Evidence map›Paper›PMID 31655586›Full record

ArticleBMC endocrine disorders2019

Rationale and protocol for the Assessment of Impact of Real-time Continuous Glucose Monitoring on people presenting with severe Hypoglycaemia (AIR-CGM) study.

Parizad Avari, Rozana Ramli, Monika Reddy, Nick Oliver, Rachael Fothergill

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in BMC endocrine disorders, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03748433 (Assessment of the Impact of Real-Time Continuous Glucose Monitoring on People Presenting With Severe Hypoglycaemia), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

NCT03748433 naterminatednot on this map

Assessment of the Impact of Real-Time Continuous Glucose Monitoring on People Presenting With Severe Hypoglycaemia

TypeinterventionalSponsorImperial College LondonRan2019 to 2021Enrolled35ConditionsDiabetes Mellitus, Type 1, Hypoglycemia Unawareness, HypoglycemiaArmsDexcom G6 CGM, Tandem t:slim X2 Insulin Pump
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. 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

5 authors.

Parizad AvariDivision of Diabetes, Endocrinology and Metabolism, Faculty of Medicine, Imperial College, 7S7a, Commonwealth Building, Hammersmith Campus, Du Cane Road, W12 0HS, London, UK.
Rozana RamliDivision of Diabetes, Endocrinology and Metabolism, Faculty of Medicine, Imperial College, 7S7a, Commonwealth Building, Hammersmith Campus, Du Cane Road, W12 0HS, London, UK.
Monika ReddyDivision of Diabetes, Endocrinology and Metabolism, Faculty of Medicine, Imperial College, 7S7a, Commonwealth Building, Hammersmith Campus, Du Cane Road, W12 0HS, London, UK.
Nick OliverDivision of Diabetes, Endocrinology and Metabolism, Faculty of Medicine, Imperial College, 7S7a, Commonwealth Building, Hammersmith Campus, Du Cane Road, W12 0HS, London, UK. nick.oliver@imperial.ac.uk.
Rachael FothergillClinical Audit & Research Unit, London Ambulance Service NHS Trust, London, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSevere hypoglycaemia carries a significant risk of morbidity and mortality for people with type 1 diabetes. Economic costs are also high, estimated at approximately £13 million annually in England, UK. Continuous glucose monitoring (CGM) has been shown to reduce hypoglycaemia and associated fear, improve overall glycaemia and quality of life, and is cost-effective. Despite effective pathways in place with high levels of resource utilization, it has been reported there are low levels of follow-up, therapy change and specialist intervention after severe hypoglycaemia. This study is designed to assess the impact of providing real-time CGM to people with type 1 diabetes, who have had a recent episode of severe hypoglycaemia (within 72 h), compared to standard care. METHODS/

designFifty-five participants with type 1 diabetes and a recent episode of severe hypoglycaemia, who are CGM naïve, will be recruited to the study. Participants will be randomised to CGM or standard care. The primary outcome is percentage time spent in hypoglycaemia (< 3.0 mmol/L, 55 mg/dL). Secondary outcomes include other measures of hypoglycaemia, time in euglycaemia, overall glucose status and patient reported qualitative measures. DISCUSSION: This study assesses the impact of providing continuous glucose monitoring at the outset in individuals at highest risk of hypoglycaemia. Changing demand means that novel approaches need to be taken to healthcare provision. This study has the potential to shape future national standards.

trial registrationNCT03748433 , November 2018 (UK).

Indexed as

Blood GlucoseBlood Glucose Self-MonitoringDiabetes Mellitus, Type 1HypoglycemiaHypoglycemic AgentsQuality of LifeRisk AssessmentAdolescentBiomarkersFemaleFollow-Up StudiesGlycated HemoglobinHumansMaleMonitoring, AmbulatoryPrognosisBiomarkersBlood GlucoseGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsContinuous glucose monitoringSevere hypoglycaemiaType 1 diabetes

Identifiers

PMID31655586
PMCPMC6815361

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Registered trials

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.