Exploratory CSII Trial on Erectile Dysfunction in T2DM Patients
Condition: Diabetes Mellitus, Type 2; Erectile Dysfunction
MeSH terms: Erectile Dysfunction; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Erectile dysfunction (ED) is a common form of organic sexual dysfunction in males with
      diabetes, with estimated incidence rates between 35 and 75%. Fifty percent of men with
      diabetes are afflicted with ED within 10 years of their diagnosis. Long-term poor glycemic
      control increases the risk ED. Although comparatively costly, advantages of CSII over other
      modes of insulin delivery include better glycemic control, fewer hypoglycemic episodes, and
      improved quality of life. In a previously published study, on CSII in T2DM, in our center,
      83% of men reported an improvement in sexual function as a secondary endpoint. The current
      study is planned to further explore this finding.
    

Detailed description: 
      Background Erectile dysfunction (ED) is a common form of organic sexual dysfunction in males
      with diabetes, with estimated incidence rates between 35 and 75%. Fifty percent of men with
      diabetes are afflicted with ED within 10 years of their diagnosis. Long-term poor glycemic
      control increases the risk ED. Neuropathy is a major contributor to diabetic ED. Other causes
      of ED in diabetes include vascular disease, metabolic control, nutrition, endocrine
      disorders, psychogenic factors, and drugs.

      Continuous Sub-cutaneous Insulin Infusion The Continuous Subcutaneous Insulin Infusion (CSII)
      Pump (insulin pump for short) is a pager-sized device which can be connected to the body
      through an infusion set so as to deliver insulin continuously. It consists of a disposable
      reservoir for insulin, a disposable infusion set, including a cannula for subcutaneous
      insertion and a tubing system which connects the insulin reservoir to the cannula. Insulin
      pump therapy by itself is not a new therapy for diabetes mellitus. It is an alternative
      delivery mechanism for administration of insulin and is found to be superior to ordinary
      syringes and insulin pens. Insulin pumps were popularly used in T1DM but nowadays insulin
      pumps are commonly used in T2DM patients as well.

      A guideline for use of insulin pumps in India has been recently published in Diabetes
      Technology and Therapeutics journal, which included participation from Jothydev's Diabetes
      Center.

      Although comparatively costly, advantages of CSII over other modes of insulin delivery
      include better glycemic control, fewer hypoglycemic episodes, and improved quality of life.
      Our own center has reported a significant reduction in HbA1c when subjects in multiple daily
      insulin switched to CSII.

      Relevant Clinical Data In the aforementioned study of CSII in Type 2 diabetes patients in our
      study, 83% of men reported an improvement in sexual function when queried after 6 months on
      CSII. The mode of improvement and magnitude of this effect is not known, and needs to be
      ascertained in prospective trials. The present study proposal is to corroborate the findings,
      and obtain clarification of effect size.

      Potential Benefits & Risks The following improvements can be expected following initiation of
      insulin pump therapy.

        -  Improvement in HbA1c

        -  Reduction in blood sugar fluctuations

        -  Reduction in major and minor hypoglycemic episodes

        -  Reduction in total daily dose of insulin

        -  Improvement in QOL

      The following are some risks/disadvantages of using insulin pump therapy

        -  Cost of pumps and consumables is higher than other modes of insulin delivery

        -  There is a risk of infection if the cannula is not changed once in every three days.

        -  Improper use of insulin pump boluses can lead to insulin stacking and low sugars.

      Proper patient education and monitoring will be part of the study to overcome the risks of
      insulin pump therapy.
    

Intervention name(s): Insulin; Insulin
Intervention type(s): Drug; Drug
Intervention description(s): Insulin via continuous subcutaneous insulin infusion; insulin via multiple daily injections
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes mellitus, type 2; Erectile dysfunction; continuous subcutaneous insulin infusion; CSII; insulin