Beta cell function in type 1 diabetes determined from clinical and fasting biochemical variables.
Diabetologia
; 62(1): 33-40, 2019 01.
Article
in En
| MEDLINE
| ID: mdl-30167735
ABSTRACT
AIMS/HYPOTHESIS:
Beta cell function in type 1 diabetes is commonly assessed as the average plasma C-peptide concentration over 2 h following a mixed-meal test (CPAVE). Monitoring of disease progression and response to disease-modifying therapy would benefit from a simpler, more convenient and less costly measure. Therefore, we determined whether CPAVE could be reliably estimated from routine clinical variables.METHODS:
Clinical and fasting biochemical data from eight randomised therapy trials involving participants with recently diagnosed type 1 diabetes were used to develop and validate linear models to estimate CPAVE and to test their accuracy in estimating loss of beta cell function and response to immune therapy.RESULTS:
A model based on disease duration, BMI, insulin dose, HbA1c, fasting plasma C-peptide and fasting plasma glucose most accurately estimated loss of beta cell function (area under the receiver operating characteristic curve [AUROC] 0.89 [95% CI 0.87, 0.92]) and was superior to the commonly used insulin-dose-adjusted HbA1c (IDAA1c) measure (AUROC 0.72 [95% CI 0.68, 0.76]). Model-estimated CPAVE (CPEST) reliably identified treatment effects in randomised trials. CPEST, compared with CPAVE, required only a modest (up to 17%) increase in sample size for equivalent statistical power. CONCLUSIONS/INTERPRETATION:
CPEST, approximated from six variables at a single time point, accurately identifies loss of beta cell function in type 1 diabetes and is comparable to CPAVE for identifying treatment effects. CPEST could serve as a convenient and economical measure of beta cell function in the clinic and as a primary outcome measure in trials of disease-modifying therapy in type 1 diabetes.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Fasting
/
Diabetes Mellitus, Type 1
Type of study:
Clinical_trials
/
Prognostic_studies
Limits:
Female
/
Humans
/
Male
Language:
En
Journal:
Diabetologia
Year:
2019
Type:
Article
Affiliation country:
Australia