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

Diabetes Mellitus, Type 1 Clinical Trial

— QUEST  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03103867
• Other study ID #: QUEST
• Status: Completed
• Phase: N/A
• Start date: February 23, 2017
• Est. completion date: July 15, 2018

Study information

• Verified date: August 2018
• Source: Centre Hospitalier du Luxembourg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: July 15, 2018
• Est. primary completion date: May 4, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 14 Years

Eligibility

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 -

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Device:
• CGM augmented pump with PLGS ,
5 weeks treatment CGM augmented pump with PLGS compared with 5 weeks treatment with insulin pump with CGM , without integration
• Insulin pump with CGM
5 weeks treatment continuous subcutaneous insulin infusion pump with CGM without data integration,

Locations

Country	Name	City	State
Luxembourg	Clinique des Enfants CHluxembourg	Luxembourg

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier du Luxembourg

Country where clinical trial is conducted

Luxembourg, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time in glucose target	Percent time in glucose target (3.9 -8 mmol/l) , measured by blinded CGM	Last 6 days of treatment arm A and last 6 days of treatment arm B
Secondary	time below glucose target	Percent time spent below glucose target (<3.0mmol/l and < 2,5 mmol/l) measured by blinded CGM (I-Pro 2)	Last 6 days of treatment arm A and last 6 days of treatment arm B
Secondary	Time above glucose target	Percent time spent above glucose target (>10.0mmol/l ) measured by blinded CGM (I-Pro 2)	Last 6 days of treatment arm A and last 6 days of treatment arm B
Secondary	Sleep quantity in patients and caregivers	Total sleep and wake time , number of awakenings measured by wireless actigraph	baselines ( before treatment arm starts) and last week of treatment arm A and last week of treatment arm B
Secondary	perception of quality of sleep and quality of life in patients and caregivers	validated questionnaires	baseline and last week of treatment arm A and last week of treatment arm B
Secondary	hypoglycaemia fear in patients and caregivers	Hypoglycemia fear survey for parents and children	baseline and last week of treatment arm A and last week of treatment arm B