"Sexual Activity and Hypoglycemia Risk in Adults With Type 1 or Type 2 Diabetes Using Insulin Therapy and Continuous Glucose Monitoring"
Recruiting · NCT07286500 · Observational (researchers observe without assigning treatment) · Lead sponsor: Medical University of Warsaw
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
Inclusion criteria
- 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.
Exclusion criteria
- Inability to independently use the CGM application.
- No sexual activity during the study period.
- Withdrawal of consent at any time.
- Any condition that, in the opinion of the investigator, prevents safe participation.
Where it is running
1 location listed.
- Medical University of Warsaw, CSK UCK - Warsaw, Poland