Hybrid closed-loop insulin therapy and risk of severe hypoglycaemia and diabetic ketoacidosis in young people (aged 2–20 years) with type 1 diabetes: a population-based study
Authors' conclusion
Hybrid closed-loop insulin delivery has no significant effect on the rate of severe hypoglycaemia, and is associated with an increased risk of diabetic ketoacidosis, but is associated with a reduced risk of hypoglycaemic coma and improved glycaemia. These findings indicate the need for additional educational measures for the use of closed-loop insulin delivery.
Study context
- Population
- Young people aged 2–20 years with T1D, diabetes duration >1 year, treated Jan 1, 2021–Dec 31, 2023, 250 diabetes centres in Germany, Austria, Switzerland and Luxembourg (DPV initiative)
- Participants
- 13,922 people
- Exposure
- Hybrid closed-loop vs sensor-augmented pump therapy
- Closed-loopn = 7,088
- Open-loopn = 6,834reference
- Outcome
- Rates of severe hypoglycaemia and ketoacidosis
- Follow-up
- Median observation time 1.6 years [IQR 1.1 to 2.4]
Methodological detailspropensity score inverse probability of treatment weighting, multicentre
- Propensity score inverse probability of treatment weighting
- Multicentre
Main finding
As reported in the abstract
Closed-loop
1.74 per 100 patient-years
Open-loop
0.96 per 100 patient-years
Closed-loop vs Open-loopIncidence rate ratio (95% CI)P value
Ketoacidosis
1.81(1.37–2.40)
P < 0.0001- Severe hypoglycaemia; no significant difference
- IRR 0.84 (95% CI 0.69–1.03); P = 0.089
Observational data: associations, not effects.
Secondary outcomes
Per 100 patient-years
| Outcome | Closed-loop | Open-loop | IRR (95% CI) | P value | |
|---|---|---|---|---|---|
| Hypoglycaemic coma | 0.62 | 0.91 | 0.68 (0.48–0.97) | P = 0.034 | |
| Ketoacidosis in subgroup with HbA1c ≥8.5% | 5.25 | 1.53 | 3.43 (1.69–6.97) | P < 0.0001 | |
| 0.10.31310Incidence rate ratio (log scale) |
%
| Outcome | Closed-loop | Open-loop | Difference, % | P value | |
|---|---|---|---|---|---|
| HbA1c | 7.34 | 7.50 | −0.16 (95% CI −0.20 to −0.13) | P = 0.0007 | |
| TIR 3.9-10.0 mmol/L | 64 | 52 | 12 (CI 10–14) | P < 0.0001 | |
| Glycaemic variability (CV) | 35.4 | 38.3 | −2.9 (CI −3.3 to −2.5) | P < 0.0001 | |
| −1001020Difference, % (linear scale) |
Safety
Per 100 patient-years
| Outcome | Closed-loop | Open-loop | IRR (CI) | P value | |
|---|---|---|---|---|---|
| DKA (harm) | 1.74 | 0.96 | 1.81 (1.37–2.40) | P < 0.0001 | |
| 0.512Incidence rate ratio (log scale) |
Original publication
Hybrid closed-loop insulin therapy and risk of severe hypoglycaemia and diabetic ketoacidosis in young people (aged 2–20 years) with type 1 diabetes: a population-based study. Lancet Diabetes Endocrinol. Published 16 December 2024. doi:10.
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