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.
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.
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.
Adults with type 1 or type 2 diabetes who use continuous glucose monitoring (CGM) and insulin therapy. Participants will be recruited from diabetes clinics and outpatient practices. All participants must be willing to record sexual activity in the CGM application and share anonymized CGM data for analysis.
Cohort
Prospective
No intervention
Other interventionThis 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
Proportion of Sexual Activity Episodes Associated With Hypoglycemia
Hypoglycemia is defined as a glucose value below 70 mg/dL occurring during sexual activity or within 6 hours after its completion. Episodes will be identified through CGM data, using participant-marked sexual activity timestamps. Each sexual activity event will be analyzed for the presence or absence of hypoglycemia, and the proportion of events associated with hypoglycemia will be calculated.
Frequency of Hypoglycemia on Sexual Activity Days vs. Non-Activity Days
Comparison of the number of hypoglycemic episodes (glucose \<70 mg/dL) during sexual activity and within 6 hours afterward versus matched time intervals on days without sexual activity. Glucose values will be obtained from CGM reports.
Mean Glucose Level During and After Sexual Activity
Mean interstitial glucose during sexual activity and up to 6 hours after its completion, compared with mean glucose levels on matched control days without sexual activity, based on CGM data.
Number of Sexual Activity Episodes Recorded per Participant
Total number of sexual activity episodes marked by each participant in the CGM application during the 3-month observation period. This serves as a feasibility and compliance indicator for event recording in a sensitive clinical context.
Proportion of Participants Completing the Full Observation Period With at Least One Recorded Sexual Activity Episode
Proportion of enrolled participants who complete the 3-month observation period and record at least one episode of sexual activity in the CGM app. This outcome assesses feasibility, retention, and participant engagement.
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Medical University of Warsaw
Lead sponsor
Jagiellonian University Medical College - Department and Clinic of Metabolic Diseases (Katedra i Klinika Chorób Metabolicznych UJ)
Collaborator
