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OpenTrials
Completed

NCT Number: NCT03103867

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

6 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique des Enfants CHluxembourg

Luxembourg, 1210

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 -

Treatment and study plan

CGM augmented pump with PLGS ,

Device

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

Insulin pump with CGM

Device

5 weeks treatment continuous subcutaneous insulin infusion pump with CGM without data integration,

Other names: 640G , freestyle libre

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier du Luxembourg

Other

Registry information

Official study 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.

Acronym: QUEST

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 6, 2017
Registry last updated
Aug 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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