The study is an open label single centre randomised cross over study to evaluate the impact of a sensor augmented pump (SAP) with a predictive algorithm to suspend temporarily insulin administration (640G® with the Smart Guard feature) versus the use of the same pump for insulin administration with 'only' continuous glucose measurements (not interacting with the pump, Freestyle Libre ® ) on the time in glucose target , in hypo- and hyperglycemia. Exploratory endpoints are the effect on sleep and quality of life in children with type 1 diabetes and their caregivers.
Optimising metabolic control in children with Type 1Diabetes Mellitus (T1DM) is essential to prevent late complications. Fear of nocturnal hypoglycemia is pervasive amongst parents of children with T1DM, leading to a heightened vigilance by parents to control regularly their children's blood sugar values or to check the sensor information during the night. This leads to chronic sleep interruption and to lack of sleep as well in the parents as in their children with diabetes. In this study, the impact of new technologies on glucose time in target , hypo fear and quality of life will be evaluated, using continuous interstitial glucose measurements either with a direct impact on insulin administration (640G medtronic pump (R)) and with alerts , or without impact on insulin administration and without alerts.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
5 weeks treatment CGM augmented pump with PLGS compared with 5 weeks treatment with insulin pump with CGM , without integration
5 weeks treatment continuous subcutaneous insulin infusion pump with CGM without data integration,
Clinique des Enfants CHluxembourg
Luxembourg, Luxembourg
Time in glucose target
Percent time in glucose target (3.9 -8 mmol/l) , measured by blinded CGM
Time frame: Last 6 days of treatment arm A and last 6 days of treatment arm B
time below glucose target
Percent time spent below glucose target (\<3.0mmol/l and \< 2,5 mmol/l) measured by blinded CGM (I-Pro 2)
Time frame: Last 6 days of treatment arm A and last 6 days of treatment arm B
Time above glucose target
Percent time spent above glucose target (\>10.0mmol/l ) measured by blinded CGM (I-Pro 2)
Time frame: Last 6 days of treatment arm A and last 6 days of treatment arm B
Sleep quantity in patients and caregivers
Total sleep and wake time , number of awakenings measured by wireless actigraph
Time frame: baselines ( before treatment arm starts) and last week of treatment arm A and last week of treatment arm B
perception of quality of sleep and quality of life in patients and caregivers
validated questionnaires
Time frame: baseline and last week of treatment arm A and last week of treatment arm B
hypoglycaemia fear in patients and caregivers
Hypoglycemia fear survey for parents and children
Time frame: baseline and last week of treatment arm A and last week of treatment arm B
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