Impact of Eating Disorders on the Glycemic Profile of Type 1 Diabetic Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Evaluation of the impact of TCA on the glycemic profile of patients with type 1 diabetes
研究概览
简要总结
Eating disorders (EDs), as classified by the American Psychiatric Association's DSM-5, have an estimated lifetime prevalence of 0.6% in the Caucasian adult population, with a male-to-female ratio of 1:8, and begin in 84% to 87% of cases between the ages of 15 and 25.
Anorexia nervosa (AN) is an eating disorder that represents a significant public health concern due to its impact on long-term morbidity and mortality. The incidence of AN is steadily increasing in many countries, particularly in France, with a prevalence of 2-3% among adolescents and young adults. A 10-year mortality rate of 5-10% has been reported, making AN the psychiatric disorder with the highest mortality rate. This predominantly female disorder (female-to-female ratio of 1:9) is defined by the persistent association of disordered eating behavior, distorted body image, and obsessions with weight and food, with detrimental health consequences. Anorexia nervosa (AN) exposes patients to numerous somatic and neuropsychiatric complications, which are poor prognostic factors. Its etiopathogenesis is multifactorial and involves environmental, psychological, genetic, and sociocultural factors. Bulimia nervosa (BN) is also associated with an intense fear of gaining weight. There is a disturbance of body image characterized by profound dissatisfaction with weight and physical appearance. BN is characterized by binge-eating episodes (consuming a large amount of food in a short period of time, associated with a feeling of loss of control) followed by inappropriate compensatory behaviors such as self-induced vomiting, misuse of laxatives, diuretics, or other medications; fasting; and excessive exercise. Individuals with bulimia nervosa generally have a subnormal body mass index (BMI), making diagnosis more difficult.
Type 1 diabetes is an autoimmune disease characterized by the destruction of the beta cells of the pancreatic islets of Langerhans, leading to a deficiency in insulin secretion. Generally, the diagnosis is made in childhood or adolescence, but late-diagnosed forms exist, forming an entity called latent autoimmune diabetes in adults (LADA), also known as type 1 diabetes. Diagnosis is made by measuring antibodies specific to type 1 diabetes: anti-GAD and anti-IA2 antibodies as the first-line tests, and anti-ZnT8 antibodies as a second-line test. Drug treatment primarily relies on continuous insulin administration via multiple daily injections or an insulin pump. Nutritional management is a cornerstone of treatment, playing a crucial role in glycemic control and the prevention of metabolic complications.
"Diabulimia" is a recent term describing a specific eating disorder in patients with type 1 diabetes. It is characterized by a voluntary restriction of insulin administration for the purpose of weight loss, at the expense of optimal glycemic control. This condition involves several complex factors (such as insulin injection, capillary blood glucose, emotions, and body image) that link diabetes management to the patient's mental health.
"Diabulimia" is not yet recognized as a distinct medical entity, lacks precise diagnostic criteria, and is difficult to detect. However, the serious consequences it entails, such as diabetic ketoacidosis in the short term and the chronic complications of hyperglycemia in the long term, make its screening essential.
详细描述
Technological advances in the treatment of type 1 diabetes have been significant in recent years and have considerably improved the management of the disease.
Continuous glucose monitoring has radically changed the management of type 1 diabetes by empowering patients to self-manage and adjust their insulin therapy. Glucose monitoring methods have evolved considerably over the last few decades: from urine tests before the 1980s, to capillary blood glucose self-monitoring with a portable blood glucose meter introduced in 1978, to continuous glucose monitoring (CGM) methods that emerged in 1999.
Recently, CGMs have replaced capillary blood glucose meters. CGMs include sensors and transmitters that send blood glucose readings to a receiving system such as a meter, smartphone, or smartwatch, and potentially to a cloud service.
Currently in France, all diabetic patients on multi-injection or continuous insulin pump administration are eligible for reimbursement of a continuous glucose monitoring system allowing the measurement of interstitial glucose by wearing an interstitial glucose sensor. This study aims to evaluate blood glucose readings collected by two devices:
- Abbott FreeStyle Libre (FSL) is a flash interstitial glucose monitoring system where glucose is continuously monitored via intermittent scanning (ISGS). It is a standalone interstitial glucose sensor that collects glucose data by scanning the sensor.
- Dexcom is a real-time continuous glucose monitoring (RTGS) system. The reader provides a blood glucose reading every 5 minutes, along with a trend arrow and data collection over several hours (up to 24 hours).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 40 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients
- •Patients aged 18 to 40 years
- •Patients diagnosed with type 1 diabetes (positive for anti-GAD, anti-IA2, and anti-ZnT8 antibodies)
- •Patients on insulin therapy alone (basal-bolus regimen or insulin pump)
- •Patients using a continuous glucose monitoring device such as an FSL or DEXCOM
- •Patients followed in the clinical nutrition and/or diabetology department of the Rouen University Hospital and the Le Havre Hospital
- •Social security coverage
- •Patients who have agreed to participate in the study
排除标准
- •Patients taking antidiabetic medication other than insulin therapy alone
- •Patients with limited understanding of spoken or written French
- •Individuals deprived of their liberty by an administrative or judicial decision, or individuals subject to legal protection measures for adults
- •Individuals under guardianship, conservatorship, or other protective supervision
- •Pregnant or breastfeeding women
研究组 & 干预措施
Evaluate the impact of TCA on the glycemic profile of type 1 diabetic patients with eating disorder
Correlation of self-documented questionnaires completed by the patient (J0) and data from CGM devices over the last 3 months collected by the diabetologist, as part of care.
Evaluate the impact of TCA on the glycemic profile of type 1 diabetic patients without eating disord
Correlation of self-documented questionnaires completed by the patient (J0) and data from CGM devices over the last 3 months collected by the diabetologist, as part of care.
结局指标
主要结局
Evaluation of the impact of TCA on the glycemic profile of patients with type 1 diabetes
时间窗: 3 months
The main objective of the study is to evaluate the impact of TCA on the glycemic profile of patients with type 1 diabetes. Time spent in and above target glycemic range over the past 3 months will be assessed in patients with an eating disorder (ED).
次要结局
- Evaluate the impact of TCA in type 1 diabetic patients on HbA1c measurement(1 day)
- Evaluate the impact of TCA in type 1 diabetic patients on complications of diabetes (GMI (glucose management indicator))(1 day)
- Evaluate the impact of TCA in type 1 diabetic patients on complications of diabetes (microangiopathic (diabetic retinopathy))(3 months)
- Evaluate the impact of TCA in type 1 diabetic patients on complications of diabetes (microangiopathic (diabetic neuropathy))(3 months)
- Evaluate the impact of TCA in type 1 diabetic patients on complications of diabetes (microangiopathic (diabetic nephropathy))(3 months)
- Evaluate the impact of TCA in type 1 diabetic patients on associated factors (anxiety)(1 day)
- Evaluate the impact of TCA in type 1 diabetic patients on associated factors (depression)(1 day)
- Assessment of time spent in and above target blood glucose levels over the past 3 months.(3 months)
