Association between primary graft function and 5-year outcomes of islet allogeneic transplantation in type 1 diabetes: a retrospective, multicentre, observational cohort study in 1210 patients from the Collaborative Islet Transplant Registry
Main finding · Unsuccessful islet transplantationResult — go to the resultAdjusted subdistribution hazard ratio 0.77 95% CI 0.72–0.82Authors' conclusion
This global multicentre study reports a linear and independent association between PGF and 5-year clinical outcomes of islet transplantation. The main study limitations are its retrospective design and the absence of analysis of complications.
Study context
- Population
- Patients with T1D in the Collaborative Islet Transplant Registry receiving ITA or IAK (Jan 1999–July 2020) with calculable primary graft function (PGF), 39 centres; mean age 47 years, 59.5% female
- Participants
- 1,210 patients39 centres
- Exposure
- PGF per 5-unit increase
- ITAn = 986
- IAKn = 211
- Outcome
- Cumulative incidence of unsuccessful islet transplantation (HbA1c ≥7.0%, severe hypoglycaemia, or fasting C-peptide <0.2 ng/mL)
- Follow-up
- 5 years
Methodological detailsmulticentre, observational, registry-based, competing risk analysis
- Multicentre
- Observational
- Registry-based
- Competing risk analysis
Main finding
Unsuccessful islet transplantation
Adjusted subdistribution hazard ratio
0.77
95% CI 0.72–0.82
P < 0.0001
PGF per 5-unit increase of BETA-2 score
adjusted sHR 0.77 (95% CI 0.72–0.82); P < 0.0001
Per 5-unit increase of BETA-2 score, as printed
As reported in the abstract
- 5-year cumulative incidence of unsuccessful islet transplantation (all patients)
- 70.7% (95% CI 67.2-73.9)
Observational data: associations, not effects.
Secondary outcomes
Graft exhaustion, inadequate glucose control, exogenous insulin therapy · 5 years
- Secondary endpoints similarly related to PGF
Predictive performance of PGF (model-adjusted median C-statistic) · 5 years
- Unsuccessful islet transplantation
- 0.70 (range 0.69-0.71)
- Graft exhaustion
- 0.76 (0.74-0.77)
- Inadequate glucose control
- 0.65 (0.64-0.66)
- Exogenous insulin therapy
- 0.72 (0.71-0.73)
Original publication
Association between primary graft function and 5-year outcomes of islet allogeneic transplantation in type 1 diabetes: a retrospective, multicentre, observational cohort study in 1210 patients from the Collaborative Islet Transplant Registry. Lancet Diabetes Endocrinol. Published 24 April 2023. doi:10.
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