Actively Recruiting

Age: 18Years +
All Genders
ID07286500

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

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

100

Participants Needed

1

Research Sites

1 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 research aims to understand if sexual activity affects the risk of low blood sugar (hypoglycemia) in adults with type 1 or type 2 diabetes who use insulin therapy and continuous glucose monitoring (CGM). Sexual health is important but often overlooked in diabetes care, and fear of hypoglycemia during or after sexual activity may reduce quality of life. The study addresses this gap using new remote monitoring technology to study glucose changes related to sexual activity. Participants will use CGM systems like LibreView or Dexcom Clarity to track glucose levels during and up to 6 hours after sexual activity, which they mark in their CGM app using a neutral symbol. The study is observational with no assigned treatments; participants continue their usual insulin therapy and self-management. Each person will be observed for 3 months, comparing glucose data from sexual activity days to days without sexual activity. During the study, researchers will collect glucose data remotely and receive basic clinical information from healthcare providers. They will analyze the proportion of sexual activity episodes linked to hypoglycemia and compare frequency and mean glucose levels on days with and without sexual activity. Participants' data are anonymized and securely handled. The study hopes to help reduce patient fears and guide future recommendations for safe sexual activity with insulin therapy.

CONDITIONS

Brief 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 618 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.
Not Eligible

You will not qualify if you...

  • 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.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - 3 months

Participants continue their usual insulin therapy and self-management while using continuous glucose monitoring (CGM). They mark sexual activity episodes in their CGM application for observational purposes.

Participants use their CGM device daily and mark sexual activity episodes as they occur

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

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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Published Research Related To This Trial

Erectile Dysfunction in Individuals with Type 1 Diabetes is Associated with Long-term Metabolic Control and Diabetic Complications: A Cross-Sectional Study.

Mikołaj Kamiński, Michał Kulecki, Paweł Lachowski...

https://pubmed.ncbi.nlm.nih.gov/35833179

Sexual dysfunction in women with type 1 diabetes in Norway: A qualitative study of women's experiences.

Maren E H Buskoven, Eir K H Kjørholt, Ragnhild B Strandberg...

https://pubmed.ncbi.nlm.nih.gov/35460298