Evidence map›Paper›PMID 27084290›Full record

Trial reportBMJ open2016

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.

M B Abraham, J A Nicholas, T T Ly, H C Roby, N Paramalingam, J Fairchild, B R King, G R Ambler, F Cameron, E A Davis and 1 more

Abstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMJ open, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Trial
  2. Review
  3. Observational
  4. Review
  5. Article
  6. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

M B AbrahamDepartment of Endocrinology and Diabetes, Princess Margaret Hospital for Children, Perth, Western Australia, Australia School of Paediatrics and Child Health, The University of Western Australia, Perth, Western Australia, Australia.
J A NicholasTelethon Kids Institute, The University of Western Australia, Perth, Western Australia, Australia.
T T LyDepartment of Endocrinology and Diabetes, Princess Margaret Hospital for Children, Perth, Western Australia, Australia School of Paediatrics and Child Health, The University of Western Australia, Perth, Western Australia, Australia Telethon Kids Institute, The University of Western Australia, Perth, Western Australia, Australia.
H C RobyTelethon Kids Institute, The University of Western Australia, Perth, Western Australia, Australia.
N ParamalingamDepartment of Endocrinology and Diabetes, Princess Margaret Hospital for Children, Perth, Western Australia, Australia Telethon Kids Institute, The University of Western Australia, Perth, Western Australia, Australia.
J FairchildEndocrinology and Diabetes Centre, Women's and Children's Hospital, Adelaide, South Australia, Australia.
B R KingDepartment of Endocrinology and Diabetes, John Hunter Children's Hospital, Newcastle, New South Wales, Australia.
G R AmblerInstitute of Endocrinology and Diabetes, The Children's Hospital at Westmead and The University of Sydney, Sydney, New South Wales, Australia.
F CameronDepartment of Endocrinology and Diabetes, Royal Children's Hospital, Melbourne, Victoria, Australia.
E A DavisDepartment of Endocrinology and Diabetes, Princess Margaret Hospital for Children, Perth, Western Australia, Australia School of Paediatrics and Child Health, The University of Western Australia, Perth, Western Australia, Australia Telethon Kids Institute, The University of Western Australia, Perth, Western Australia, Australia.
T W JonesDepartment of Endocrinology and Diabetes, Princess Margaret Hospital for Children, Perth, Western Australia, Australia School of Paediatrics and Child Health, The University of Western Australia, Perth, Western Australia, Australia Telethon Kids Institute, The University of Western Australia, Perth, Western Australia, Australia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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 ANALYSIS: The 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 <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 DISSEMINATION: Ethics 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 NUMBER: ACTRN12614000510640, Pre-results.

Indexed as

Insulin Infusion SystemsAdolescentAdultBlood GlucoseChildDiabetes Mellitus, Type 1Glycated HemoglobinHormonesHumansHyperglycemiaHypoglycemiaHypoglycemic AgentsInsulinKetosisMonitoring, PhysiologicOutcome Assessment, Health CareBlood GlucoseGlycated HemoglobinHormonesHypoglycemic AgentsInsulinHypoglycaemiaPredictive low glucose suspendsensor-augmented pump therapysuspend before lowType 1 diabetes

Identifiers

PMID27084290
PMCPMC4838718

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.