Early Worsening of Diabetic Retinopathy Following Initiation of Hybrid Closed‐Loop/Automated Insulin Delivery Systems in Type 1 Diabetes: A Systematic Review and Structured Study‐Level Synthesis
Authors' conclusion
Study-defined retinal worsening was reported in a minority of participants.
Study context
- Population
- People with T1D initiating any hybrid closed-loop (HCL) system; observational studies reporting retinal outcomes, searched to 14th May 2026
- Participants
- 1,487 people8 studies
- Comparison
- HCL initiation vs control therapy
- HCLn = 860
- Outcome
- Early worsening of diabetic retinopathy (EWDR) incidence
Methodological detailsno pooled or meta-analytic estimates, ROBINS-I risk of bias, GRADE certainty, All 8 studies observational; 6 retrospective
- No pooled or meta-analytic estimates
- ROBINS-I risk of bias
- GRADE certainty
- All 8 studies observational; 6 retrospective
Pooled result
As reported in the abstract
EWDR rate, retina assessed ≤12 months after HCL initiation · ≤ 12 months
HCL
8.9% to 26.5%
Further pooled results
| Outcome | HCLn = 177 | Controln = 315 | Study-specific RR range |
|---|---|---|---|
| EWDR, comparative studies (3 studies)Directionally inconsistent; not pooled | n = 177 | n = 315 | 0.32 to 1.51 |
Retinal worsening or incident DR, longer follow-up · 24 months; mean 4.9 years
- Rate at 24 months
- 6.7%
- Rate over mean follow-up of 4.9 years
- 6.1%
- May capture background DR progression rather than true early worsening
Risk factors for early worsening of diabetic retinopathy (EWDR)
- Most consistent risk factors: higher baseline HbA1c and older age
- Magnitude of HbA1c reduction not a consistent predictor of EWDR in HCL context
Risk of bias and certainty of evidence
- Risk of bias moderate to critical; certainty very low for all outcomes
Original publication
Early Worsening of Diabetic Retinopathy Following Initiation of Hybrid Closed‐Loop/Automated Insulin Delivery Systems in Type 1 Diabetes: A Systematic Review and Structured Study‐Level Synthesis. Diabetes Obes Metab. Published 8 July 2026. doi:10.
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