Sudden Death Associated with Severe Hypoglycemia in a Diabetic Patient During Sensor-Augmented Pump Therapy with the Predictive Low Glucose Management System

Nishihama, Kota; Eguchi, Kazuhito; Maki, Kanako; Okano, Yuko; Tanaka, Soichiro; Inoue, Chisa; Uchida, Akihiro; Uemura, Mei; Suzuki, Tomohiko; Yasuma, Taro; D’Alessandro-Gabazza, Corina N.; Gabazza, Esteban C.; Yano, Yutaka

doi:10.12659/ajcr.928090

Cited by 11 publications

(9 citation statements)

References 21 publications

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“…This case, along with a previously reported death because of severe hypoglycaemia in a sensor-augmented pump user with predictive low-glucose suspend functionality, 9 serves as a timely reminder that severe hypoglycaemia remains a risk for individuals using automated insulin delivery systems, particularly in situations where this risk is amplified, such as alcohol consumption and increased activity. Figure 1 shows a significant increase in his automated basal insulin delivery between 3 am and 7 am on July 14th, in comparison to the 12 am to 7 am period on July 13th.…”

Section: E T T E Rmentioning

confidence: 71%

Severe hypoglycaemia while using a hybrid closed‐loop insulin pump system: A reminder of the continued importance of patient education for pre‐emptive hypoglycaemia mitigation

et al. 2022

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Section: E T T E Rmentioning

confidence: 71%

Severe hypoglycaemia while using a hybrid closed‐loop insulin pump system: A reminder of the continued importance of patient education for pre‐emptive hypoglycaemia mitigation

et al. 2022

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“…29.30 Despite the success of these strategies, and the increasing sophistication of technological approaches to insulin replacement, there is still a need for new approaches. Anecdotal evidence of severe hypoglycaemia in people with diabetes who are on the most advanced technology persists, 31,32 and all the studies that show reduced severe hypoglycaemia in populations at high risk by education or technology show residual severe hypoglycaemia episodes. 5,20,21,24,25 In populations with IAH, technology has often failed to restore awareness.…”

Section: The Management Of Iahmentioning

confidence: 99%

Impaired awareness of hypoglycaemia

Amiel

2022

Br J Diabetes

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Impaired awareness of hypoglycaemia (IAH), defined either clinically as the loss of subjective awareness of hypoglycaemia before the onset of cognitive impairment or biochemically as the loss of symptom perception until plasma glucose has fallen below 3 mmol/L (54 mg/dl), is the major modifiable risk factor for severe hypoglycaemia in T1DM and possibly in insulin-treated T2DM. This paper tells the story of IAH, its pathogenesis and its implications and the treatment strategies used to address it.

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“…Technological failures can manifest as adverse clinical events 2 ; researchers have described respiratory compromise resulting from malfunctioning vagal nerve stimulators, 8 cardiac arrests due to faults in ventilators 9 and patient deaths from errors in diabetic pumps. 10 A seminal work from Dameff et al described high-fidelity clinical simulations based on pathologies secondary to ‘hacked’ medical devices, highlighting the risks of compromised bedside infusion pumps, automated internal cardioverter defibrillators, and insulin delivery devices. 1 Since this research, real-life cases have been reported in the media, including an incident in the UK of a domestic assault enacted via a Bluetooth-connected insulin pump.…”

Section: Introductionmentioning

confidence: 99%

Simulation-based research for digital health pathologies: A multi-site mixed-methods study

Straw,

Dobbin,

Luna-Reaver

et al. 2024

DIGITAL HEALTH

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Background The advance of digital health technologies has created new forms of potential pathology which are not captured in current clinical guidelines. Through simulation-based research, we have identified the challenges to clinical care that emerge when patients suffer from illnesses stemming from failures in digital health technologies. Methods Clinical simulation sessions were designed based on patient case reports relating to (a) medical device hardware errors, (b) medical device software errors, (c) complications of consumer technology and (d) technology-facilitated abuse. Clinicians were recruited to participate in simulations at three UK hospitals; audiovisual suites were used to facilitate group observation of simulation experience and focused debrief discussions. Invigilators scored clinicians on performance, clinicians provided individual qualitative and quantitative feedback, and extensive notes were taken throughout. Findings Paired t-tests of pre and post-simulation feedback demonstrated significant improvements in clinician's diagnostic awareness, technical knowledge and confidence in clinical management following simulation exposure (p < 0.01). Barriers to care included: (a) low suspicion of digital agents, (b) attribution to psychopathology, (c) lack of education in technical mechanisms and (d) little utility of available tests. Suggested interventions for improving future practice included: (a) education initiatives, (b) technical support platforms, (c) digitally oriented assessments in hospital workflows, (d) cross-disciplinary staff and (e) protocols for digital cases. Conclusion We provide an effective framework for simulation training focused on digital health pathologies and uncover barriers that impede effective care for patients dependent on technology. Our recommendations are relevant to educators, practising clinicians and professionals working in regulation, policy and industry.

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Sudden Death Associated with Severe Hypoglycemia in a Diabetic Patient During Sensor-Augmented Pump Therapy with the Predictive Low Glucose Management System

Cited by 11 publications

References 21 publications

Severe hypoglycaemia while using a hybrid closed‐loop insulin pump system: A reminder of the continued importance of patient education for pre‐emptive hypoglycaemia mitigation

Severe hypoglycaemia while using a hybrid closed‐loop insulin pump system: A reminder of the continued importance of patient education for pre‐emptive hypoglycaemia mitigation

Impaired awareness of hypoglycaemia

Simulation-based research for digital health pathologies: A multi-site mixed-methods study

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