Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Effects of Continuous Subcutaneous Insulin Infusion (CSII) on Erectile Dysfunction in T2DM Patients: A Prospective, Exploratory, Controlled Trial
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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