Diabetes Mellitus, Type 2Phase 4ECSIITEDNCT01468519
Exploratory CSII Trial on Erectile Dysfunction in T2DM Patients
A Phase 4 study testing Insulin in people with Diabetes Mellitus, Type 2 and Erectile Dysfunction, run by Jothydev's Diabetes and Research Centre at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 years, men only
- Conditions the study is for
- Diabetes Mellitus, Type 2, Erectile Dysfunction
- What is being tested?
- Insulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIndia
- Study dates
- Jan 2012to Nov 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
India1 site
Jothydev's Diabetes & Research Center
Thiruvananthapuram, Kerala, 695032
About this study
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2, Erectile Dysfunction
- Being tested
- Insulin
- Keywords
- Diabetes mellitus, type 2, Erectile dysfunction, continuous subcutaneous insulin infusion, CSII, insulin
- Medical subject headings
- Diabetes Mellitus, Type 2, Erectile Dysfunction, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InsulinDrug
Insulin via continuous subcutaneous insulin infusion
InsulinDrug
insulin via multiple daily injections
| Study group | Role | What they receive |
|---|---|---|
| CSII | Experimental | continuous subcutaneous insulin infusion Receives: Drug: Insulin |
| MDI | Active comparator | multiple daily insulin injections Receives: Drug: Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total International Index of Erectile Function (IIEF) score from baseline to 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
Measured: baseline and six months
Secondary outcomes (1)
Global assessment question on erectile function
Global assessment question (GAQ), "Has the treatment you have been having improved your erections? (yes/no)."
Measured: baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2011 (estimated)
- Study startJan 2012
- Primary completionSep 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jothydev's Diabetes and Research Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Jothydev Kesavadev, Jothydev's Diabetes and Research Centre
- Investigators
- Jothydev Kesavadev, MD, Principal investigator, Jothydev's Diabetes & Research CenterGopika Krishnan, BPHARM, Study chair, Jothydev's Diabetes & Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01468519
- Sponsor's protocol ID
- JDC/Pump/020/2011
- Acronym
- ECSIITED
- Status last verified
- Dec 2014
- First submitted
- 2 Jul 2011
- Last updated
- 11 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kesavadev J, Das AK, Unnikrishnan R 1st, Joshi SR, Ramachandran A, Shamsudeen J, Krishnan G, Jothydev S, Mohan V. Use of insulin pumps in India: suggested guidelines based on experience and cultural differences. Diabetes Technol Ther. 2010 Oct;12(10):823-31. doi: 10.1089/dia.2010.0027.
PubMed 20807118Kesavadev J, Balakrishnan S, Ahammed S, Jothydev S. Reduction of glycosylated hemoglobin following 6 months of continuous subcutaneous insulin infusion in an Indian population with type 2 diabetes. Diabetes Technol Ther. 2009 Aug;11(8):517-21. doi: 10.1089/dia.2008.0128.
PubMed 19698065Kesavadev J, Sadasivan Pillai PB, Shankar A, Warrier RS, Ramachandran L, Jothydev S, Krishnan G. Exploratory CSII Randomized Controlled Trial on Erectile Dysfunction in T2DM Patients (ECSIITED). J Diabetes Sci Technol. 2018 Nov;12(6):1252-1253. doi: 10.1177/1932296818794704. Epub 2018 Aug 29. No abstract available.
PubMed 30156866
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Continuous Subcutaneous Insulin Infusion (CSII) on Erectile Dysfunction in T2DM Patients: A Prospective, Exploratory, Controlled Trial
- ClinicalTrials.gov ID
- NCT01468519
- Acronym / sponsor ID
- ECSIITED / JDC/Pump/020/2011
- Conditions
- Diabetes Mellitus, Type 2, Erectile Dysfunction
- Keywords
- Diabetes mellitus, type 2, Erectile dysfunction, continuous subcutaneous insulin infusion, CSII, insulin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Jothydev's Diabetes and Research CentreUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 9 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CSII | Experimental | Drug: Insulincontinuous subcutaneous insulin infusion |
| MDI | Active comparator | Drug: Insulinmultiple daily insulin injections |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InsulinInsulin via continuous subcutaneous insulin infusion | Drug | CSII |
| Insulininsulin via multiple daily injections | Drug | MDI |
Primary outcome
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
1 secondary outcome
Global assessment question on erectile function
Time frame: baseline and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2014.
- Background: PubMed 20807118Kesavadev J, Das AK, Unnikrishnan R 1st, Joshi SR, Ramachandran A, Shamsudeen J, Krishnan G, Jothydev S, Mohan V. Use of insulin pumps in India: suggested guidelines based on experience and cultural differences. Diabetes Technol Ther. 2010 Oct;12(10):823-31. doi: 10.1089/dia.2010.0027.
- Results publication: PubMed 19698065Kesavadev J, Balakrishnan S, Ahammed S, Jothydev S. Reduction of glycosylated hemoglobin following 6 months of continuous subcutaneous insulin infusion in an Indian population with type 2 diabetes. Diabetes Technol Ther. 2009 Aug;11(8):517-21. doi: 10.1089/dia.2008.0128.
- Derived from this study: PubMed 30156866Kesavadev J, Sadasivan Pillai PB, Shankar A, Warrier RS, Ramachandran L, Jothydev S, Krishnan G. Exploratory CSII Randomized Controlled Trial on Erectile Dysfunction in T2DM Patients (ECSIITED). J Diabetes Sci Technol. 2018 Nov;12(6):1252-1253. doi: 10.1177/1932296818794704. Epub 2018 Aug 29. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jothydev Kesavadev, MD principal investigator
Jothydev's Diabetes & Research Center
Gopika Krishnan, BPHARM study chair
Jothydev's Diabetes & Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Insulin in people with Diabetes Mellitus, Type 2 and Erectile Dysfunction, run by Jothydev's Diabetes and Research Centre at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in total International Index of Erectile Function (IIEF) score from baseline to six months (time frame: baseline and six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01468519, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2014.