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

Type 1 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01677546
• Other study ID #: Bolus-calculator
• Status: Completed
• Phase: N/A
• First received: August 22, 2012
• Last updated: August 29, 2012
• Start date: January 2011
• Est. completion date: July 2012

Study information

• Verified date: August 2012
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Device:
• CSII+BC+CL
Insulin pump bolus calculator wirelessly communicated with blood glucose meter (Contour Link)
• CSII+BC
Insulin pump bolus calculator without wireless communication with blood glucose meter (Contour Link)

Locations

Country	Name	City	State
Poland	Medical University of Warsaw	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Total daily dose of insulin	Total daily dose of insulin express as jm/kg/d	3 months	No
Other	Body mass index- standard deviation (BMI- sds)	Body mass index- sds	3 months	No
Primary	HbA1c (Glycated hemoglobin)		3 months	Yes
Secondary	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	Yes
Secondary	Treatment satisfaction	Simple questions regarded treatment satisfaction and wish to continuation.	3 months	No
Secondary	Hypoglycaemia episodes and severe hypoglycaemia events	Hypoglycaemia defined as glycaemia below 70 mg/dl and, separately, glycaemia below 50 mg/dl.	3 months	Yes
Secondary	Frequency of self- blood glucose monitoring	Number of self- blood glucose monitoring per day	3 months	No
Secondary	Hyperglycaemic episodes	Hyperglycaemia defined as glycaemia above 180 mg/dl	3 months	No
Secondary	Frequency of meal boluses	Number of meal boluses per day	3 months	No
Secondary	Frequency of bolus calculator using	Number of bolus calculator use per day	3 months	No