Exploratory CSII Trial on Erectile Dysfunction in T2DM Patients (ECSIITED)

December 10, 2014 updated by: Dr. Jothydev Kesavadev, Jothydev's Diabetes and Research Centre

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Kerala
      • Thiruvananthapuram, Kerala, India, 695032
        • Jothydev's Diabetes & Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Male T2DM patients with HbA1c < 9%
  • Mild ED to Moderate ED as defined by International Index of Erectile Function (IIEF) questionnaire
  • Able and willing to use insulin pumps for at least the duration of the study

Exclusion Criteria:

  • Severe dysfunction in IIEF Score or duration of ED more than 3 years
  • Heart failure (class II - IV) or unstable cardiovascular disease; poorly controlled blood pressure (systolic > 170 or < 90 mmHg or diastolic > 100 or < 50 mmHg) or orthostatic hypotension
  • Medications: Substance abuse, anticancer and steroid therapy
  • Sexual dysfunction in partner, lack of stable relationship.
  • History of radical prostatectomy or pelvic surgery, significant penile deformities, penile implants, or history of stroke or spinal-cord trauma.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: CSII
continuous subcutaneous insulin infusion
Drug: Insulin
Insulin via continuous subcutaneous insulin infusion
Drug: Insulin
insulin via multiple daily injections
ACTIVE_COMPARATOR: MDI
multiple daily insulin injections
Drug: Insulin
Insulin via continuous subcutaneous insulin infusion
Drug: Insulin
insulin via multiple daily injections

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in total International Index of Erectile Function (IIEF) score from baseline to six months
Time Frame: baseline and six months
IIEF quetionnaire is a standardised and validated 15-item self-evaluation scale that provides pre-post treatment clinic evaluations of erectile function, orgasmic function, sexual desire, satisfaction in sexual intercourse and general satisfaction
baseline and six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global assessment question on erectile function
Time Frame: baseline and 6 months
Global assessment question (GAQ), "Has the treatment you have been having improved your erections? (yes/no)."
baseline and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jothydev's Diabetes and Research Centre

Investigators

  • Principal Investigator: Jothydev Kesavadev, MD, Jothydev's Diabetes & Research Center
  • Study Chair: Gopika Krishnan, BPHARM, Jothydev's Diabetes & Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (ACTUAL)

September 1, 2014

Study Completion (ACTUAL)

November 1, 2014

Study Registration Dates

First Submitted

July 2, 2011

First Submitted That Met QC Criteria

November 8, 2011

First Posted (ESTIMATE)

November 9, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

December 11, 2014

Last Update Submitted That Met QC Criteria

December 10, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JDC/Pump/020/2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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