Dataset Information

Insulin pump treatment vs. multiple daily insulin injections in patients with poorly controlled Type 2 diabetes mellitus: a comparison of cardiovascular effects.

ABSTRACT:

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.

SUBMITTER: Tremamunno S

PROVIDER: S-EPMC10987338 | biostudies-literature | 2024 Apr

REPOSITORIES: biostudies-literature

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Publications

Insulin pump treatment vs. multiple daily insulin injections in patients with poorly controlled Type 2 diabetes mellitus: a comparison of cardiovascular effects.

Tremamunno Saverio S Tartaglione Linda L Telesca Alessandro A Rizzi Alessandro A Felici Tamara T Mazzotta Francesco F De Vita Antonio A Rizzo Emanuele E Cambise Nello N Belmusto Antonietta A Pitocco Dario D Lanza Gaetano Antonio GA

Endocrine 20240110 1

<h4>Aims</h4>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.<h4>Methods</h4>We enrolled T2DM patients ...[more]

PMID: 38197988

Similar Datasets

Project description:ObjectiveTo investigate the long term effects of continuous subcutaneous insulin infusion (insulin pump therapy) on cardiovascular diseases and mortality in people with type 1 diabetes.DesignObservational study.SettingSwedish National Diabetes Register, Sweden 2005-12.Participants18,168 people with type 1 diabetes, 2441 using insulin pump therapy and 15,727 using multiple daily insulin injections.Main outcome measuresCox regression analysis was used to estimate hazard ratios for the outcomes, with stratification of propensity scores including clinical characteristics, risk factors for cardiovascular disease, treatments, and previous diseases.ResultsFollow-up was for a mean of 6.8 years until December 2012, with 114,135 person years. With multiple daily injections as reference, the adjusted hazard ratios for insulin pump treatment were significantly lower: 0.55 (95% confidence interval 0.36 to 0.83) for fatal coronary heart disease, 0.58 (0.40 to 0.85) for fatal cardiovascular disease (coronary heart disease or stroke), and 0.73 (0.58 to 0.92) for all cause mortality. Hazard ratios were lower, but not significantly so, for fatal or non-fatal coronary heart disease and fatal or non-fatal cardiovascular disease. Unadjusted absolute differences were 3.0 events of fatal coronary heart disease per 1000 person years; corresponding figures were 3.3 for fatal cardiovascular disease and 5.7 for all cause mortality. When lower body mass index and previous cardiovascular diseases were excluded, results of subgroup analyses were similar to the results from complete data. A sensitivity analysis of unmeasured confounders in all individuals showed that an unmeasured confounders with hazard ratio of 1.3 would have to be present in >80% of the individuals treated with multiple daily injections versus not presence in those treated with pump therapy to invalidate the significantly lower hazard ratios for fatal cardiovascular disease. Data on patient education and frequency of blood glucose monitoring were missing, which might have influenced the observed association.ConclusionAmong people with type 1 diabetes use of insulin pump therapy is associated with lower cardiovascular mortality than treatment with multiple daily insulin injections.

Project description:Abstract In the traditional step-up approach, patients with poorly-controlled T2DM are eventually advanced to multiple daily insulin injections (MDI). However, some on advanced insulin therapy (AIT) continue to have poor control due to poor compliance with MDI and fear of insulin-induced weight gain. The recent guidelines recommend the use of anti-hyperglycemic agents with weight loss benefits, such as SGLT2i or GLP1 RA, with basal insulin before the patients are advanced to MDI. Objective: To determine if de-escalating from AIT to the combined use of metformin, SGLT2i, GLP1 RA and basal insulin by using the stepping-down approach is a better option than MDI in obese patients with poorly- controlled T2DM on AIT. Research Design: This pilot, prospective, randomized, open-label, controlled, parallel-group trial enrolled 22 obese patients with T2DM on AIT, who had BMI ≥30 kg/m2, A1c >8% and eGFR >45. Patients were randomized to either intervention (Step-Down) or control (MDI) group. In the control group, the patient was advised to remain on MDI. In the intervention group, all prandial insulin injections were discontinued; but the patient remained on the basal insulin and metformin to which SGLT2i, Empagliflozin, and GLP1 RA, Dulaglutide, were added. They were followed up for 16 weeks. The primary outcome was A1c change and secondary outcomes were the change in fasting BG, weight, BP, HR, fasting lipids, serum Na and K, serum Cr, liver enzymes, CBC and Diabetes Medications Satisfaction (DM-SAT) scores at 16 weeks. Results: There was no difference in A1c between 2 groups (10.36% vs 9.69%;p=0.171) at baseline. However, A1c was significantly lower at 4 weeks (9.54% vs 7.31%; p=0.0088) and 16 weeks (9.7% vs 8.25%; p<0.001) in intervention group (n=10). Compared to baseline, in the control group (n=8), there was no significant change at secondary outcome variables except slightly higher SBP at 16 weeks. In intervention group, compared to baseline, there was a significant decrease in weight (-16.38 Lbs; p=0.003), BMI (-3.06; p<0.001), LDL cholesterol (-15.7 mg/d; p=0.0378), total cholesterol (-18.5 mg/dL; p=0.0386), total daily insulin dose (-57.3 units; p<0.001) and a significant improvement in DM-SAT patient satisfaction 0-100 scores - total score (+45.3; p <0.001) and subscale scores (Convenience +35.28, p =0.019; Lifestyle +35.8, p=0.0052; Medical control +51.3, p<0.001; Wellbeing +47.2,p=0.0091) at 16 weeks. Conclusions: De-escalating from AIT to the combined use of metformin, SGLT2i, GLP1 RA and basal insulin in obese patients with poorly-controlled T2DM by using the stepping-down approach results in the significant improvement in glycemic control, weight loss, and significantly higher patient satisfaction. This noble stepping-down approach may be a better option than continuing MDI in such patients. This pilot study result needs to be confirmed with a larger trial. ClinicalTrials ID: NCT02846233

Dataset Information

Insulin pump treatment vs. multiple daily insulin injections in patients with poorly controlled Type 2 diabetes mellitus: a comparison of cardiovascular effects.

Aims

Methods

Results

Conclusions

Publications

Insulin pump treatment vs. multiple daily insulin injections in patients with poorly controlled Type 2 diabetes mellitus: a comparison of cardiovascular effects.

Similar Datasets

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