Journal of Endocrinological Investigation最新文献

Purpose: DBLG1 is a hybrid closed-loop (CL) system interoperable with ViCentra Kaleido and Roche Insight pumps. The SP8 trial investigated the safety and glycemic outcomes of DBLG1 coupled to the DANA-i pump (DBLG1-DANAi) in adults and adolescents with type 1 diabetes mellitus (T1D).

Methods: The safety of DBLG1-DANAi (primary outcome of SP8) was evaluated using two criteria: (i) the incidence of serious adverse device events (SADEs) and (ii) the time spent in hypoglycemia (time below range 70 mg/dL [3.9 mmol/L], TBR70) with DBLG1-DANAi compared to an SAP (sensor-augmented pump) system. Secondary outcomes included non-serious adverse events and standard glycemic metrics. Five months after its start, the trial was halted due to the COVID-19 crisis. One hundred and forty (140) of the 148 planned adults had already been included in the study, as well as all planned adolescents (N = 36).

Results: The intention-to-treat (ITT) population included 105 adult and 36 adolescent participants in whom no SADE was observed with DBLG1-DANAi. The per-protocol (PP) population consisted of 73 adults and 18 adolescents who spent two weeks with SAP, followed by two weeks with DBLG1-DANAi. No increase in TBR70 was observed during the DBLG1-DANAi period. Furthermore, the time spent in the glucose level range of 70-180 mg/dL [3.9-10.0 mmol/L] (time in range, TIR70-180) ​​increased significantly with DBLG1-DANAi, both in adults (+ 10.5%; p < 0.0001) and adolescents (+ 16.0%; p < 0.0001).

Conclusion: During the two-week study period, DBLG1 was interoperable with the DANA-i pump. This result requires confirmation in future long-term studies.

Clinicaltrials:

Gov id: NCT04190277.

Purpose: This study aimed to evaluate the one-year metabolic and renal effects of combined therapy with SGLT-2 inhibitors and GLP-1 receptor (GLP-1R) agonists in patients with type 2 diabetes mellitus (T2DM), both with and without diabetic kidney disease (DKD). The primary objective was to assess changes in BMI, HbA1c, LDL-C, eGFR, and UACR in a real-world setting.

Methods: A retrospective analysis was conducted on 250 patients with type 2 diabetes mellitus (T2DM) treated with SGLT-2 inhibitors and GLP-1 receptor agonists at the Diabetology Service of CTO-Alesini Hospital, Rome, between 2022 and 2025. Metabolic and renal parameters were collected at baseline and after 12 months. Patients were stratified according to the presence of diabetic kidney disease (DKD). The primary outcomes included changes in BMI, HbA1c, LDL-C, eGFR, and UACR. Secondary analyses evaluated the impact of adding an SGLT-2 inhibitor to pre-existing GLP-1 receptor agonist therapy, or vice versa.

Results: After 12 months, we observed significant reductions in BMI (p = 0.03), HbA1c (p < 0.001), LDL-C (p < 0.01), and UACR (p < 0.001). In patients with DKD (46% of the cohort), UACR improved markedly (p < 0.001), while eGFR remained stable. Significant reductions in HbA1c (p < 0.001) and LDL-C (p < 0.01) were also observed. In non-DKD patients, HbA1c and LDL-C decreased after one year, with eGFR remaining within the normal range. Importantly, among DKD patients, the addition of an SGLT-2 inhibitor to GLP-1 receptor agonist therapy resulted in significant reductions in both HbA1c (p = 0.04) and UACR (p < 0.01), whereas the addition of a GLP-1 receptor agonist primarily reduced HbA1c (p < 0.01). In non-DKD patients, both treatment sequences improved HbA1c and LDL-C.

Conclusion: Dual therapy with SGLT-2 inhibitors and GLP-1 receptor agonists was associated with improvements in glycemic control, lipid profile, and albuminuria, particularly among patients with DKD. The sequence of drug addition appeared to influence outcomes, with the addition of SGLT-2 inhibitors providing superior renal benefits in DKD. These findings may provide support for early combined use of both agents in high-risk patients with T2DM.

This piece reflects on Frida Kahlo-the iconic Mexican painter whose art and life remain profoundly intertwined-through the lens of endocrinology. In works such as Self-Portrait with Monkey and Parrot, Kahlo presents herself with features suggestive of mild hirsutism, including her distinctive monobrow and faint upper-lip hair. The essay explores how her distinctive features, often interpreted as signs of androgen excess, may instead represent an assertion of cultural identity and aesthetic autonomy.