Safety and efficacy of the predictive low glucose management system in the prevention of hypoglycaemia: protocol for randomised controlled home trial to evaluate the Suspend before low function

IntroductionInnovations with sensor-augmented pump therapy (SAPT) to reduce hypoglycaemia in patients with type 1 diabetes are an ongoing area of research. The predictive low glucose management (PLGM) system incorporates continuous glucose sensor data into an algorithm and suspends basal insulin bef...

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Bibliographic Details
Published in:BMJ open 2016-04, Vol.6 (4), p.e011589
Main Authors: Abraham, M B, Nicholas, J A, Ly, T T, Roby, H C, Paramalingam, N, Fairchild, J, King, B R, Ambler, G R, Cameron, F, Davis, E A, Jones, T W
Format: Article
Language:English
Subjects:
Adolescent
Adult
Blood Glucose - metabolism
Caregivers
Child
Children & youth
Consent
Control algorithms
Diabetes
Diabetes and Endocrinology
Diabetes Mellitus, Type 1 - blood
Diabetes Mellitus, Type 1 - drug therapy
Glucose
Glycated Hemoglobin A - metabolism
Hemoglobin
Hormones - blood
Hospitals
Humans
Hyperglycemia
Hyperglycemia - drug therapy
Hypoglycaemia
Hypoglycemia
Hypoglycemia - prevention & control
Hypoglycemic Agents - administration & dosage
Insulin
Insulin - administration & dosage
Insulin - therapeutic use
Insulin Infusion Systems - adverse effects
Ketosis
Monitoring, Physiologic - methods
Outcome Assessment (Health Care)
Patient satisfaction
Pediatrics
Predictive low glucose suspend
Prevention
Quality of Life
Questionnaires
Safety
sensor-augmented pump therapy
Sensors
suspend before low
Teenagers
Treatment Outcome
Type 1 diabetes
Young Adult
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Summary:IntroductionInnovations with sensor-augmented pump therapy (SAPT) to reduce hypoglycaemia in patients with type 1 diabetes are an ongoing area of research. The predictive low glucose management (PLGM) system incorporates continuous glucose sensor data into an algorithm and suspends basal insulin before the occurrence of hypoglycaemia. The system was evaluated in in-clinic studies, and has informed the parameters of a larger home trial to study its efficacy and safety in real life.Methods and analysisThe aim of this report is to describe the study design and outcome measures for the trial. This is a 6-month, multicentre, randomised controlled home trial to test the PLGM system in children and adolescents with type 1 diabetes. The system is available in the Medtronic MiniMed 640G pump as the ‘Suspend before low’ feature. Following a run-in period, participants are randomised to either the control arm with SAPT alone or the intervention arm with SAPT and Suspend before low. The primary aim of this study is to evaluate the time spent hypoglycaemic (sensor glucose
ISSN:2044-6055
2044-6055
DOI:10.1136/bmjopen-2016-011589