Schedule for visits
All | IIT group | DIT group | |||||
---|---|---|---|---|---|---|---|
Pre inclusion visit | Inclusion visit | Waiting period | Post-transplantation period | Delayed period | Waiting period | Post-transplantation period | |
Parameters recorded | Quarterly visit | Monthly visit | Quarterly visit | Quarterly visit | Monthly visit | ||
Medical evaluation | |||||||
Height | x | x | x | x | x | x | x |
Weight | x | x | x | x | x | x | x |
Insulin requirement | x | x | x | x | x | x | x |
Clarke score | x | ||||||
LBGI, MAGE index | x | ||||||
Hyposcore | x | ||||||
Adverse events | x | x | x | x | x | ||
Biological evaluation | |||||||
HbA1c | x | x | x | x | x | x | x |
C-peptide | x | x | x | x | |||
Creatinine | x | x | x | x | x | x | x |
Proteinuria | x | x | x | x | x | x | x |
Anti-HLA Ab | x | x | x | x | x | x | x |
Anti-GAD, anti-IA2 Ab | x | x | x | x | x | x | x |
Complete blood count | x | x | x | x | x | x | x |
ASAT/ALAT | x | x | x | x | x | x | x |
CGM recording | |||||||
One-month CGM recording | x | x M6–M12 post-transplantation | x M6–M12 post-inclusion | x M6–M12 post-transplantation | |||
Questionnaire | |||||||
DQoL | x | x M12 post-transplantation | x M12 post-inclusion | ||||
EQ-5D | x | x | x M6–M12 post-transplantation | x | x | X M6–M12 post-transplantation |
Ab, antibodies; ASAT/ALAT, aspartate amino transferase/alanine amino transferase; CGM, continuous glucose monitoring; DIT, delayed islet transplantation; DQoL, Diabetes Quality of Life; EQ-5D, EuroQol 5 Dimensions; GAD, glutamic acid decarboxylase; HbA1c, glycated haemoglobin; HLA, human leucocyte antigen; LBGI, low blood glucose index; MAGE, mean amplitude of glucose excursion.