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

August 1, 2018 updated by: Carine de Beaufort, Centre Hospitalier du Luxembourg

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Luxembourg
      • Luxembourg, Luxembourg, 1210
        • Clinique des Enfants CHluxembourg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CGM augmented pump with PLGS (A)
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
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
Other Names:
  • 640G, Enlite Sensors , Freestyle Libre
Active Comparator: Insulin pump with CGM (B)
Administration of Subcutaneous administration of Continuous subcutaneous insulin infusion with second device measuring continuous glucose Randomised cross over treatment during 5 weeks
Device: Insulin pump with CGM
5 weeks treatment continuous subcutaneous insulin infusion pump with CGM without data integration,
Other Names:
  • 640G , freestyle libre

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time in glucose target
Time Frame: 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
Last 6 days of treatment arm A and last 6 days of treatment arm B

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time below glucose target
Time Frame: 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)
Last 6 days of treatment arm A and last 6 days 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
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
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
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
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
validated questionnaires
baseline 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
Hypoglycemia fear survey for parents and children
baseline and last week of treatment arm A and last week of treatment arm B

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier du Luxembourg

Investigators

  • Study Chair: Carine de Beaufort, MD,PhD, Centre Hospitalier du Luxembourg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 23, 2017

Primary Completion (Actual)

May 4, 2018

Study Completion (Actual)

July 15, 2018

Study Registration Dates

First Submitted

March 26, 2017

First Submitted That Met QC Criteria

March 31, 2017

First Posted (Actual)

April 6, 2017

Study Record Updates

Last Update Posted (Actual)

August 3, 2018

Last Update Submitted That Met QC Criteria

August 1, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QUEST

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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