"Impact of Sexual Activity on Hypoglycemia Risk in Adults With Type 1 and Type 2 Diabetes Under Insulin Therapy and Continuous Glucose Monitoring (CGM)"
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Proportion of Sexual Activity Episodes Associated With Hypoglycemia
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Proportion of Sexual Activity Episodes Associated With Hypoglycemia
时间窗: 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.
次要结局
- 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)
