Background and Aims

Dapagliflozin is approved in the EU for patients with type 1 diabetes (T1D) with BMI ≥ 27 kg/m². Our aim was to evaluate its safety and efficacy on standardized CGM metrics in T1D patients using CGM.

Methods

We conducted a prospective study including all T1D patients with BMI ≥ 27 kg/m² using CGM who were precribed dapagliflozin 5 mg daily and were followed for at least 6 months. Education concerning ketosis prevention was given to all patients before initiating dapagliflozin. Weight, standardized CGM metrics and ketosis episodes were registered before and after 3 and 6 months of treatment. Data were analyzed with univariate repeated-measures ANOVA using SPSS Statistics.

Results

13 patients were included from November 2019 to July 2020: 5 were male and 8 female, 9 on insulin pump and 4 on multiple dose injections, 8 on real-time CGM and 5 on intermittently-scanned CGM, with baseline characteristics as follows: age 45.9±7.2 years, BMI 31±3.7 kg/m², HbA1c 7.5±0.7% and TIR 56.2±9.2%.

Medication was discontinued in 3 patients due to ketosis (n=2) and ketoacidosis (n=1). Patients who completed the 6 months period showed significant increase in TIR and a significant decrease in weight, BMI, TBR, TAR and CV, and a non-significant decrease in GMI and mean glucose (Table 1).

There were 8 ketotic decompensations and 1 ketoacidosis that required ICU care. 2 patients had mild urinary tract infections.

Conclusions

Dapagliflozin led to further improvement in CGM metrics in patients with T1D. Nevertheless, despite a structured ketone-prevention program, ketosis risk was increased.