Efficacy and safety of continuous glucose monitoring on glycaemic control in patients with chronic pancreatitis and insulin-treated diabetes: A randomised, open-label, crossover trial

Aims: Continuous glucose monitoring (CGM) improves glycaemic control and reduces hypoglycaemia in type 1 and 2 diabetes, but its role in managing diabetes in chronic pancreatitis is unknown. We aimed to investigate the effect of CGM compared to self-monitoring of blood glucose (SMBG) on hypoglycaemia and glycaemic control in patients with chronic pancreatitis and insulin-treated diabetes. Materials and Methods: In a randomised, open-label, crossover trial, 30 participants with chronic pancreatitis and insulin-treated diabetes were randomised to 50 days of CGM or SMBG, separated by a 20-day washout period. The primary endpoint was time in level 2 hypoglycaemia (<3.0 mmol/L). Secondary endpoints included additional CGM metrics, HbA1c, daily insulin dose, questionnaires, and safety outcomes. Results: Twenty-nine participants completed the trial (mean age 64.4 +/- 8.8 years; 22 men [75.9%]). There was a numerical reduction in time spent in level 2 hypoglycaemia with CGM compared to SMBG (mean difference -0.36%, 95% confidence interval (CI) -0.78% to 0.06%; p = 0.09). CGM improved time in range (3.9-10.0 mmol/L; mean difference 7.46%, 95% CI 1.67% to 13.25%; p = 0.01), reduced time above range (>10.0 mmol/L; mean difference -6.55%, 95% CI -12.59% to -0.51%; p = 0.04), and reduced time below range (<3.9 mmol/L; mean difference -0.91%, 95% CI -1.79% to -0.03%; p = 0.04) compared to SMBG. No differences were observed for the safety endpoints. Conclusions: In patients with chronic pancreatitis and insulin-treated diabetes, CGM increased time in range and reduced time above and below range. These findings highlight the potential of CGM in improving glycaemic control.