Clinical trial NCT03103867: QUality of Control and slEep in Children With diabeteS, Using New Technology
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: Centre Hospitalier du Luxembourg
Sponsor class: OTHER
First posted: 2017-04-06
Enrollment: 32
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility 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 -

Primary outcomes:
measure: Time in glucose target
timeFrame: Last 6 days of treatment arm A and last 6 days of treatment arm B
Secondary outcomes:
measure: time below glucose target
timeFrame: Last 6 days of treatment arm A and last 6 days of treatment arm B
measure: Time above glucose target
timeFrame: Last 6 days of treatment arm A and last 6 days of treatment arm B
measure: Sleep quantity in patients and caregivers
timeFrame: baselines ( before treatment arm starts) and last week of treatment arm A and last week of treatment arm B
measure: perception of quality of sleep and quality of life in patients and caregivers
timeFrame: baseline and last week of treatment arm A and last week of treatment arm B
measure: hypoglycaemia fear in patients and caregivers
timeFrame: baseline and last week of treatment arm A and last week of treatment arm B
Other outcomes:
Locations:
city: Luxembourg
country: Luxembourg
facility: Clinique des Enfants CHluxembourg
Study officials:
affiliation: Centre Hospitalier du Luxembourg
name: Carine de Beaufort, MD,PhD
role: STUDY_CHAIR
References:
citation: Schierloh U, Aguayo GA, Schritz A, Fichelle M, De Melo Dias C, Vaillant MT, Cohen O, Gies I, de Beaufort C. Intermittent Scanning Glucose Monitoring or Predicted Low Suspend Pump Treatment: Does It Impact Time in Glucose Target and Treatment Preference? The QUEST Randomized Crossover Study. Front Endocrinol (Lausanne). 2022 May 31;13:870916. doi: 10.3389/fendo.2022.870916. eCollection 2022.
citation: Schierloh U, Aguayo GA, Fichelle M, De Melo Dias C, Celebic A, Vaillant M, Barnard K, Cohen O, de Beaufort C. Effect of predicted low suspend pump treatment on improving glycaemic control and quality of sleep in children with type 1 diabetes and their caregivers: the QUEST randomized crossover study. Trials. 2018 Dec 4;19(1):665. doi: 10.1186/s13063-018-3034-4.