Estimating risk of consequences following hypoglycaemia exposure using the Hypo-RESOLVE cohort: a secondary analysis of pooled data from insulin clinical trials
Authors' conclusion
These data are consistent with hypoglycaemia being associated with an increased risk of adverse events across several body systems in diabetes. These associations are not confined to severe hypoglycaemia requiring assistance.
Study context
- Population
- People with T1D or T2D in insulin clinical trials (Hypo-RESOLVE cohort)
- Participants
- 39,373 people84 trials
- Comparison
- Exposure to hypoglycaemia vs no exposure
- Primary endpoint
- Incident events (death, CVD, neuropathy, kidney disease, retinal disorders, depression) by cumulative hypoglycaemia exposure and by hypoglycaemia in the previous 10 days
Methodological detailspooled individual data, time-updated Cox regression, analysed separately by type of diabetes, Median follow-up for continuous outcomes 40.4 weeks (T1D) and 26 weeks (T2D)
- Pooled individual data
- Time-updated Cox regression
- Analysed separately by type of diabetes
- Median follow-up for continuous outcomes 40.4 weeks (T1D) and 26 weeks (T2D)
Primary result
As reported in the abstract
T1D: higher risks of neuropathy, kidney disease, retinal disorders and depression; risk ratios from
1.55 (p=0.002) to 2.81
p=0.002
T2D: higher risks of death, acute CVD, kidney disease, retinal disorders and depression; risk ratios from
2.35 (p<0.0001) to 3.00
p<0.0001
Further findings
Any hypoglycaemia in previous 10 days and death, acute CVD and retinal disorders (T1D and T2D)
- Rate ratios ranging from
- 1.32 (p=0.017) to 2.68 (p<0.0001)
- Associations varied in magnitude and significance by hypoglycaemia level
Threshold of risk across hypoglycaemia levels 1–3
- No evidence of a threshold at which risk became pronounced
Original publication
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