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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Type 1 Diabetes Mellitus

Intervention / Treatment
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* Device: CSII+BC+CL
* Device: CSII+BC


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CSII+BC+CL<br>Patients using insulin pump (CSII) bolus calculator (BC) wirelessly connected with blood glucose meter Contour Link (CL) | Device: CSII+BC+CL<br>* Insulin pump bolus calculator wirelessly communicated with blood glucose meter (Contour Link)<br>* Other names: Insulin pump, bolus calculator, bolus Wizard, Contour Link;|
| Experimental: CSII+BC<br>Patients using insulin pump (CSII) bolus calculator (BC) without wireless connection with blood glucose meter (CL) | Device: CSII+BC<br>* Insulin pump bolus calculator without wireless communication with blood glucose meter (Contour Link)<br>* Other names: Insulin pump, bolus calculator, bolus Wizard;|
| No Intervention: CSII (insulin pump only)<br>Patients using insulin pump (CSII) without BC and connection with CL | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c (Glycated hemoglobin) |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post- prandial glycaemia | 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 hours after the meals | 
| Treatment satisfaction | Simple questions regarded treatment satisfaction and wish to continuation. | 3 months | 
| Hypoglycaemia episodes and severe hypoglycaemia events | Hypoglycaemia defined as glycaemia below 70 mg/dl and, separately, glycaemia below 50 mg/dl. | 3 months | 
| Frequency of self- blood glucose monitoring | Number of self- blood glucose monitoring per day | 3 months | 
| Hyperglycaemic episodes | Hyperglycaemia defined as glycaemia above 180 mg/dl | 3 months | 
| Frequency of meal boluses | Number of meal boluses per day | 3 months | 
| Frequency of bolus calculator using | Number of bolus calculator use per day | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes, insulin pump, bolus calculator, Contour Link