hyperglycaemia defined as glycaemia above 180 mg/dl
- Frequency of meal boluses [ Time Frame: 3 months ]Number of meal boluses per day
- Frequency of bolus calculator using [ Time Frame: 3 months ]Number of bolus calculator use per day
- Total daily dose of insulin [ Time Frame: 3 months ]Total daily dose of insulin express as jm/kg/d
- Body mass index- standard deviation (BMI- sds) [ Time Frame: 3 months ]Body mass index- sds
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01677546
|Medical University of Warsaw|
|Study Chair:||Agnieszka Szypowska, A. Professor||Medical University of Warsaw|