"Sexual Activity and Hypoglycemia Risk in Adults With Type 1 or Type 2 Diabetes Using Insulin Therapy and Continuous Glucose Monitoring"

NCT07286500 | Recruiting

• 1 other identifier: KB/112/2025
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 1 Diabetes (T1D); Type 2 Diabetes (T2DM); Hypoglycemia

Keywords

Sexual Activity; Hypoglycemia; Glucose Variability; Continuous Glucose Monitoring; CGM; Insulin Therapy; Type 1 Diabetes; Type 2 Diabetes; Diabetes Complications

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months per participant

Secondary Outcomes (2)

• Frequency of Hypoglycemia on Sexual Activity Days vs. Non-Activity Days

  3 months per participant

• Mean Glucose Level During and After Sexual Activity

  3 months per participant

Other Outcomes (2)

• Number of Sexual Activity Episodes Recorded per Participant

  3 months per participant

• Proportion of Participants Completing the Full Observation Period With at Least One Recorded Sexual Activity Episode

  3 months per participant

Study Arms (1)

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

Interventions

No intervention OTHER

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

Diabetes Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Warsaw: lead
• Jagiellonian University Medical College - Department and Clinic of Metabolic Diseases (Katedra i Klinika Chorób Metabolicznych UJ): collaborator

Study Sites (1)

Medical University of Warsaw, CSK UCK

Warsaw, 02-097, Poland

RECRUITING

Related Publications (6)

• Kamiński M, et al. Glycemic variability and clinical outcomes in diabetes. Int J Angiol. 2022;31(2):97-106. PMID: 35173854.

  BACKGROUND

• 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.

  PMID: 24010555 BACKGROUND

• Bąk E, et al. Sexual functioning in men and women with diabetes. Int J Environ Res Public Health. 2017;14(9):1073. PMID: 28926963.

  BACKGROUND

• 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.

  PMID: 32580278 BACKGROUND

• 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.

  PMID: 35460298 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Hypoglycemia; Sexual Behavior; Diabetes Complications

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Central Study Contacts

Dominika Orłowska

CONTACT

+48 22 599 2583; dominika.orlowska@uckwum.pl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: December 16, 2025
• Study Start: July 30, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 10, 2028
• Last Updated: December 16, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)