Clinical trials in newly diagnosed type 1 diabetes commonly use C-peptide area under the curve (AUCCp) from a mixed meal tolerance test (MMTT) as the primary endpoint. A study published in Diabetologia examined whether beta cell glucose sensitivity (βGS), a model-derived measure of in vivo beta cell function, could improve the evaluation of treatment effects in stage 3 type 1 diabetes trials.

The analysis included 4,930 MMTT measurements from 799 participants enrolled in nine Phase II trials involving individuals with stage 3 type 1 diabetes. The study evaluated whether βGS could complement AUCCp in assessing treatment responses during clinical trials.

Higher age and body mass index (BMI) were associated with maintenance of βGS, defined as a loss of less than 10% from baseline. These factors were also associated with maintaining hemoglobin A1c (HbA1c) below 53 mmol/mol (7.0%).

Baseline βGS, age, HbA1c, and insulin dose predicted the magnitude of HbA1c response after intervention. Comparisons between positive and negative trials showed that normalised βGS identified treatment effects earlier than AUCCp.

The analysis also identified thresholds of change in βGS associated with clinically significant effects on glycemic management after intervention. Baseline βGS combined with clinical and demographic characteristics may help identify individuals more likely to respond to therapeutic interventions.