"Sexual Activity and Hypoglycemia Risk in Adults With Type 1 or Type 2 Diabetes Using Insulin Therapy and Continuous Glucose Monitoring"
NCT ID: NCT07286500
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2025-07-30
2028-07-10
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Jagiellonian University Medical College - Department and Clinic of Metabolic Diseases (Katedra i Klinika Chorób Metabolicznych UJ)
UNKNOWN
Medical University of Warsaw
OTHER
Responsible Party
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Locations
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Medical University of Warsaw, CSK UCK
Warsaw, , Poland
Countries
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Central Contacts
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Facility Contacts
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References
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Buskoven MEH, Kjorholt EKH, Strandberg RB, Softeland E, Haugstvedt A. Sexual dysfunction in women with type 1 diabetes in Norway: A qualitative study of women's experiences. Diabet Med. 2022 Jul;39(7):e14856. doi: 10.1111/dme.14856. Epub 2022 Apr 28.
Winkley K, Stahl D, Kar P. Diabetes distress in adults with type 1 diabetes: A systematic review and meta-analysis. Diabet Med. 2021;38(11):e14644. PMID: 34143273.
Bąk E, et al. Sexual functioning in men and women with diabetes. Int J Environ Res Public Health. 2017;14(9):1073. PMID: 28926963.
Cichocka E, Jagusiewicz M, Gumprecht J. Sexual Dysfunction in Young Women with Type 1 Diabetes. Int J Environ Res Public Health. 2020 Jun 22;17(12):4468. doi: 10.3390/ijerph17124468.
Kamiński M, et al. Glycemic variability and clinical outcomes in diabetes. Int J Angiol. 2022;31(2):97-106. PMID: 35173854.
Weinberg AE, Eisenberg M, Patel CJ, Chertow GM, Leppert JT. Diabetes severity, metabolic syndrome, and the risk of erectile dysfunction. J Sex Med. 2013 Dec;10(12):3102-9. doi: 10.1111/jsm.12318. Epub 2013 Sep 9.
Other Identifiers
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KB/112/2025
Identifier Type: -
Identifier Source: org_study_id