PMID- 38197988 OWN - NLM STAT- MEDLINE DCOM- 20240404 LR - 20240405 IS - 1559-0100 (Electronic) IS - 1355-008X (Print) IS - 1355-008X (Linking) VI - 84 IP - 1 DP - 2024 Apr TI - Insulin pump treatment vs. multiple daily insulin injections in patients with poorly controlled Type 2 diabetes mellitus: a comparison of cardiovascular effects. PG - 128-135 LID - 10.1007/s12020-023-03651-w [doi] AB - AIMS: Both hyperglycaemia and large glycaemic variability are associated with worse outcomes in patients with Type 2 diabetes mellitus (T2DM), possibly causing sympatho-vagal imbalance and endothelial dysfunction. Continuous subcutaneous insulin injection (CSII) improves glycemic control compared to multiple daily insulin injections (MDI). We aimed to assess whether CSII may improve cardiac autonomic and vascular dilation function compared to MDI. METHODS: We enrolled T2DM patients without cardiovascular disease with poor glycaemic control, despite optimized MDI therapy. Patients were randomized to continue MDI (with multiple daily peripheral glucose measurements) or CSII; insulin dose was adjusted to achieve optimal target ranges of blood glucose levels. Patients were studied at baseline and after 6 months by: 1) flow-mediated dilation (FMD) and nitrate-mediated dilation (NMD) of the brachial artery; 2) heart rate variability (HRV) by 24-hour ECG Holter monitoring (HM). 7-day continuous glucose monitoring (CGM) was performed in 9 and 8 patients of Group 1 and 2, respectively. RESULTS: Overall, 21 patients were enrolled, 12 randomized to CSII (Group 1) and 9 to MDI (Group 2). The daily dose of insulin and Hb1AC did not differ significantly between the 2 groups, both at baseline and at follow-up. Glucose variability showed some significant improvement at follow-up in the whole population, but no differences were observed between the 2 groups. Both FMD and NMD, as well as HRV parameters, showed no significant differences between the 2 groups at 6-month follow-up. CONCLUSIONS: In this randomized small study we show that, in T2DM patients, CSII achieves a similar medium-term glycemic control compared to MDI, without any adverse effect on the cardiovascular system. CI - (c) 2024. The Author(s). FAU - Tremamunno, Saverio AU - Tremamunno S AD - Department. of Cardiovascular Sciences, Fondazione Policlinico Universitario A. Gemelli IRCCS, Universita Cattolica del Sacro Cuore, Rome, Italy. FAU - Tartaglione, Linda AU - Tartaglione L AD - Diabetes Care Unit, Internal Medicine, Fondazione Policlinico Universitario A. Gemelli IRCCS, Universita Cattolica del Sacro Cuore, Rome, Italy. FAU - Telesca, Alessandro AU - Telesca A AD - Department. of Cardiovascular Sciences, Fondazione Policlinico Universitario A. Gemelli IRCCS, Universita Cattolica del Sacro Cuore, Rome, Italy. FAU - Rizzi, Alessandro AU - Rizzi A AD - Diabetes Care Unit, Internal Medicine, Fondazione Policlinico Universitario A. Gemelli IRCCS, Universita Cattolica del Sacro Cuore, Rome, Italy. FAU - Felici, Tamara AU - Felici T AD - Department. of Cardiovascular Sciences, Fondazione Policlinico Universitario A. Gemelli IRCCS, Universita Cattolica del Sacro Cuore, Rome, Italy. FAU - Mazzotta, Francesco AU - Mazzotta F AD - Diabetes Care Unit, Internal Medicine, Fondazione Policlinico Universitario A. Gemelli IRCCS, Universita Cattolica del Sacro Cuore, Rome, Italy. FAU - De Vita, Antonio AU - De Vita A AD - Department. of Cardiovascular Sciences, Fondazione Policlinico Universitario A. Gemelli IRCCS, Universita Cattolica del Sacro Cuore, Rome, Italy. FAU - Rizzo, Emanuele AU - Rizzo E AD - Diabetes Care Unit, Internal Medicine, Fondazione Policlinico Universitario A. Gemelli IRCCS, Universita Cattolica del Sacro Cuore, Rome, Italy. FAU - Cambise, Nello AU - Cambise N AD - Department. of Cardiovascular Sciences, Fondazione Policlinico Universitario A. Gemelli IRCCS, Universita Cattolica del Sacro Cuore, Rome, Italy. FAU - Belmusto, Antonietta AU - Belmusto A AD - Department. of Cardiovascular Sciences, Fondazione Policlinico Universitario A. Gemelli IRCCS, Universita Cattolica del Sacro Cuore, Rome, Italy. FAU - Pitocco, Dario AU - Pitocco D AD - Diabetes Care Unit, Internal Medicine, Fondazione Policlinico Universitario A. Gemelli IRCCS, Universita Cattolica del Sacro Cuore, Rome, Italy. FAU - Lanza, Gaetano Antonio AU - Lanza GA AUID- ORCID: 0000-0003-2187-6653 AD - Department. of Cardiovascular Sciences, Fondazione Policlinico Universitario A. Gemelli IRCCS, Universita Cattolica del Sacro Cuore, Rome, Italy. gaetanoantonio.lanza@unicatt.it. LA - eng PT - Journal Article PT - Randomized Controlled Trial DEP - 20240110 PL - United States TA - Endocrine JT - Endocrine JID - 9434444 RN - 0 (Insulin) RN - 0 (Hypoglycemic Agents) RN - 0 (Blood Glucose) SB - IM MH - Humans MH - Insulin MH - Hypoglycemic Agents/adverse effects MH - *Diabetes Mellitus, Type 2 MH - *Diabetes Mellitus, Type 1 MH - Blood Glucose Self-Monitoring MH - Blood Glucose MH - *Autoimmune Diseases MH - *Hyperglycemia/drug therapy MH - Injections, Subcutaneous MH - *Cardiovascular System MH - Insulin Infusion Systems/adverse effects PMC - PMC10987338 OTO - NOTNLM OT - Continuous glucose monitoring OT - Continuous subcutaneous insulin injection OT - Flow-mediated dilatation OT - Heart rate variability OT - Type 2 diabetes mellitus COIS- The authors declare no competing interests. EDAT- 2024/01/10 12:43 MHDA- 2024/04/04 06:44 PMCR- 2024/01/10 CRDT- 2024/01/10 11:20 PHST- 2023/09/23 00:00 [received] PHST- 2023/12/08 00:00 [accepted] PHST- 2024/04/04 06:44 [medline] PHST- 2024/01/10 12:43 [pubmed] PHST- 2024/01/10 11:20 [entrez] PHST- 2024/01/10 00:00 [pmc-release] AID - 10.1007/s12020-023-03651-w [pii] AID - 3651 [pii] AID - 10.1007/s12020-023-03651-w [doi] PST - ppublish SO - Endocrine. 2024 Apr;84(1):128-135. doi: 10.1007/s12020-023-03651-w. Epub 2024 Jan 10.