Diabetes complications

Risk factors and prediction of hypoglycaemia using the Hypo-RESOLVE cohort: a secondary analysis of pooled data from insulin clinical trials

DiabetologiaPublished Secondary analysis of pooled data from insulin clinical trials

Authors' conclusion

Although hypoglycaemia rates show large variation according to sociodemographic and clinical characteristics and treatment history, looking at a 6 week period of hypoglycaemia events and glucose measurements predicts future hypoglycaemia risk.

Study context

Population
People with T1D or T2D in pooled insulin clinical trials across pharmaceutical and device companies (Hypo-RESOLVE)
Participants
46,254 people90 trials
Comparison
T1D vs T2D
Primary endpoint
Prediction (AUC) of incident hypoglycaemia events
Follow-up
Whole trial duration (mean 34.8 weeks T1D, 25.3 weeks T2D)
Methodological detailspooled individual participant data from 90 trials, Poisson mixed models, XGBoost prediction models
  • Pooled individual participant data from 90 trials
  • Poisson mixed models
  • XGBoost prediction models

Primary result

As reported in the abstract

Prediction of level 1 or worse hypoglycaemia · whole follow-up period
GroupAUC
T1D0.835 (95% CI 0.826, 0.844)
T2D0.840 (95% CI 0.831, 0.848)

AUC

T1D0.835 (95% CI 0.826, 0.844)
T2D0.840 (95% CI 0.831, 0.848)

Further findings

OutcomeT1DT2D
Prediction of level 3 hypoglycaemia (requiring assistance) · whole follow-up period
AUC0.689 (95% CI 0.667, 0.712)0.705 (95% CI 0.662, 0.748)

Factors associated with more frequent hypoglycaemia (T1D and T2D)

Female sex, white ethnicity, longer DM duration, human vs analogue-only insulin, higher glucose variability, higher 6-week baseline hypoglycaemia score, lower BP, lower lipid levels and psychoactive drugs were associated with more frequent hypoglycaemia

Sources of improvement in prediction over baseline models

Almost all improvement captured by hypoglycaemia history, glucose variability and blood glucose over a 6-week baseline period

Original publication

Risk factors and prediction of hypoglycaemia using the Hypo-RESOLVE cohort: a secondary analysis of pooled data from insulin clinical trials. Diabetologia. Published 25 May 2024. doi:10.1007/s00125-024-06177-6

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