The primary objective of this study is to evaluate whether the patients with Type 1 diabetes mellitus in sub-optimal glycemic control can achieve better glycemic control by using the Medtronic MiniMed Paradigm® REAL-Time Pump System with continuous glucose monitoring versus the Medtronic MiniMed Paradigm® REAL-Time Pump alone with Self Monitoring Blood Glucose (SMBG).Our null hypothesis is there is a 0% reduction in HbA1c from baseline compared to control group, after 6 months of treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
153
6 months of pump plus continuous glucose sensing in conjunction to SMBG
insulin pump with smbg to be worn for 6 months. 15 days in each 6 week period blinded continuous glucose sensing will be conducted.
Hospital Hietzing
Vienna, Austria
Steno Diabetes Center
Copenhagen, Denmark
Glostrup Hospital
Glostrup Municipality, Denmark
Clinica Pediatrica, Policlinico Umberto I
Rome, Italy
HbA1c at 6 Month
The end of period difference in HbA1c after 6 months of treatment
Time frame: 6 months
Glycemic Variability
24 h SD of glucose values (mg/dl)
Time frame: 6 months
Number of Severe Hypoglycemia Events
Time frame: 6 months
Daily Min Spent in Euglycaemia (3.9-10.0 mmol/l)
Time frame: 6 months
Postprandial Glycaemia
Breakfast Postprandial glycaemia
Time frame: 6 months
Pediatric Quality of Life Inventory (Vers 4.0; PedsQL)
This questionnaire is a validated assessment of health-related quality of life in children developed by J.W. Varni, (1998). Scores are transformed on a scale from 0 to 100. higher values represent a better outcome
Time frame: 6 months
Diabetic Ketoacidosis Events
A diabetic ketoacidosis event (DKE) is defined as a hyperglycemia (blood glucose \>250 mg/dL) with either low serum bicarbonate (\<15 mEq/L) and/or low pH (\<7.3) and either ketonemia or ketonuria and requiring treatment within a health-care facility.
Time frame: 6 months
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Center Hospitalier de Luxembourg
Luxembourg, Luxembourg
Groene Hart Ziekenhuis
Gouda, Netherlands
University Children's Hospital
Ljubljana, Slovenia
Hospital Clinic i Universitari
Barcelona, Spain