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

NCT03103867 | Completed FDA Device

• 1 other identifier: QUEST
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• time below glucose target

  Last 6 days of treatment arm A and last 6 days of treatment arm B

• Time above glucose target

  Last 6 days of treatment arm A and last 6 days of treatment arm B

• 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

• 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

• hypoglycaemia fear in patients and caregivers

  baseline and last week of treatment arm A and last week of treatment arm B

Study Arms (2)

CGM augmented pump with PLGS (A)

EXPERIMENTAL

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 ,

Insulin pump with CGM (B)

ACTIVE COMPARATOR

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

Interventions

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

Also known as: 640G, Enlite Sensors , Freestyle Libre

CGM augmented pump with PLGS (A)

Insulin pump with CGM DEVICE

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

Also known as: 640G , freestyle libre

Insulin pump with CGM (B)

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Type 1 diabetes
• Duration of diabetes ≥ 6 months
• Insulin pump treatment ≥ 6 months
• HbA1c ≤ 11%
• Parental written informed consent

You may not qualify if:

• 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 -

Sponsors & Collaborators

• Centre Hospitalier du Luxembourg: lead

Study Sites (1)

Clinique des Enfants CHluxembourg

Luxembourg, 1210, Luxembourg

Location

Related Publications (3)

• Schierloh U, Aguayo GA, Fichelle M, De Melo Dias C, Schritz A, Vaillant M, Barnard-Kelly K, Cohen O, Gies I, de Beaufort C. Fear of hypoglycemia and sleep in children with type 1 diabetes and their parents. Front Endocrinol (Lausanne). 2024 Dec 16;15:1419502. doi: 10.3389/fendo.2024.1419502. eCollection 2024.

  PMID: 39736868 DERIVED

• Schierloh U, Aguayo GA, Schritz A, Fichelle M, De Melo Dias C, Vaillant MT, Cohen O, Gies I, de Beaufort C. Intermittent Scanning Glucose Monitoring or Predicted Low Suspend Pump Treatment: Does It Impact Time in Glucose Target and Treatment Preference? The QUEST Randomized Crossover Study. Front Endocrinol (Lausanne). 2022 May 31;13:870916. doi: 10.3389/fendo.2022.870916. eCollection 2022.

  PMID: 35712259 DERIVED

• Schierloh U, Aguayo GA, Fichelle M, De Melo Dias C, Celebic A, Vaillant M, Barnard K, Cohen O, de Beaufort C. Effect of predicted low suspend pump treatment on improving glycaemic control and quality of sleep in children with type 1 diabetes and their caregivers: the QUEST randomized crossover study. Trials. 2018 Dec 4;19(1):665. doi: 10.1186/s13063-018-3034-4.

  PMID: 30509293 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Officials

• Carine de Beaufort, MD,PhD

  Centre Hospitalier du Luxembourg

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Guest Professor , MD, PhD

Study Record Dates

• First Submitted: March 26, 2017
• First Posted: April 6, 2017
• Study Start: February 23, 2017
• Primary Completion: May 4, 2018
• Study Completion: July 15, 2018
• Last Updated: August 3, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

LU (1)