This original research from Jothydev’s Diabetes Research Centre was presented at ATTD (Advanced Technologies & Treatments for Diabetes) in February 2015 and published in Diabetes Technology & Therapeutics.
Erectile dysfunction is common in men with T2DM. We investigated the effect of continuous subcutaneous insulin infusion (CSII) in men with T2DM and ED. Twenty men were recruited for this pilot study. All patients were put on insulin +/- OHAs and a statin, with CSII in trial arm and multiple daily injections (MDI)/biphasic/basal insulin regimens in control arm. Antihypertensives were used as required.
The study was a 6-month, parallel arm, open label, non-randomized, single-blind (outcomes assessor) study. The primary endpoint was International Index of Erectile Function (IIEF). All subjects also answered Patient Health Questionnaire-9 (PHQ-9) for depression, a global assessment question of whether erections improved, and a neuropathic pain scale for peripheral neuropathy at the end of the study. Other assessments included vibration perception threshold (VPT) and tests for HbA1c, free testosterone, lipid profile, & TSH. Baseline measurements were compared using independent sample t-test. Linear regression for final IIEF score corrected for age and baseline IIEF score. All patients had normal testosterone and TSH levels. Age, A1c, PHQ-9 score, and IEEF scores were not statistically significantly different between groups at baseline (CSII: mean age 52.8 years, mean A1c 8.1; Control: 50.8 yrs, 7.8 A1c).
Patients in the CSII arm showed statistically significant improvement in total IEEF score, t(14)=5.89, p<0.0001, and in the five subdomains of IEEF. Final A1c in the CSII group was 7.5 ± 0.9 vs 8.6 ± 0.9 in the control group. More men in the CSII arm answered 'yes' to the global assessment question at the end of the study (7 vs 3). This is the first study to report improvement of erectile dysfunction with CSII.