QUality of Control and slEep in Children With diabeteS, Using New Technology (QUEST)

Centre Hospitalier du Luxembourg

Status: Completed

Conditions: Diabetes Mellitus, Type 1

Treatments: Device: CGM augmented pump with PLGS ,; Device: Insulin pump with CGM

Study type: Interventional

Funder types: Other

Identifiers

NCT03103867

QUEST

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 6 to 14 years old

Volunteers: No Healthy Volunteers

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 -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

32 participants in 2 patient groups

CGM augmented pump with PLGS (A)

Experimental group

Description:

Administration of Subcutaneous administration of Continuous subcutaneous insulin infusion with integrated continuous glucose monitoring and predicted low glucose suspense (PLGS) Randomised cross over treatment during 5 weeks

Treatment:

Device: CGM augmented pump with PLGS ,

Insulin pump with CGM (B)

Active Comparator group

Description:

Administration of Subcutaneous administration of Continuous subcutaneous insulin infusion with second device measuring continuous glucose Randomised cross over treatment during 5 weeks

Treatment:

Device: Insulin pump with CGM