"Sexual Activity and Hypoglycemia Risk in Adults With Type 1 or Type 2 Diabetes Using Insulin Therapy and Continuous Glucose Monitoring" (SEX-HYPO-CGM)

December 2, 2025 updated by: Medical University of Warsaw

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Sexual health is an integral component of overall well-being and quality of life, including for adults living with chronic diseases such as diabetes. Despite its importance, sexual health is often overlooked in clinical practice. Health care professionals rarely initiate conversations about sexual functioning due to limited training, lack of tools, or concern about patient discomfort. At the same time, many patients with diabetes report fear of hypoglycemia during or after sexual activity, and partners frequently share similar concerns. These fears may lead to reduced sexual activity and diminished quality of life.

Hypoglycemia remains one of the most common and clinically significant complications of insulin therapy. Glucose levels below 70 mg/dL require prompt intake of carbohydrates or adjustment of glucose-lowering treatment to prevent further decline. Physical exertion- including sexual activity-may lead to early or delayed hypoglycemia, occurring even several hours after the activity. On the other hand, emotional excitement during sexual activity may trigger counter-regulatory hormones such as adrenaline or cortisol, potentially causing hyperglycemia. Despite these observations, no systematic study has evaluated the relationship between sexual activity and glucose fluctuations in adults with diabetes. Historically, such research was hindered by the intimate nature of the subject and the absence of remote monitoring tools.

The introduction of continuous glucose monitoring (CGM) systems, together with cloud-based platforms such as LibreView and Dexcom Clarity, enables the remote and secure assessment of glucose trends without requiring direct discussion of intimate details. This study leverages these technologies to evaluate whether sexual activity increases the risk of hypoglycemia in adults with type 1 or type 2 diabetes treated with insulin.

Each participant will be observed for 3 months. Participants will mark the beginning of sexual activity within their CGM application using a neutral icon (e.g., a heart symbol). Glucose trends during and for up to 6 hours following the activity will be analyzed and compared to glucose profiles from days without sexual activity. Health care providers will also complete a brief online form with basic clinical information about each participant, including age, diabetes type, disease duration, treatment regimen, and CGM system used.

The study aims to enroll 100 adults. This pragmatic sample size reflects the exploratory nature of the project and the absence of prior research in this area. Based on general population estimates, participants are expected to report an average of approximately 10 episodes of sexual activity over the 3-month observation period. The primary endpoint is the proportion of sexual activity episodes associated with hypoglycemia, defined as glucose levels below 70 mg/dL occurring during or after the activity.

All data will be anonymized. Each patient will receive a unique study code that does not contain personal identifiers. Only the principal investigator and scientific supervisor will have access to the code key. Glucose data and sexual activity markers will be exported from CGM applications in encrypted form and analyzed exclusively in de-identified datasets. After completion of the study and statistical analysis, all data will be securely deleted according to institutional procedures.

The results of this study may provide the first empirical evidence on the relationship between sexual activity and hypoglycemia risk in individuals using insulin therapy. If a relationship is confirmed, the findings may guide future recommendations to improve safety around sexual activity. If no association is found, the results may help reduce unnecessary anxiety among patients and improve open communication in clinical practice.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Poland
      • Warsaw, Poland, 02-097
        • Recruiting
        • Medical University of Warsaw, CSK UCK
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Diabetes Cohort
Adults with type 1 or type 2 diabetes treated with insulin therapy and using continuous glucose monitoring (CGM). Participants are observed for 3 months. They mark sexual activity in their CGM application, and glucose values during and up to 6 hours after the activity are analyzed and compared with glucose data from days without sexual activity.
Other: No 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Sexual Activity Episodes Associated With Hypoglycemia
Time Frame: 3 months per participant
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.
3 months per participant

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of Hypoglycemia on Sexual Activity Days vs. Non-Activity Days
Time Frame: 3 months per participant
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.
3 months per participant
Mean Glucose Level During and After Sexual Activity
Time Frame: 3 months per participant
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.
3 months per participant

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Sexual Activity Episodes Recorded per Participant
Time Frame: 3 months 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.
3 months per participant
Proportion of Participants Completing the Full Observation Period With at Least One Recorded Sexual Activity Episode
Time Frame: 3 months per participant
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.
3 months per participant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Warsaw

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 30, 2025

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 10, 2028

Study Registration Dates

First Submitted

December 2, 2025

First Submitted That Met QC Criteria

December 2, 2025

First Posted (Actual)

December 16, 2025

Study Record Updates

Last Update Posted (Actual)

December 16, 2025

Last Update Submitted That Met QC Criteria

December 2, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KB/112/2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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