Relationship between participant-reported outcomes, residual beta cell function and metabolic parameters in youth with newly diagnosed type 1 diabetes
Authors' conclusion
PedsQL and HFS scores changed little during the first 48 months after diagnosis of type 1 diabetes. These scores showed modest but statistically significant associations with measures of glucose management (HbA1c and CGM time in range), whereas the relationships with residual beta cell function (C-peptide) were weaker and did not reach significance.
Study context
- Population
- Participants aged 10–18 years with newly diagnosed T1D and their parents
- Participants
- 97 vs 72
- Comparison
- Participant-reported outcome measures (PROMs) vs residual beta cell function, HbA1c and continuous glucose monitoring (CGM)
- CLOuDn = 97
- USTEKIDn = 72
Methodological detailspooled analysis of two clinical trials, repeated measures, meta-analysis across trials
- Pooled analysis of two clinical trials
- Repeated measures
- Meta-analysis across trials
Primary result
As reported in the abstract
- HbA1c and PedsQL, β(std)
- −0.11 (−0.20, −0.03) (95% CI)
- HbA1c and hypoglycaemia fear survey (HFS), β(std)
- 0.11 (0.00, 0.21) (95% CI)
- CGM time in range and PedsQL, β(std)
- 0.14 (0.03, 0.26) (95% CI)
- CGM time in range and HFS (not significant), β(std)
- −0.05 (−0.16, 0.06) (95% CI)
- AUC C-peptide and HbA1c, β(std)
- −0.29 (−0.39, −0.20) (95% CI)
- AUC C-peptide and CGM time in range, β(std)
- 0.41 (0.30, 0.52) (95% CI)
- Higher beta cell function and PedsQL (not significant), β(std)
- 0.11 (−0.03, 0.25) (95% CI)
- Higher beta cell function and HFS (not significant), β(std)
- −0.05 (−0.17, 0.07) (95% CI)
Further findings
Change in PedsQL and HFS scores over time · first 48 months from diagnosis
- Baseline scores highly predictive of scores at 12-48 months
- P < 0.001
- Wide variation between individuals but no substantial change within individuals
Child vs parent scores
- PedsQL higher (better) by children/adolescents than parents
- P < 0.01
- HFS higher in parents than children, indicating more fear
- P < 0.001
- Strong correlations between child and parent scores
- P < 0.001
Effect of intervention on PROMs
- No significant improvement in scores following intervention (ustekinumab or HCL)
Original publication
Relationship between participant-reported outcomes, residual beta cell function and metabolic parameters in youth with newly diagnosed type 1 diabetes. Diabetologia. Published 17 July 2026. doi:10. 1007/ s00125-026-06798-z
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