RecruitingNCT07286500

"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)"


Sponsor

Medical University of Warsaw

Enrollment

100 participants

Start Date

Jul 30, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is tracking blood sugar changes during and after sexual activity in adults with type 1 or type 2 diabetes who use insulin and a continuous glucose monitor (CGM), to better understand the risk of low blood sugar (hypoglycemia) in this situation. **You may be eligible if...** - You are 18 or older with type 1 or type 2 diabetes - You currently use a continuous glucose monitor (CGM) - You are on insulin therapy (any type of regimen) - You are able to use the CGM app and mark when sexual activity begins - You are willing to participate for 3 months and have sexual activity during the study period **You may NOT be eligible if...** - You cannot independently operate a CGM app - You do not expect to have sexual activity during the 3-month study period - You withdraw your consent - You have a condition the investigator feels makes participation unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERNo intervention

This is an observational study. No intervention is assigned. Participants continue their usual insulin therapy and self-management. Sexual activity is self-initiated and only marked within the CGM application for observational purposes


Locations(1)

Medical University of Warsaw, CSK UCK

Warsaw, Poland

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NCT07286500


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