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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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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cited_by cdi_FETCH-LOGICAL-b578t-9a389f5de0b3f5502884bde17d80426d62d670f6fc7d1c9d8ee62cad6892bd03
cites cdi_FETCH-LOGICAL-b578t-9a389f5de0b3f5502884bde17d80426d62d670f6fc7d1c9d8ee62cad6892bd03
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container_issue 4
container_start_page e011589
container_title BMJ open
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creator 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
description 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
doi_str_mv 10.1136/bmjopen-2016-011589
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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 &lt;3.5 mmol/L) with and without the system. The secondary aims are to determine the number of hypoglycaemic events, the time spent hyperglycaemic, and to evaluate safety with ketosis and changes in glycated haemoglobin. The study also aims to assess the changes in counter-regulatory hormone responses to hypoglycaemia evaluated by a hyperinsulinaemic hypoglycaemic clamp in a subgroup of patients with impaired awareness. Validated questionnaires are used to measure the fear of hypoglycaemia and the impact on the quality of life to assess burden of the disease.Ethics and disseminationEthics committee permissions were gained from respective Institutional Review boards. The findings of the study will provide high quality evidence of the ability of the system in the prevention of hypoglycaemia in real life.Trial registration numberACTRN12614000510640, Pre-results.</description><identifier>ISSN: 2044-6055</identifier><identifier>EISSN: 2044-6055</identifier><identifier>DOI: 10.1136/bmjopen-2016-011589</identifier><identifier>PMID: 27084290</identifier><language>eng</language><publisher>England: British Medical Journal Publishing Group</publisher><subject>Adolescent ; Adult ; Blood Glucose - metabolism ; Caregivers ; Child ; Children &amp; 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 &amp; control ; Hypoglycemic Agents - administration &amp; dosage ; Insulin ; Insulin - administration &amp; 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</subject><ispartof>BMJ open, 2016-04, Vol.6 (4), p.e011589</ispartof><rights>Published by the BMJ Publishing Group Limited. 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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 &lt;3.5 mmol/L) with and without the system. The secondary aims are to determine the number of hypoglycaemic events, the time spent hyperglycaemic, and to evaluate safety with ketosis and changes in glycated haemoglobin. The study also aims to assess the changes in counter-regulatory hormone responses to hypoglycaemia evaluated by a hyperinsulinaemic hypoglycaemic clamp in a subgroup of patients with impaired awareness. Validated questionnaires are used to measure the fear of hypoglycaemia and the impact on the quality of life to assess burden of the disease.Ethics and disseminationEthics committee permissions were gained from respective Institutional Review boards. 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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 &lt;3.5 mmol/L) with and without the system. The secondary aims are to determine the number of hypoglycaemic events, the time spent hyperglycaemic, and to evaluate safety with ketosis and changes in glycated haemoglobin. The study also aims to assess the changes in counter-regulatory hormone responses to hypoglycaemia evaluated by a hyperinsulinaemic hypoglycaemic clamp in a subgroup of patients with impaired awareness. Validated questionnaires are used to measure the fear of hypoglycaemia and the impact on the quality of life to assess burden of the disease.Ethics and disseminationEthics committee permissions were gained from respective Institutional Review boards. The findings of the study will provide high quality evidence of the ability of the system in the prevention of hypoglycaemia in real life.Trial registration numberACTRN12614000510640, Pre-results.</abstract><cop>England</cop><pub>British Medical Journal Publishing Group</pub><pmid>27084290</pmid><doi>10.1136/bmjopen-2016-011589</doi><oa>free_for_read</oa></addata></record>
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source Open Access: PubMed Central; BMJ Journals (Open Access); Publicly Available Content (ProQuest); BMJ Journals
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
title 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
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