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Trial record 10 of 113 for:    Luxembourg

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

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ClinicalTrials.gov Identifier: NCT03103867
Recruitment Status : Completed
First Posted : April 6, 2017
Last Update Posted : August 3, 2018
Sponsor:
Information provided by (Responsible Party):
Carine de Beaufort, 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Device: CGM augmented pump with PLGS , Device: Insulin pump with CGM Not Applicable

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  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Actual Study Start Date : February 23, 2017
Actual Primary Completion Date : May 4, 2018
Actual Study Completion Date : July 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

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 Name: 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 Name: 640G , freestyle libre




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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

  4. 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

  5. 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



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Ages Eligible for Study:   6 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03103867


Locations
Luxembourg
Clinique des Enfants CHluxembourg
Luxembourg, Luxembourg, 1210
Sponsors and Collaborators
Centre Hospitalier du Luxembourg
Investigators
Study Chair: Carine de Beaufort, MD,PhD Centre Hospitalier du Luxembourg

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Carine de Beaufort, Guest Professor , MD, PhD, Centre Hospitalier du Luxembourg
ClinicalTrials.gov Identifier: NCT03103867     History of Changes
Other Study ID Numbers: QUEST
First Posted: April 6, 2017    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs