Actively Recruiting

Age: 18Years +
All Genders
NCT07286500

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

Led by Medical University of Warsaw · Updated on 2025-12-16

100

Participants Needed

1

Research Sites

153 weeks

Total Duration

On this page

Sponsors

M

Medical University of Warsaw

Lead Sponsor

J

Jagiellonian University Medical College - Department and Clinic of Metabolic Diseases (Katedra i Klinika Chorób Metabolicznych UJ)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 5618 years
  • Diagnosed with type 1 or type 2 diabetes
  • Currently using a continuous glucose monitoring (CGM) system
  • Receiving insulin therapy with any regimen
  • Able to operate the CGM application and mark the start of sexual activity
  • Willing to participate for 3 months
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Unable to independently use the CGM application
  • No sexual activity during the study period
  • Withdrawal of consent at any time
  • Any condition that prevents safe participation, as judged by the investigator

AI-Screening

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Trial Site Locations

Total: 1 location

1

Medical University of Warsaw, CSK UCK

Warsaw, Poland, 02-097

Actively Recruiting

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Research Team

D

Dominika Orłowska

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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