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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03103867
• Date of registration: 26/03/2017
• Prospective Registration: No
• Primary sponsor: Centre Hospitalier du Luxembourg
• Public title: QUality of Control and slEep in Children With diabeteS, Using New Technology QUEST
• Scientific title: Evaluation of Two Different Glucose Monitoring Treatments and Their Impact on Time in Target, Sleep and Quality of Life in Children With Type 1 Diabetes and Primary Caregivers.
• Date of first enrolment: February 23, 2017
• Target sample size: 32
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03103867
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Luxembourg

Contacts

• Name: Carine de Beaufort, MD,PhD
• Affiliation: Centre Hospitalier du Luxembourg

Key inclusion & exclusion criteria

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 -



Age minimum: 6 Years
Age maximum: 14 Years
Gender: All

Health Condition(s) or Problem(s) studied

Diabetes Mellitus, Type 1

Intervention(s)

Device: CGM augmented pump with PLGS ,

Device: Insulin pump with CGM

Primary Outcome(s)

Time in glucose target [Time Frame: Last 6 days of treatment arm A and last 6 days of treatment arm B]

Secondary Outcome(s)

time below glucose target [Time Frame: Last 6 days of treatment arm A and last 6 days of treatment arm B]

Sleep quantity in patients and caregivers [Time Frame: baselines ( before treatment arm starts) and last week of treatment arm A and last week of treatment arm B]

hypoglycaemia fear in patients and caregivers [Time Frame: baseline 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 [Time Frame: baseline and last week of treatment arm A and last week of treatment arm B]

Time above glucose target [Time Frame: Last 6 days of treatment arm A and last 6 days of treatment arm B]

Secondary ID(s)

QUEST

Source(s) of Monetary Support

Please refer to primary and secondary sponsors