Diabetes Mellitus, Type 1
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICECGM augmented pump with PLGS ,
5 weeks treatment CGM augmented pump with PLGS compared with 5 weeks treatment with insulin pump with CGM , without integration
DEVICEInsulin pump with CGM
5 weeks treatment continuous subcutaneous insulin infusion pump with CGM without data integration,
Sponsors
Centre Hospitalier du Luxembourg
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 14 Years
Healthy volunteers
No
Inclusion criteria
* Type 1 diabetes * Duration of diabetes ≥ 6 months * Insulin pump treatment ≥ 6 months * HbA1c ≤ 11% * Parental written informed consent
Exclusion criteria
. No parental consent * Physical or psychological disease likely to interfere with an appropriate conduct of the study * Current drug therapy knowing to interfere with glucose metabolism * Chronic sleep medication in the primary caregiver or the patient -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time in glucose target | Last 6 days of treatment arm A and last 6 days of treatment arm B | Percent time in glucose target (3.9 -8 mmol/l) , measured by blinded CGM |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| time below glucose target | Last 6 days of treatment arm A and last 6 days of treatment arm B | Percent time spent below glucose target (\<3.0mmol/l and \< 2,5 mmol/l) measured by blinded CGM (I-Pro 2) |
| Time above glucose target | Last 6 days of treatment arm A and last 6 days of treatment arm B | Percent time spent above glucose target (\>10.0mmol/l ) measured by blinded CGM (I-Pro 2) |
| Sleep quantity in patients and caregivers | baselines ( before treatment arm starts) and last week of treatment arm A and last week of treatment arm B | Total sleep and wake time , number of awakenings measured by wireless actigraph |
| perception of quality of sleep and quality of life in patients and caregivers | baseline and last week of treatment arm A and last week of treatment arm B | validated questionnaires |
| hypoglycaemia fear in patients and caregivers | baseline and last week of treatment arm A and last week of treatment arm B | Hypoglycemia fear survey for parents and children |
Countries
Luxembourg
Outcome results
None listed