Paediatric Use of the Abbott Sensor Based Glucose Monitoring System (PUGS)

Abbott logo

Abbott

Status

Completed

Conditions

Diabetes Mellitus

Treatments

Device: Abbott Sensor Based Glucose Monitoring System

Study type

Interventional

Funder types

Industry

Identifiers

NCT03433573
ADC-UK-VAL-17032

Details and patient eligibility

About

Accuracy evaluation of the Abbott Sensor Based Glucose Monitoring System when used by children with diabetes.

Enrollment

103 patients

Sex

All

Ages

4 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

* Age 4-17 years (inclusive). * Have type 1 or type 2 diabetes using insulin administered by injections or continuous subcutaneous insulin infusion (CSII). * Currently testing blood glucose levels at least twice per day. * Each participant has an identified Caregiver aged ≥18 years. * In the investigator's opinion, technically capable of using device (participant and/or caregiver).

Exclusion criteria

* Concomitant disease or condition that may compromise patient safety including and not limited to; cystic fibrosis, severe mental illness, known or suspected eating disorder or any uncontrolled long term medical condition. * Currently prescribed oral steroid therapy for any acute or chronic condition. * Currently receiving dialysis treatment or planning to receive dialysis during the study. * Female participant known to be pregnant. * Participating in another study of a glucose monitoring device or drug that could affect glucose measurements or management. * Currently using a real-time or professional use continuous glucose monitoring (CGM) or FreeStyle Libre device or is planning to use one during the study, and unwilling to stop use of the device during the study. * Known (or suspected) allergy to medical grade adhesives. * In the investigator's opinion the participant or caregiver is unsuitable to participate due to any other cause/reason (both patient and caregiver considered).

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

103 participants in 1 patient group

Intervention
Experimental group
Description:
Abbott Sensor Based Glucose Monitoring System
Treatment:
Device: Abbott Sensor Based Glucose Monitoring System

Trial contacts and locations

11

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Data sourced from clinicaltrials.gov

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