A retrospective observational study of people with Type 1 diabetes with self‐reported severe hypoglycaemia reveals high level of ambulance attendance but low levels of therapy change and specialist intervention

Field, Benjamin; Nayar, Rahul; Kilvert, Anne; Baxter, Mike; Hickey, Joe; Cummings, MH; Baín, Steve

doi:10.1111/dme.13670

Cited by 6 publications

(7 citation statements)

References 24 publications

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“…Despite development of effective hypoglycaemia pathways within emergency departments and ambulance services to primary, community and secondary care services for early review [24–26], it has been reported that there are low levels of follow-up, therapy change and specialist input following an episode of hypoglycaemia [27]. This is in line with the clinical experience of the authors.…”

Section: Introductionsupporting

confidence: 69%

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

et al. 2019

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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.DiscussionThis 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).

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Section: Introductionsupporting

confidence: 69%

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

et al. 2019

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“…Even severe hypoglycaemia may not be captured in clinical notes or routine clinical review; episodes requiring Accident and Emergency department visits or hospitalization have been shown to go unreported to the direct care team in other real-world studies [15]. Even severe hypoglycaemia may not be captured in clinical notes or routine clinical review; episodes requiring Accident and Emergency department visits or hospitalization have been shown to go unreported to the direct care team in other real-world studies [15].…”

Section: Discussionmentioning

confidence: 99%

“…It is well known that hypoglycaemia is under-reported and poorly recorded. Even severe hypoglycaemia may not be captured in clinical notes or routine clinical review; episodes requiring Accident and Emergency department visits or hospitalization have been shown to go unreported to the direct care team in other real-world studies [15]. Data concerning hypoglycaemic events should be interpreted with caution in that 91% of participants prior to U300 initiation and 88% post-initiation of U300 had no documented mention of hypoglycaemia.…”

Section: Discussionmentioning

confidence: 99%

A multicentre, UK, retrospective, observational study to assess the effectiveness of insulin glargine 300 units/ml in treating people with Type 1 diabetes mellitus in routine clinical practice (SPARTA)

et al. 2018

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Aim To conduct an open‐label study to provide UK real‐world evidence regarding the use of insulin glargine 300 units/ml (U300) in people with Type 1 diabetes mellitus. Methods People with Type 1 diabetes who had been prescribed U300 ≥6 months before data collection and had HbA1c levels recorded within 3 months prior to U300 (baseline) were included. The primary endpoint was change in HbA1c from baseline to month 6 after U300 initiation. Other endpoints included number of documented hypoglycaemic and diabetic ketoacidosis episodes, and change in daily basal insulin dose. Results A total of 298 people with Type 1 diabetes were included [mean age 42.1 years, mean HbA1c 79 mmol/mol (9.4%)]. After U300 initiation, the mean reduction in HbA1c from baseline to month 6 was –4 mmol/mol (–0.4%; P<0.001; n=188). The total daily basal insulin dose at 6 months was 1.3 units higher than at the time of U300 initiation (P<0.001; n=275) but was not significantly different from the prior basal insulin dose. There was no clinically significant difference in weight between baseline and month 6 [mean difference +0.7 kg, 95% CI –0.1, 1.5; P=0.084; n=115). During the 6 months before and after U300 initiation, severe hypoglycaemic episodes were documented for 6/298 and 4/298 participants. Diabetic ketoacidosis episodes requiring Accident and Emergency department visits or hospitalization were documented for 4/298 and 6/298 participants, before and after U300 initiation, respectively. Conclusions In people with Type 1 diabetes, a change in basal insulin to U300 was associated with clinically and statistically significant HbA1c improvements, without significant changes in basal insulin dose and weight. Documented severe hypoglycaemia episodes and diabetic ketoacidosis requiring Accident and Emergency department visits or hospitalization were low and similar before and after U300 initiation.

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“…The study by Field et al [2] therefore makes worrying reading. The study by Field et al [2] therefore makes worrying reading.…”

mentioning

confidence: 98%

“…Given the clinical consequences of hypoglycaemia, one might have expected that efforts would be made to prevent further occurrences following an episode of severe hypoglycaemia. The study by Field et al [2] therefore makes worrying reading. They reported what happened after 140 episodes of severe hypoglycaemia in 85 people with Type 1 diabetes over a 2-year period.…”

mentioning

confidence: 98%

Hypoglycaemia: under‐reported and under‐treated

Holt

2018

Diabet. Med.

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A retrospective observational study of people with Type 1 diabetes with self‐reported severe hypoglycaemia reveals high level of ambulance attendance but low levels of therapy change and specialist intervention

Cited by 6 publications

References 24 publications

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

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

A multicentre, UK, retrospective, observational study to assess the effectiveness of insulin glargine 300 units/ml in treating people with Type 1 diabetes mellitus in routine clinical practice (SPARTA)

Hypoglycaemia: under‐reported and under‐treated

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