Type 1 diabetes

Relationship between participant-reported outcomes, residual beta cell function and metabolic parameters in youth with newly diagnosed type 1 diabetes

DiabetologiaPublished Secondary analysis of the CLOuD and USTEKID randomised trials

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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