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NCT07286500Recruiting

"Sexual Activity and Hypoglycemia Risk in Adults With Type 1 or Type 2 Diabetes Using Insulin Therapy and Continuous Glucose Monitoring"

"Impact of Sexual Activity on Hypoglycemia Risk in Adults With Type 1 and Type 2 Diabetes Under Insulin Therapy and Continuous Glucose Monitoring (CGM)"

Source: ClinicalTrials.gov · Last updated 16 Dec 2025

Brief summary (registry, in English)

This observational study examines whether sexual activity influences the risk of hypoglycemia in adults with type 1 or type 2 diabetes treated with insulin therapy and using continuous glucose monitoring (CGM). Many patients report fear of hypoglycemia during or after sexual activity, which may affect their quality of life and willingness to engage in intimate relationships. However, no systematic research has been conducted on this topic, largely due to the sensitive nature of sexual health and the previous lack of tools to remotely monitor glucose profiles. The study uses CGM systems (LibreView or Dexcom Clarity) to evaluate glucose changes during and up to 6 hours after sexual activity. Participants will mark the start of sexual activity in their CGM application using a neutral symbol (such as a heart icon). Data will be collected remotely through secure, certified platforms without the need for discussing details of intimate life. Glucose profiles from days with and without sexual activity will be compared. Each participant will be observed for 3 months. The study will include 100 adults with type 1 or type 2 diabetes who use CGM and insulin therapy. By analyzing episodes of glucose levels below 70 mg/dL during or after sexual activity, the study aims to determine whether sexual activity is associated with an increased risk of hypoglycemia. Findings may help to better understand patient concerns, reduce unnecessary fear, and develop future clinical recommendations for safe sexual activity in individuals treated with insulin.

Status (registry)
Recruiting
Study type
Observational
Enrollment
100 (estimated)
First submitted
2 Dec 2025
Start date
Jul 2025
Primary completion date
Jul 2028
Lead sponsor
Medical University of Warsaw
NCT number
NCT07286500

What you commit to

  • Study type: Observational
  • Planned participants: 100
  • From Jul 2025 to the primary completion date, Jul 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Any condition that, in the opinion of the investigator, prevents safe participation.

Other

  • Inability to independently use the CGM application.
  • No sexual activity during the study period.
  • Withdrawal of consent at any time.

Who the study is looking for

  • Adults aged ≥18 years.
  • Diagnosis of type 1 or type 2 diabetes.
  • Current use of a continuous glucose monitoring (CGM) system.
  • Treatment with insulin therapy in any regimen.
  • Ability to operate the CGM application and mark the start of sexual activity.
  • Willingness to participate for 3 months.
  • Signed informed consent.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Medical University of Warsaw, CSK UCK
Coordinator of this site? Confirm its status
WarsawPolandRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.