Type 1 Diabetes (T1D)SEX-HYPO-CGMNCT07286500
"Sexual Activity and Hypoglycemia Risk in Adults With Type 1 or Type 2 Diabetes Using Insulin Therapy and Continuous Glucose Monitoring"
An observational study of Type 1 Diabetes (T1D) and Type 2 Diabetes (T2DM), run by Medical University of Warsaw at 1 site in Poland.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes (T1D), Type 2 Diabetes (T2DM), Hypoglycemia
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 30 Jul 2025to 10 Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Medical University of Warsaw, CSK UCK
Warsaw, 02-097
Dominika Orłowska, +48 22 599 25 83, dominika.orlowska@uckwum.pl
About this study
Official title: "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.
Read the 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.
- Conditions
- Type 1 Diabetes (T1D), Type 2 Diabetes (T2DM), Hypoglycemia
- Being tested
- No intervention
- Keywords
- Sexual Activity, Hypoglycemia, Glucose Variability, Continuous Glucose Monitoring, CGM, Insulin Therapy, Type 1 Diabetes, Type 2 Diabetes, Diabetes Complications
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Hypoglycemia, Sexual Behavior, Diabetes Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months per participant
Secondary outcomes (2)
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.
Measured: 3 months per participant
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.
Measured: 3 months per participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start30 Jul 2025
- Primary completion1 Jul 2028 (estimated)
- Study completion10 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes (T1D)Studies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Collaborators
- Jagiellonian University Medical College - Department and Clinic of Metabolic Diseases (Katedra i Klinika Chorób Metabolicznych UJ)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07286500
- Sponsor's protocol ID
- KB/112/2025
- Acronym
- SEX-HYPO-CGM
- Status last verified
- Jan 2025
- First submitted
- 2 Dec 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kaminski M, Kulecki M, Lachowski P, Kasprzak D, Kulczycka A, Kozlowska M, Klause D, Uruska A, Michalski M, Zozulinska-Ziolkiewicz D. Erectile Dysfunction in Individuals with Type 1 Diabetes is Associated with Long-term Metabolic Control and Diabetic Complications: A Cross-Sectional Study. Int J Angiol. 2022 Jan 13;31(2):97-106. doi: 10.1055/s-0041-1735209. eCollection 2022 Jun.
PubMed 35833179Weinberg 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.
PubMed 24010555Bąk 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.
PubMed 32580278Buskoven 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.
PubMed 35460298Winkley 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Impact of Sexual Activity on Hypoglycemia Risk in Adults With Type 1 and Type 2 Diabetes Under Insulin Therapy and Continuous Glucose Monitoring (CGM)"
- ClinicalTrials.gov ID
- NCT07286500
- Acronym / sponsor ID
- SEX-HYPO-CGM / KB/112/2025
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Collaborators
- Jagiellonian University Medical College - Department and Clinic of Metabolic Diseases (Katedra i Klinika Chorób Metabolicznych UJ)
- Study start
- 30 Jul 2025 (actual)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 10 Jul 2028 (estimated)
- First posted
- 16 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabetes Cohort | – | Other: No interventionAdults 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No 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 | Other | Diabetes Cohort |
Primary outcome
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.
2 secondary outcomes
Frequency of Hypoglycemia on Sexual Activity Days vs. Non-Activity Days
Time frame: 3 months per participant
Mean Glucose Level During and After Sexual Activity
Time frame: 3 months per participant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Background: PubMed 35833179Kaminski M, Kulecki M, Lachowski P, Kasprzak D, Kulczycka A, Kozlowska M, Klause D, Uruska A, Michalski M, Zozulinska-Ziolkiewicz D. Erectile Dysfunction in Individuals with Type 1 Diabetes is Associated with Long-term Metabolic Control and Diabetic Complications: A Cross-Sectional Study. Int J Angiol. 2022 Jan 13;31(2):97-106. doi: 10.1055/s-0041-1735209. eCollection 2022 Jun.
- Background: PubMed 24010555Weinberg 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.
- BackgroundBąk E, et al. Sexual functioning in men and women with diabetes. Int J Environ Res Public Health. 2017;14(9):1073. PMID: 28926963.
- Background: PubMed 32580278Cichocka 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.
- Background: PubMed 35460298Buskoven 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.
- BackgroundWinkley 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes (T1D) and Type 2 Diabetes (T2DM), run by Medical University of Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dominika Orłowska (+48 22 599 2583, dominika.orlowska@uckwum.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Sexual Activity Episodes Associated With Hypoglycemia (time frame: 3 months per participant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07286500, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025; AzTrials last refreshed its copy on 6 Nov 2026.