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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-23

Study Completion Date

2018-07-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparison of Two Management Systems in Patients With Type 1 Diabetes (Pediatric SmartHome)

NCT03815487

Patient Care Drug Therapy

COMPLETED NA

Prevention of Hypoglycaemia With Predictive Insulin Suspend Using Sensor Augmented Insulin Pump in Children

NCT02179281

Type 1 Diabetes Mellitus

COMPLETED NA

Dual-wave Boluses in Children With Type 1 Diabetes Insulin Boluses in Children With Type 1 Diabetes

NCT04668612

Type 1 Diabetes

UNKNOWN NA

Real-Time Continuous Glucose Monitoring in Pre-School Children With Type-1 Diabetes Mellitus

NCT01016457

Diabetes Mellitus

UNKNOWN PHASE4

Impact of the Continuous Measurement of Blood Glucose on Insulin Pump on Child Quality of Life With Type 1 Diabetes

NCT03177096

Type1diabetes

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus, Type 1

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

CGM augmented pump with PLGS ,

Intervention Type DEVICE

5 weeks treatment CGM augmented pump with PLGS compared with 5 weeks treatment with insulin pump with CGM , without integration

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

Group Type ACTIVE_COMPARATOR

Insulin pump with CGM

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DEVICE

Insulin pump with CGM

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

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

640G, Enlite Sensors , Freestyle Libre 640G , freestyle libre

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 -

Minimum Eligible Age

6 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No