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

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Device: CGM augmented pump with PLGS ,; Device: Insulin pump with CGM

• Registration Number: NCT03103867
• Lead Sponsor: Centre Hospitalier du Luxembourg

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.

Study Timeline

• Study Start: 2017-02-23
• Study First Submitted: 2017-03-26
• Study First Submitted QC: 2017-03-31
• Study First Posted: 2017-04-06
• Primary Completion: 2018-05-04
• Study Completion: 2018-07-15
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-01
• Last Update Posted: 2018-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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 -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CGM augmented pump with PLGS (A)	CGM augmented pump with PLGS ,	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
Insulin pump with CGM (B)	Insulin pump with CGM	Administration of Subcutaneous administration of Continuous subcutaneous insulin infusion with second device measuring continuous glucose Randomised cross over treatment during 5 weeks

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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)
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

Trial Locations

Locations (1)

Clinique des Enfants CHluxembourg; 🇱🇺 Luxembourg, Luxembourg